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Pennsylvania FDA 510(k) clearances, last 90 days

US companies with an FDA 510(k) clearance and a Pennsylvania address from Aug 2, 2026 to Oct 30, 2026. FDA data through October 30, 2026.

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Last 90 days

28 clearances in the last 90 days. The same 90 days a year earlier: 18.

For contract manufacturers and test labs

Pennsylvania had 28 US 510(k) clearances in the last 90 days and 90 in the last 12 months. The product code with the most clearances in this window is HRS (Plate, Fixation, Bone). Contract manufacturers and test labs that sell to device companies in Pennsylvania 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 codeDevice typeClearances
HRSPlate, Fixation, Bone3
BZDVentilator, Non-Continuous (Respirator)1
DXTInjector And Syringe, Angiographic1
FPASet, Administration, Intravascular1
FTLMesh, Surgical, Polymeric1
28 clearances, Aug 2, 2026 to Oct 30, 2026.
Decision dateCompanyDeviceFDA record
Oct 30, 2026Dentsply Sirona, Inc.DS Core DetectK261072
Oct 30, 2026Airgas Therapeutics, LLCULSPIRA TS™ Nitric Oxide Therapy SystemK253095
Oct 29, 2026Maxx Orthopedics, Inc.Libertas Acetabular Liners (Acetabular Liner)K260975
Oct 27, 2026Cryoconcepts LPSkin Clinic Nitro Clear for Warts and Skin TagsK260520
Oct 23, 2026Pace SurgicalTempo Plating SystemK263407
Oct 23, 2026Globus Medical, Inc.ANTHEM™ Fracture SystemK262779
Oct 22, 2026B.Braun Medical, Inc.Gravity Blood Sets with 200µm FilterK260261
Oct 9, 2026Medical Components, Inc.Pro-Line XL Power Injectable Central Venous Catheter and Pro-Line XL TunnelerK260080
Oct 7, 2026Centinel Spine, LLCprodisc C; prodisc C SK; prodisc C Nova; prodisc C Vivo InstrumentsK263159
Oct 6, 2026Bayer Medical Care, Inc.MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD IS12 Module (IS12); MEDRAD Imaging Bulk Package Transfer SpikeK262043
Oct 2, 2026Aesculap, Inc.Ventricular Catheters, Thomale CatheterK260044
Sep 28, 2026TELA Bio, Inc.Liora Monofilament ScaffoldK260474
Sep 25, 2026Respironics, Inc.Altis Full Face MaskK261262
Sep 18, 2026VacHeal, LLCVacHeal Negative Pressure Wound Therapy SystemK254160
Sep 18, 2026Martech Medical Products25G Huber NeedleK254095
Sep 11, 2026Curvebeam AI / Curvebeam, LLCBoneVueK254072
Sep 10, 2026B.Braun Medical, Inc.Irrigation/Urology SetsK254111
Sep 4, 2026Dentsply Sirona, Inc.Surgical and Prosthetic TraysK261935
Sep 3, 2026Pace SurgicalTempo Plating System; Ultra Compression Screw SystemK261647
Sep 2, 2026Aevumed, Inc.Aevumed SUPERCYNCH™ Button SystemK253065
Aug 31, 2026Siemens Medical Solutions USA, Inc.MULTIX Impact; MULTIX Impact CK260488
Aug 28, 2026X-Nav Technologies, LLCX-Guide Surgical Navigation SystemK253954
Aug 24, 2026Flower Orthopedics Corporation DBA Conventus Flower OrthopedOsteoCoil™ GT Active Compression SystemK260106
Aug 21, 2026Dentsply SironaDS Core CBCT AnatomyK262127
Aug 14, 2026Boehringer Laboratories, LLC52Fr ViSiGi LUX™; 52Fr ViSiGi 3DK261890
  • Oct 30, 2026
    Dentsply Sirona, Inc.

    DS Core Detect

    K261072
  • Oct 30, 2026
    Airgas Therapeutics, LLC

    ULSPIRA TS™ Nitric Oxide Therapy System

    K253095
  • Oct 29, 2026
    Maxx Orthopedics, Inc.

    Libertas Acetabular Liners (Acetabular Liner)

    K260975
  • Oct 27, 2026
    Cryoconcepts LP

    Skin Clinic Nitro Clear for Warts and Skin Tags

    K260520
  • Oct 23, 2026
    Pace Surgical

    Tempo Plating System

    K263407
  • Oct 23, 2026
    Globus Medical, Inc.

    ANTHEM™ Fracture System

    K262779
  • Oct 22, 2026
    B.Braun Medical, Inc.

    Gravity Blood Sets with 200µm Filter

    K260261
  • Oct 9, 2026
    Medical Components, Inc.

    Pro-Line XL Power Injectable Central Venous Catheter and Pro-Line XL Tunneler

    K260080
  • Oct 7, 2026
    Centinel Spine, LLC

    prodisc C; prodisc C SK; prodisc C Nova; prodisc C Vivo Instruments

    K263159
  • Oct 6, 2026
    Bayer Medical Care, Inc.

    MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD IS12 Module (IS12); MEDRAD Imaging Bulk Package Transfer Spike

    K262043
  • Oct 2, 2026
    Aesculap, Inc.

    Ventricular Catheters, Thomale Catheter

    K260044
  • Sep 28, 2026
    TELA Bio, Inc.

    Liora Monofilament Scaffold

    K260474
  • Sep 25, 2026
    Respironics, Inc.

    Altis Full Face Mask

    K261262
  • Sep 18, 2026
    VacHeal, LLC

    VacHeal Negative Pressure Wound Therapy System

    K254160
  • Sep 18, 2026
    Martech Medical Products

    25G Huber Needle

    K254095
  • Sep 11, 2026
    Curvebeam AI / Curvebeam, LLC

    BoneVue

    K254072
  • Sep 10, 2026
    B.Braun Medical, Inc.

    Irrigation/Urology Sets

    K254111
  • Sep 4, 2026
    Dentsply Sirona, Inc.

    Surgical and Prosthetic Trays

    K261935
  • Sep 3, 2026
    Pace Surgical

    Tempo Plating System; Ultra Compression Screw System

    K261647
  • Sep 2, 2026
    Aevumed, Inc.

    Aevumed SUPERCYNCH™ Button System

    K253065
  • Aug 31, 2026
    Siemens Medical Solutions USA, Inc.

    MULTIX Impact; MULTIX Impact C

    K260488
  • Aug 28, 2026
    X-Nav Technologies, LLC

    X-Guide Surgical Navigation System

    K253954
  • Aug 24, 2026
    Flower Orthopedics Corporation DBA Conventus Flower Orthoped

    OsteoCoil™ GT Active Compression System

    K260106
  • Aug 21, 2026
    Dentsply Sirona

    DS Core CBCT Anatomy

    K262127
  • Aug 14, 2026
    Boehringer Laboratories, LLC

    52Fr ViSiGi LUX™; 52Fr ViSiGi 3D

    K261890

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.

FAQ

Is a 510(k) an FDA approval?
No. The FDA clears a device through a 510(k) when it finds the device substantially equivalent to one already sold in the US.
Where do these rows come from?
From openFDA's 510(k) records, for K numbers Whimbrel already holds. Each K number links to the FDA 510(k) database.
Which states get a page?
A state page is published when the state has 10 or more US clearances in the last 12 months and 10 or more in the last 90 days.

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