California FDA 510(k) clearances, last 90 days
US companies with an FDA 510(k) clearance and a California address from Aug 2, 2026 to Oct 30, 2026. FDA data through October 30, 2026.
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Last 90 days
99 clearances in the last 90 days. The same 90 days a year earlier: 109.
For contract manufacturers and test labs
California had 99 US 510(k) clearances in the last 90 days and 415 in the last 12 months. The product code with the most clearances in this window is QEW (Peripheral Mechanical Thrombectomy With Aspiration). Contract manufacturers and test labs that sell to device companies in California can read the company, the device and the date below, then open the FDA record. Contacts for these companies come with a free month.
Top product codes
| Product code | Device type | Clearances |
|---|---|---|
QEW | Peripheral Mechanical Thrombectomy With Aspiration | 5 |
QJP | Catheter, Percutaneous, Neurovasculature | 5 |
NRY | Catheter, Thrombus Retriever | 4 |
QOF | Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents | 4 |
DQY | Catheter, Percutaneous | 2 |
| Decision date | Company | Device | FDA record |
|---|---|---|---|
| Oct 30, 2026 | Intuitive Surgical, Inc. | da Vinci Xi Surgical System (IS4000);da Vinci X Surgical System (IS4200) | K263592 |
| Oct 30, 2026 | Cepheid | Xpert Hemorrhagic Fever Panel | K262971 |
| Oct 30, 2026 | GenMark Diagnostics, Inc. | cobas eplex respiratory pathogen panel 3 | K262938 |
| Oct 30, 2026 | Cb Innovations, LLC | EXG PulseLinQ Cables (EXGPL) | K262816 |
| Oct 29, 2026 | SeaSpine Orthopedics Corporation | Virata Spinal Fixation System | K262731 |
| Oct 29, 2026 | SeaSpine Orthopedics Corporation | Convoy Expandable Corpectomy System | K262574 |
| Oct 28, 2026 | Fziomed, Inc. | Dynavisc | K262343 |
| Oct 28, 2026 | Evident Vascular, Inc. | Evident Vascular Guidance System | K261648 |
| Oct 27, 2026 | The Belport Company Inc., DBA Gingi-Pak | AquaVance Clear Fluoride Treatment | K262775 |
| Oct 26, 2026 | Expanse Medical, Inc. | FLOWRUNNER Aspiration System | K262864 |
| Oct 26, 2026 | Single Pass, Inc. | SP Electrocautery Device (SP18 Max);SP Electrocautery Device (SP20 Max) | K262720 |
| Oct 22, 2026 | Cepheid | Xpert Xpress CoV-2/Flu plus | K263333 |
| Oct 21, 2026 | Beta Bionics, Inc. | Mint ACE Pump | K263422 |
| Oct 21, 2026 | Alphatec Spine, Inc. | Calibrate MAX System; Calibrate NanoTec MAX System; Calibrate CCX Interbody System; Calibrate NanoTec CCX Interbody System | K262646 |
| Oct 21, 2026 | Toro Neurovascular, Inc. | Toro 71 Aspiration Catheter; Toro Aspiration Tubing | K262021 |
| Oct 20, 2026 | Sleepcare, LLC | Daybreak Impression Material | K262421 |
| Oct 20, 2026 | Bd Biosciences | BD OneFlow LST; BD OneFlow B-CLPD T1; BD FACSLyric Flow Cytometer, 8-color [4-2-2], 10-color [4-3-3], 12-color (4-3-5) | K260215 |
| Oct 19, 2026 | Linatech, LLC | VenusCT | K260510 |
| Oct 16, 2026 | Route 92 Medical, Inc. | Route 92 Medical Full Length 046 Reperfusion System and Aspiration Tubing Set | K263266 |
| Oct 16, 2026 | THINK Surgical, Inc. | TMINI Miniature Robotic System | K263234 |
| Oct 16, 2026 | Carecubes, Inc. | Carecube Negative Pressure Isolation Chamber (1BY) | K260180 |
