FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: General Hospital ×
17,791 results
289–312 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Feb 28, 2025
Intravascular Extension Sets and Accessories
K242339 · FPA
Baxter Healthcare Corporation
General Hospital · 205d
Cleared Feb 27, 2025
PIVO™ Pro Needle-free Blood Collection Device
K241586 · JKA
Becton Dickinson Infusion Therapy...
General Hospital · 269d
Cleared Feb 26, 2025
Medline Level 4 Surgical Gown with Breathable Sleeves
K242844 · FYA
Medline Industries, LP
General Hospital · 159d
Cleared Feb 24, 2025
Powder Free Nitrile Examination Gloves (Violet, Black, Green), Tested for Use...
K243959 · LZC
Lingshi Hongruida Health Protection...
General Hospital · 63d
Cleared Feb 24, 2025
Sterilization Package/Reel
K241565 · FRG
Anqing Clean Dental Instrument...
General Hospital · 269d
Cleared Feb 21, 2025
Medicom Sterilization Pouch and Reel
K243431 · FRG
Medicom Asia-Pacific Holdings Ltd....
General Hospital · 108d
Cleared Feb 21, 2025
Sterilization Pouches and Reels
K242898 · FRG
Shanghai Jianzhong Medical Packaging...
General Hospital · 151d
Cleared Feb 20, 2025
Green Card Bowie-Dick Test (BD115)
K250172 · JOJ
Steritec Products, Inc. (A Getinge...
General Hospital · 30d
Cleared Feb 19, 2025
Microdent Sterilization Cassette
K242023 · KCT
Implant Microdent System S.L.U.
General Hospital · 223d
Cleared Feb 18, 2025
Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs,...
K243792 · LZA
Basic Medical Technology, Inc.
General Hospital · 70d
Cleared Feb 14, 2025
Non-contact Forehead Infrared Thermometer (FC-IR2000, FC-IR205, FC-IR202,...
K243136 · FLL
Shenzhen Finicare Co., Ltd.
General Hospital · 137d
Cleared Feb 13, 2025
Body Temperature Software (BTS)
K243778 · QZA
Fitbit, LLC
General Hospital · 66d
Cleared Feb 11, 2025
NUVENTUS NV.C™ Surgical Cassette and Tray
K243317 · KCT
Infinitum Eta, Ltd.
General Hospital · 112d
Cleared Feb 06, 2025
Celerity Incubator
K250061 · FRC
STERIS Corporation
General Hospital · 27d
Cleared Feb 06, 2025
Celerity 5 HP Biological Indicator (LCB052)
K250044 · FRC
STERIS Corporation
General Hospital · 27d
Cleared Feb 06, 2025
Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use...
K244034 · LZA
Ever Global (Vietnam) Enterprise...
General Hospital · 38d
Cleared Jan 31, 2025
Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs,...
K243441 · LZA
Basic Medical Technology, Inc.
General Hospital · 86d
Cleared Jan 28, 2025
3M™ Attest™ Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE
K243501 · FRC
3M Company
General Hospital · 77d
Cleared Jan 22, 2025
Rio™ Drug Reconstitution Transfer Device
K243985 · LHI
Icu Medical, Inc.
General Hospital · 30d
Cleared Jan 22, 2025
ZeroClear™ Bag Access (423100)
K243976 · ONB
Epic Medical Pte. , Ltd.
General Hospital · 30d
Cleared Jan 17, 2025
HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit...
K243941 · LJS
Access Vascular, Inc.
General Hospital · 28d
Cleared Jan 17, 2025
Babyroo TN300
K243606 · FMT
Draeger Medical Systems, Inc.
General Hospital · 57d
Cleared Jan 17, 2025
Type 5 Integrating Indicator for Steam (CSPN-15)
K242860 · JOJ
True Indicating, LLC
General Hospital · 119d
Cleared Jan 16, 2025
System 9 Sterile Battery Container
K242834 · KCT
Stryker Instruments
General Hospital · 119d