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
5161–5184 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Feb 26, 2009
FORA IR22 EAR THERMOMETER, MODEL TD-1262
K090294 · FLL
Taidoc Technology Corporation
General Hospital · 21d
Cleared Feb 26, 2009
BUSSE SURGICAL DRAPE
K083424 · KKX
Busse Hosipital Disposables
General Hospital · 99d
Cleared Feb 26, 2009
PHARMAJET NEEDLE-FREE INJECTION SYSTEM
K081532 · KZE
Pharmajet, Inc.
General Hospital · 269d
Cleared Feb 25, 2009
ICU MEDICAL UNIVERSAL SINGLE-USE SPIKES
K082836 · FMG
Icu Medical, Inc.
General Hospital · 152d
Cleared Feb 20, 2009
EVICEL APPLICATION DEVICE
K090162 · FMF
Omrix Biopharmaceuticals , Ltd.
General Hospital · 29d
Cleared Feb 20, 2009
FREESTYLE AVIATOR INSULIN DELIVERY AND BLOOD GLUCOSE MONITORING SYSTEM
K083225 · LZG
Abbott Diabetes Care, Inc.
General Hospital · 109d
Cleared Feb 19, 2009
VINYL EXAMINATION GLOVE, POWDER-FREE, CLEAR (NON-COLORED)
K083600 · LYZ
Quantum Co., Ltd.
General Hospital · 76d
Cleared Feb 17, 2009
PATIENT VINYL EXAMINATION GLOVES, POWDERFREE, NON-STERILE
K083259 · LYZ
Tangshan Zhongying Plastic Products...
General Hospital · 105d
Cleared Feb 13, 2009
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K090016 · LYZ
Suqian Clean Glove Co., Ltd.
General Hospital · 42d
Cleared Feb 13, 2009
TACTIPEN
K083457 · FMF
Haselmeier GmbH
General Hospital · 84d
Cleared Feb 13, 2009
REVAC AUTO RETRACTABLE SAFETY SYRINGE
K083193 · FMF
Revolutions Medical Corporation, Inc.
General Hospital · 107d
Cleared Feb 13, 2009
MEDIVATORS ADVANTAGE PLUS ENDOSCOPE REPROCESSING SYSTEM, RAPICIDE PA HIGH...
K082988 · FEB
Medivators Reprocessing Systems
General Hospital · 129d
Cleared Feb 13, 2009
FLU-ADMIN, MODELS 60150, 60150C, 60151C, 60153C, 60160
K082027 · FPA
Genesis Bps, LLC
General Hospital · 211d
Cleared Feb 13, 2009
STATSTRAP NEONATAL INCUBATOR SAFETY STRAP, MODELS SS-001, SS-002
K081264 · FMQ
Children'S Health First, Inc.
General Hospital · 284d
Cleared Feb 12, 2009
BELMONT HYPERTHERMIA PUMP
K090089 · LGZ
Belmont Instrument Corp.
General Hospital · 29d
Cleared Feb 12, 2009
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K083047 · LYZ
Zibo Wanci Plastic & Rubber Co., Ltd.
General Hospital · 121d
Cleared Feb 11, 2009
NEO MAPCATH SENSOR STYLET
K083121 · OMF
Corpak Medsystems
General Hospital · 112d
Cleared Feb 10, 2009
POWDER FREE NITRILE (BLUE AND WHITE) EXAMINATION GLOVES
K083624 · LZA
Comfort Rubber Gloves Ind. Sdn. Bhd.
General Hospital · 64d
Cleared Feb 10, 2009
N-DEX BWC PINK NITRILE MEDICAL EXAMINATION GLOVE, NON STERILE
K082428 · LZA
Best Glove, Inc.
General Hospital · 172d
Cleared Feb 09, 2009
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K082690 · LYZ
Hebei Handform Plastic Products Co.,...
General Hospital · 147d
Cleared Feb 05, 2009
NUOVOGUARD
K090122 · FOZ
U.S. Safety Syringes Co., Inc.
General Hospital · 15d
Cleared Feb 04, 2009
POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K082691 · LYZ
Hebei Handform Plastic Products Co.,...
General Hospital · 142d
Cleared Feb 03, 2009
AIDERA DIASEND
K083221 · MRZ
Aidera AB
General Hospital · 95d
Cleared Feb 02, 2009
EQUASHIELD SYSTEM
K083152 · LHI
Plastmed, Ltd.
General Hospital · 101d