| Oct 15, 2026 | Penumbra, Inc. | INDIGO Aspiration System | K262904 |
| Oct 15, 2026 | Circadia Health, Inc. | The Circadia CX00 System (CX00) | K262447 |
| Oct 14, 2026 | Intuitive Surgical, Inc. | da Vinci 5 Handheld Camera Head (470080);da Vinci 5 Handheld Camera Laparoscope, 0 degree (470081);da Vinci 5 Handheld Camera Laparoscope, 30 degree (470082);da Vinci 5 Handheld Camera Tray (400526);da Vinci 5 Firefly Imaging System | K262455 |
| Oct 14, 2026 | Masimo Corporation | Radius VSM and Accessories | K260676 |
| Oct 11, 2026 | Endovascular Engineering, Inc. | Helo Return | K253717 |
| Oct 9, 2026 | Stryker Neurovascular | Excelsior Reach Microcatheter | K261649 |
| Oct 9, 2026 | Allwin Medical Devices, Inc. | The D-Tip Denudation Pipette | K261234 |
| Oct 7, 2026 | Vista AI, Inc. | Vista AI Scan | K260092 |
| Oct 6, 2026 | Okami Medical, Inc. | LOBO Vascular Occlusion System | K262798 |
| Oct 6, 2026 | Alembic, LLC | APRO 88 Catheter | K261938 |
| Oct 6, 2026 | True Function Laboratory, Inc. | Forza | K260136 |
| Oct 5, 2026 | Inkspace Imaging, Inc. | InkSpace Imaging Small Body Array (SBA12PH15x) | K262813 |
| Oct 2, 2026 | Cepheid | Xpert Xpress CoV-2/Flu plus | K263120 |
| Sep 29, 2026 | Djo, LLC | Spinalogic Bone Growth Stimulator | K262721 |
| Sep 29, 2026 | QT Medical, Inc. | QCA 10 Electrocardiograph (QCARD-10); QCA 10W Electrocardiograph (QCARD-10W) | K260250 |
| Sep 25, 2026 | Align Technology, Inc. | Invisalign System | K262196 |
| Sep 25, 2026 | Cepheid | Xpert Respiratory Panel | K261336 |
| Sep 25, 2026 | CapsoVision, Inc. | CapsoView (CVV); CapsoCloud (CLD) | K254230 |
| Sep 25, 2026 | Life Detection Technologies | DistaSense(TM) (v1) | K254058 |
| Sep 24, 2026 | Den-Mat Holdings, LLC | MPa Max adhesive | K262252 |
| Sep 24, 2026 | Carlsmed, Inc. | corra cervical plating system | K262149 |
| Sep 23, 2026 | Elevation Spine | SABER-C System | K263049 |
| Sep 23, 2026 | SI-BONE, Inc. | iFuse Granite Onyx Implant System | K262067 |
| Sep 22, 2026 | Alfa Scientific Designs, Inc. | Instant-View hCG Combo II Cassette Test | K262299 |
| Sep 18, 2026 | Vantis Vascular, Inc. | CrossFAST Integrated Microcatheter Advanced Delivery System | K262817 |
| Sep 18, 2026 | Biolinq Incorporated | Biolinq Shine Autonomous Time-in-Range Microsensor | K262599 |
| Sep 18, 2026 | Neptune Medical, Inc. | Pathfinder Endoscope Overtube | K262262 |
| Sep 18, 2026 | Inari Medical, Inc. | Triever Duo Catheter | K253419 |
| Sep 17, 2026 | Paragon Implant Mfg., LLC | TriActive Dental Implant System | K261392 |
| Sep 16, 2026 | ClearClub | ClearClub Impression Material | K261888 |
| Sep 16, 2026 | Ceribell, Inc. | Ceribell EEG Analysis Software | K261712 |
| Sep 16, 2026 | Amptron Medical, Inc. | ElintMAX Respiratory Monitor (ElintMAX Monitor A1) | K260226 |
| Sep 16, 2026 | Route 92 Medical, Inc. | Route 92 Medical Full Length 046 Access System | K260220 |
| Sep 15, 2026 | Calyxo, Inc. | CVAC Aspiration System | K261447 |
| Sep 14, 2026 | Maduro Medical, Inc. | Radical 064 Reperfusion Catheter; Radical 076 Reperfusion Catheter; Radical Aspiration Tubing Kit | K261089 |
| Sep 11, 2026 | Beta Bionics, Inc. | iLet Dosing Decision Software | K262763 |
