General Hospital FDA 510(k) clearances, last 90 days
US companies with an FDA 510(k) clearance in General Hospital from Aug 2, 2026 to Oct 30, 2026. FDA data through October 30, 2026.
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Last 90 days
21 clearances in the last 90 days. The same 90 days a year earlier: 16.
For contract manufacturers and test labs
General Hospital accounts for 21 US 510(k) clearances in the last 90 days. The product code with the most clearances in this window is FMF (Syringe, Piston). Contract manufacturers and test labs that work on General Hospital devices 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 |
|---|---|---|
FMF | Syringe, Piston | 2 |
FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 2 |
FPA | Set, Administration, Intravascular | 2 |
JOJ | Indicator, Physical/Chemical Sterilization Process | 2 |
LZA | Polymer Patient Examination Glove | 2 |
| Decision date | Company | Device | FDA record |
|---|---|---|---|
| Oct 29, 2026 | STERIS | V-Pro maX 2 Low Temperature Sterilization System | K263530 |
| Oct 28, 2026 | Steris | VERIFY RESI-TEST SWAB Protein Detection Indicator | K260822 |
| Oct 22, 2026 | B.Braun Medical, Inc. | Gravity Blood Sets with 200µm Filter | K260261 |
| Oct 16, 2026 | Ibt Scientific | Endox Test Strips | K263267 |
| Oct 16, 2026 | Carecubes, Inc. | Carecube Negative Pressure Isolation Chamber (1BY) | K260180 |
| Oct 9, 2026 | Medical Components, Inc. | Pro-Line XL Power Injectable Central Venous Catheter and Pro-Line XL Tunneler | K260080 |
| Sep 25, 2026 | Solventum US, LLC | 3M Attest Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES) | K261992 |
| Sep 18, 2026 | ICU Medical | NORMOFLO Irrigation Fluid Warming Sets and Accessories (IR-601, IR-501, IR-61, PL-61) | K262532 |
| Sep 18, 2026 | Martech Medical Products | 25G Huber Needle | K254095 |
| Sep 11, 2026 | Ecomed Solutions, LLC | Ecomed Disposable Administration Sets | K254123 |
| Sep 9, 2026 | Maxter Healthcare, Inc. | Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs and Fentanyl Citrate (Blue and Black Color) | K261793 |
| Sep 4, 2026 | Dentsply Sirona, Inc. | Surgical and Prosthetic Trays | K261935 |
| Sep 2, 2026 | Modular Medical, Inc. | Pivot Insulin Delivery System | K262153 |
| Sep 2, 2026 | Cardinalhealth | Cardinal Health Nitrile Blue Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | K261749 |
| Sep 2, 2026 | Venocare, Inc. | Ruby Intravascular Catheter | K260432 |
| Aug 31, 2026 | Global Life Sciences Solutions USA, LLC | Lipipor NLF1A Infusion Filter, Lipipor NLF2A & NLF2NTA Infusion Filters, Lipipor TNA2A Infusion Filter | K261403 |
| Aug 26, 2026 | SurGenTec, LLC | GraftGun Universal Graft Delivery System (GDS) | K262581 |
| Aug 25, 2026 | Sol-Millennium Medical, Inc. | SOL-M Luer Lock Syringe with Exchangeable Needle Tray | K252184 |
| Aug 10, 2026 | Hh Global Technology, Inc. | Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety Type IIIB, Safety Type IV, Safety Type V, Ordinary Type VIA, Ordinary Type VIB, Ordinary Type VIC, Safety Type VII, Ordinary Type IB, Safety type VIII, Safety Type IX, Safety Type X, Ordinary Type XI, Safety Type XII) | K262427 |
| Aug 10, 2026 | Spectrum Vascular | Unimpregnated Central Venous Catheter | K260165 |
| Aug 4, 2026 | Sight Sciences, Inc. | OMNI Ultra Surgical System (1-110) | K253760 |
- Oct 29, 2026STERIS
V-Pro maX 2 Low Temperature Sterilization System
- Oct 28, 2026Steris
VERIFY RESI-TEST SWAB Protein Detection Indicator
- Oct 22, 2026B.Braun Medical, Inc.
Gravity Blood Sets with 200µm Filter
- Oct 16, 2026Ibt Scientific
Endox Test Strips
- Oct 16, 2026Carecubes, Inc.
Carecube Negative Pressure Isolation Chamber (1BY)
- Oct 9, 2026Medical Components, Inc.
Pro-Line XL Power Injectable Central Venous Catheter and Pro-Line XL Tunneler
- Sep 25, 2026Solventum US, LLC
3M Attest Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES)
- Sep 18, 2026ICU Medical
NORMOFLO Irrigation Fluid Warming Sets and Accessories (IR-601, IR-501, IR-61, PL-61)
- Sep 18, 2026Martech Medical Products
25G Huber Needle
- Sep 11, 2026Ecomed Solutions, LLC
Ecomed Disposable Administration Sets
- Sep 9, 2026Maxter Healthcare, Inc.
Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs and Fentanyl Citrate (Blue and Black Color)
- Sep 4, 2026Dentsply Sirona, Inc.
Surgical and Prosthetic Trays
- Sep 2, 2026Modular Medical, Inc.
Pivot Insulin Delivery System
- Sep 2, 2026Cardinalhealth
Cardinal Health Nitrile Blue Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
- Sep 2, 2026Venocare, Inc.
Ruby Intravascular Catheter
- Aug 31, 2026Global Life Sciences Solutions USA, LLC
Lipipor NLF1A Infusion Filter, Lipipor NLF2A & NLF2NTA Infusion Filters, Lipipor TNA2A Infusion Filter
- Aug 26, 2026SurGenTec, LLC
GraftGun Universal Graft Delivery System (GDS)
- Aug 25, 2026Sol-Millennium Medical, Inc.
SOL-M Luer Lock Syringe with Exchangeable Needle Tray
- Aug 10, 2026Hh Global Technology, Inc.
Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety Type IIIB, Safety Type IV, Safety Type V, Ordinary Type VIA, Ordinary Type VIB, Ordinary Type VIC, Safety Type VII, Ordinary Type IB, Safety type VIII, Safety Type IX, Safety Type X, Ordinary Type XI, Safety Type XII)
- Aug 10, 2026Spectrum Vascular
Unimpregnated Central Venous Catheter
- Aug 4, 2026Sight Sciences, Inc.
OMNI Ultra Surgical System (1-110)
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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