| Sep 11, 2026 | Beta Bionics, Inc. | Mint ACE Pump | K260001 |
| Sep 8, 2026 | Intuitive Surgical, Inc. | da Vinci Surgical System, Model IS5000 | K261823 |
| Sep 8, 2026 | Emboline, Inc. | Emboliner Embolic Protection System (EPC-03) | K261715 |
| Sep 4, 2026 | Ortho-Clinical Diagnostics, Inc. (QuidelOrtho) | Sofia 2 SARS Antigen+ FIA; Sofia 2 Lyme FIA | K254264 |
| Sep 4, 2026 | Ortho Clinical Diagnostics Inc. (QuidelOrtho) | Sofia Influenza A+B FIA; Sofia RSV FIA; Sofia Strep A+ FIA | K254262 |
| Sep 3, 2026 | Endovascular Engineering | Helo Max Thrombectomy System (HEL2090) | K261800 |
| Sep 3, 2026 | Neptune Medical, Inc. | Triton 1 System | K260503 |
| Sep 3, 2026 | MicroVention, Inc., d/b/a Terumo Neuro | Mayumi Thrombectomy System | K254035 |
| Sep 2, 2026 | Serpex Medical | Maverix Cryo Biopsy Pro (MCB Pro) (MCBP-1000); Maverix Cryo Cartridge (CC-1000) | K262420 |
| Sep 2, 2026 | Modular Medical, Inc. | Pivot Insulin Delivery System | K262153 |
| Aug 28, 2026 | Reflow Medical, Inc. | Kiba CTO Crossing Catheter | K262013 |
| Aug 28, 2026 | Imperative Care, Inc. | Zoom 4S Catheter | K261176 |
| Aug 28, 2026 | Roche Molecular Systems, Inc. | cobas Strep A Nucleic acid test for use on the cobas Liat System (07341911190); cobas Strep A Quality Control Kit (07402678190) | K260047 |
| Aug 28, 2026 | Roche Molecular Systems, Inc. | cobas Cdiff Nucleic acid test for use on the cobas Liat System (07454945190); cobas Cdiff Positive and Negative Control Kit for use on the cobas Liat System (07454970190) | K260045 |
| Aug 27, 2026 | Prismatik Dentalcraft, Inc. | Glidewell Denture Base Resin | K261802 |
| Aug 27, 2026 | Resmed Corp | EasyCare Tx 2 | K261360 |
| Aug 25, 2026 | Ceevra, Inc. | Ceevra Reveal 4 | K261595 |
| Aug 24, 2026 | Bolt Medical, Inc. | SEISMIQ Intravascular Lithotripsy System | K260246 |
| Aug 21, 2026 | Inari Medical, Inc. | Artix MT;Artix Thin-Walled Sheath | K262538 |
| Aug 20, 2026 | Hardy Diagnostics | HardyDisk AST Tebipenem 10µg (TBP10) | K262113 |
| Aug 18, 2026 | Sight Sciences, Inc. | TearCare System | K262479 |
| Aug 18, 2026 | AI Planning Logic, Inc. | Lower Limb AI (LLAI) | K261641 |
| Aug 18, 2026 | Wallaby Medical | p17 XR Microcatheter | K254071 |
| Aug 14, 2026 | Arbor Endovascular, LLC | Willow 12 Guidewire | K262424 |
| Aug 14, 2026 | Cerenovus, Inc. | MICRUSFRAME (MFR100202); MICRUSFRAME (MFR100253); MICRUSFRAME (MFR100305); MICRUSFRAME (MFR100356); MICRUSFRAME (MFR100407); MICRUSFRAME (MFR100412); MICRUSFRAME (MFR100509); MICRUSFRAME (MFR100517); MICRUSFRAME (MFR100611); MICRUSFRAME (MFR100626); MICRUSFRAME (MFR100713); MICRUSFRAME (MFR100730); MICRUSFRAME (MFR100816); MICRUSFRAME (MFR100829); MICRUSFRAME (MFR140225); MICRUSFRAME (MFR140303); MICRUSFRAME (MFR140304); MICRUSFRAME (MFR140306); MICRUSFRAME (MFR140406); MICRUSFRAME (MF | K262419 |
| Aug 12, 2026 | Alembic, LLC | APRO 35 Swift Catheter | K262392 |
| Aug 12, 2026 | Alembic, LLC | APRO 35 Swift Catheter and Alembic Aspiration Tubing | K262391 |
| Aug 12, 2026 | TriMed, Inc. | Large Compression Screws | K262344 |
| Aug 12, 2026 | Cortechs Labs, Inc. | NeuroQuant PET | K261916 |
| Aug 12, 2026 | Masimo Corporation | Masimo Root Monitoring System | K253417 |
| Aug 11, 2026 | Dexcom, Inc. | Stelo Glucose Biosensor System | K262472 |
| Aug 10, 2026 | Nova Eye, Inc. | Nova Eye iTrack 250A Canaloplasty Microcatheter (iTrack 250A) | K253468 |
| Aug 7, 2026 | The Belport Company Inc., DBA Gingi-Pak | PacTemp Automix NE | K261937 |
| Aug 7, 2026 | Cepheid | Xpert Hemorrhagic Fever | K261362 |
| Aug 7, 2026 | Intuitive Surgical, Inc. | Intuitive Endoluminal Gastrointestinal System (IG1000) | K253702 |
| Aug 7, 2026 | Leica Biosystems Imaging, Inc. | Aperio iQC DX Software | K253561 |
| Aug 7, 2026 | Leica Biosystems Imaging, Inc. | Aperio GT 450 DX; Aperio GT 180 DX | K253554 |
| Aug 7, 2026 | Aptitude Medical Systems, Inc. | Metrix COVID Test; Metrix COVID Test Pro | K253453 |
| Aug 4, 2026 | Jupiter Endovascular | Vertex Thrombectomy System | K261523 |
| Aug 4, 2026 | Sight Sciences, Inc. | OMNI Ultra Surgical System (1-110) | K253760 |
| Aug 3, 2026 | Varian Medical Systems, Inc. | Halcyon, Ethos Radiotherapy System (5.0) | K261856 |
| Aug 3, 2026 | Elevation Spine | SABER-XA System | K261408 |
- Oct 30, 2026Intuitive Surgical, Inc.
da Vinci Xi Surgical System (IS4000);da Vinci X Surgical System (IS4200)
- Oct 30, 2026Cepheid
Xpert Hemorrhagic Fever Panel
- Oct 30, 2026GenMark Diagnostics, Inc.
cobas eplex respiratory pathogen panel 3
- Oct 30, 2026Cb Innovations, LLC
EXG PulseLinQ Cables (EXGPL)
- Oct 29, 2026SeaSpine Orthopedics Corporation
Virata Spinal Fixation System
- Oct 29, 2026SeaSpine Orthopedics Corporation
Convoy Expandable Corpectomy System
- Oct 28, 2026Fziomed, Inc.
Dynavisc
- Oct 28, 2026Evident Vascular, Inc.
Evident Vascular Guidance System
- Oct 27, 2026The Belport Company Inc., DBA Gingi-Pak
AquaVance Clear Fluoride Treatment
- Oct 26, 2026Expanse Medical, Inc.
FLOWRUNNER Aspiration System
- Oct 26, 2026Single Pass, Inc.
SP Electrocautery Device (SP18 Max);SP Electrocautery Device (SP20 Max)
- Oct 22, 2026Cepheid
Xpert Xpress CoV-2/Flu plus
- Oct 21, 2026Beta Bionics, Inc.
Mint ACE Pump
- Oct 21, 2026Alphatec Spine, Inc.
Calibrate MAX System; Calibrate NanoTec MAX System; Calibrate CCX Interbody System; Calibrate NanoTec CCX Interbody System
- Oct 21, 2026Toro Neurovascular, Inc.
Toro 71 Aspiration Catheter; Toro Aspiration Tubing
- Oct 20, 2026Sleepcare, LLC
Daybreak Impression Material
- Oct 20, 2026Bd Biosciences
BD OneFlow LST; BD OneFlow B-CLPD T1; BD FACSLyric Flow Cytometer, 8-color [4-2-2], 10-color [4-3-3], 12-color (4-3-5)
- Oct 19, 2026Linatech, LLC
VenusCT
- Oct 16, 2026Route 92 Medical, Inc.
Route 92 Medical Full Length 046 Reperfusion System and Aspiration Tubing Set
- Oct 16, 2026THINK Surgical, Inc.
TMINI Miniature Robotic System
- Oct 16, 2026Carecubes, Inc.
Carecube Negative Pressure Isolation Chamber (1BY)
- Oct 15, 2026Penumbra, Inc.
INDIGO Aspiration System
- Oct 15, 2026Circadia Health, Inc.
The Circadia CX00 System (CX00)
- Oct 14, 2026Intuitive Surgical, Inc.
da Vinci 5 Handheld Camera Head (470080);da Vinci 5 Handheld Camera Laparoscope, 0 degree (470081);da Vinci 5 Handheld Camera Laparoscope, 30 degree (470082);da Vinci 5 Handheld Camera Tray (400526);da Vinci 5 Firefly Imaging System
- Oct 14, 2026Masimo Corporation
Radius VSM and Accessories
- Oct 11, 2026Endovascular Engineering, Inc.
Helo Return
- Oct 9, 2026Stryker Neurovascular
Excelsior Reach Microcatheter
- Oct 9, 2026Allwin Medical Devices, Inc.
The D-Tip Denudation Pipette
- Oct 7, 2026Vista AI, Inc.
Vista AI Scan
- Oct 6, 2026Okami Medical, Inc.
LOBO Vascular Occlusion System
- Oct 6, 2026Alembic, LLC
APRO 88 Catheter
- Oct 6, 2026True Function Laboratory, Inc.
Forza
- Oct 5, 2026Inkspace Imaging, Inc.
InkSpace Imaging Small Body Array (SBA12PH15x)
- Oct 2, 2026Cepheid
Xpert Xpress CoV-2/Flu plus
- Sep 29, 2026Djo, LLC
Spinalogic Bone Growth Stimulator
- Sep 29, 2026QT Medical, Inc.
QCA 10 Electrocardiograph (QCARD-10); QCA 10W Electrocardiograph (QCARD-10W)
- Sep 25, 2026Align Technology, Inc.
Invisalign System
- Sep 25, 2026Cepheid
Xpert Respiratory Panel
- Sep 25, 2026CapsoVision, Inc.
CapsoView (CVV); CapsoCloud (CLD)
- Sep 25, 2026Life Detection Technologies
DistaSense(TM) (v1)
- Sep 24, 2026Den-Mat Holdings, LLC
MPa Max adhesive
- Sep 24, 2026Carlsmed, Inc.
corra cervical plating system
- Sep 23, 2026Elevation Spine
SABER-C System
- Sep 23, 2026SI-BONE, Inc.
iFuse Granite Onyx Implant System
- Sep 22, 2026Alfa Scientific Designs, Inc.
Instant-View hCG Combo II Cassette Test
- Sep 18, 2026Vantis Vascular, Inc.
CrossFAST Integrated Microcatheter Advanced Delivery System
- Sep 18, 2026Biolinq Incorporated
Biolinq Shine Autonomous Time-in-Range Microsensor
- Sep 18, 2026Neptune Medical, Inc.
Pathfinder Endoscope Overtube
- Sep 18, 2026Inari Medical, Inc.
Triever Duo Catheter
- Sep 17, 2026Paragon Implant Mfg., LLC
TriActive Dental Implant System
- Sep 16, 2026ClearClub
ClearClub Impression Material
- Sep 16, 2026Ceribell, Inc.
Ceribell EEG Analysis Software
- Sep 16, 2026Amptron Medical, Inc.
ElintMAX Respiratory Monitor (ElintMAX Monitor A1)
- Sep 16, 2026Route 92 Medical, Inc.
Route 92 Medical Full Length 046 Access System
- Sep 15, 2026Calyxo, Inc.
CVAC Aspiration System
- Sep 14, 2026Maduro Medical, Inc.
Radical 064 Reperfusion Catheter; Radical 076 Reperfusion Catheter; Radical Aspiration Tubing Kit
- Sep 11, 2026Beta Bionics, Inc.
iLet Dosing Decision Software
- Sep 11, 2026Beta Bionics, Inc.
Mint ACE Pump
- Sep 8, 2026Intuitive Surgical, Inc.
da Vinci Surgical System, Model IS5000
- Sep 8, 2026Emboline, Inc.
Emboliner Embolic Protection System (EPC-03)
- Sep 4, 2026Ortho-Clinical Diagnostics, Inc. (QuidelOrtho)
Sofia 2 SARS Antigen+ FIA; Sofia 2 Lyme FIA
- Sep 4, 2026Ortho Clinical Diagnostics Inc. (QuidelOrtho)
Sofia Influenza A+B FIA; Sofia RSV FIA; Sofia Strep A+ FIA
- Sep 3, 2026Endovascular Engineering
Helo Max Thrombectomy System (HEL2090)
- Sep 3, 2026Neptune Medical, Inc.
Triton 1 System
- Sep 3, 2026MicroVention, Inc., d/b/a Terumo Neuro
Mayumi Thrombectomy System
- Sep 2, 2026Serpex Medical
Maverix Cryo Biopsy Pro (MCB Pro) (MCBP-1000); Maverix Cryo Cartridge (CC-1000)
- Sep 2, 2026Modular Medical, Inc.
Pivot Insulin Delivery System
- Aug 28, 2026Reflow Medical, Inc.
Kiba CTO Crossing Catheter
- Aug 28, 2026Imperative Care, Inc.
Zoom 4S Catheter
- Aug 28, 2026Roche Molecular Systems, Inc.
cobas Strep A Nucleic acid test for use on the cobas Liat System (07341911190); cobas Strep A Quality Control Kit (07402678190)
- Aug 28, 2026Roche Molecular Systems, Inc.
cobas Cdiff Nucleic acid test for use on the cobas Liat System (07454945190); cobas Cdiff Positive and Negative Control Kit for use on the cobas Liat System (07454970190)
- Aug 27, 2026Prismatik Dentalcraft, Inc.
Glidewell Denture Base Resin
- Aug 27, 2026Resmed Corp
EasyCare Tx 2
- Aug 25, 2026Ceevra, Inc.
Ceevra Reveal 4
- Aug 24, 2026Bolt Medical, Inc.
SEISMIQ Intravascular Lithotripsy System
- Aug 21, 2026Inari Medical, Inc.
Artix MT;Artix Thin-Walled Sheath
- Aug 20, 2026Hardy Diagnostics
HardyDisk AST Tebipenem 10µg (TBP10)
- Aug 18, 2026Sight Sciences, Inc.
TearCare System
- Aug 18, 2026AI Planning Logic, Inc.
Lower Limb AI (LLAI)
- Aug 18, 2026Wallaby Medical
p17 XR Microcatheter
- Aug 14, 2026Arbor Endovascular, LLC
Willow 12 Guidewire
- Aug 14, 2026Cerenovus, Inc.
MICRUSFRAME (MFR100202); MICRUSFRAME (MFR100253); MICRUSFRAME (MFR100305); MICRUSFRAME (MFR100356); MICRUSFRAME (MFR100407); MICRUSFRAME (MFR100412); MICRUSFRAME (MFR100509); MICRUSFRAME (MFR100517); MICRUSFRAME (MFR100611); MICRUSFRAME (MFR100626); MICRUSFRAME (MFR100713); MICRUSFRAME (MFR100730); MICRUSFRAME (MFR100816); MICRUSFRAME (MFR100829); MICRUSFRAME (MFR140225); MICRUSFRAME (MFR140303); MICRUSFRAME (MFR140304); MICRUSFRAME (MFR140306); MICRUSFRAME (MFR140406); MICRUSFRAME (MF
- Aug 12, 2026Alembic, LLC
APRO 35 Swift Catheter
- Aug 12, 2026Alembic, LLC
APRO 35 Swift Catheter and Alembic Aspiration Tubing
- Aug 12, 2026TriMed, Inc.
Large Compression Screws
- Aug 12, 2026Cortechs Labs, Inc.
NeuroQuant PET
- Aug 12, 2026Masimo Corporation
Masimo Root Monitoring System
- Aug 11, 2026Dexcom, Inc.
Stelo Glucose Biosensor System
- Aug 10, 2026Nova Eye, Inc.
Nova Eye iTrack 250A Canaloplasty Microcatheter (iTrack 250A)
- Aug 7, 2026The Belport Company Inc., DBA Gingi-Pak
PacTemp Automix NE
- Aug 7, 2026Cepheid
Xpert Hemorrhagic Fever
- Aug 7, 2026Intuitive Surgical, Inc.
Intuitive Endoluminal Gastrointestinal System (IG1000)
- Aug 7, 2026Leica Biosystems Imaging, Inc.
Aperio iQC DX Software
- Aug 7, 2026Leica Biosystems Imaging, Inc.
Aperio GT 450 DX; Aperio GT 180 DX
- Aug 7, 2026Aptitude Medical Systems, Inc.
Metrix COVID Test; Metrix COVID Test Pro
- Aug 4, 2026Jupiter Endovascular
Vertex Thrombectomy System
- Aug 4, 2026Sight Sciences, Inc.
OMNI Ultra Surgical System (1-110)
- Aug 3, 2026Varian Medical Systems, Inc.
Halcyon, Ethos Radiotherapy System (5.0)
- Aug 3, 2026Elevation Spine
SABER-XA System
Source: FDA public records. The K number is in Whimbrel's corpus, and the company, device, state, product code and review panel are the openFDA 510(k) fields for that K number. FDA data through October 30, 2026. Each K number links to the FDA record. openFDA data are not validated by the FDA for medical decisions. Check the FDA record before you rely on a row. openFDA 510(k) API. FDA 510(k) database.
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