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
3961–3984 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Feb 27, 2013
ESOTEST ESOPHAGEAL TEMPERATURE PROBE AND TEMPERATURE MONITORING SYSTEM
K123361 · FLL
Fiab Spa
General Hospital · 119d
Cleared Feb 27, 2013
DANA REUSABLE BOWIE TEST PACK FOR DANA BOWIE DICK INDICATORS
K120592 · JOJ
Dana Products, Inc.
General Hospital · 365d
Cleared Feb 22, 2013
BLUE STERILE POWDER FREE NITRILE EXAMINATION GLOVE
K122727 · LZA
Northstar Healthcare Holdings
General Hospital · 170d
Cleared Feb 22, 2013
T:CONNECT DATA MANAGEMENT SYSTEM
K122361 · OUG
Tandem Diabetes Care, Inc.
General Hospital · 203d
Cleared Feb 21, 2013
POWDER-FREE NITRILE EXAMINATION GLOVES, BLUE
K130038 · LZA
Hl Rubber Industries Sdn Bhd
General Hospital · 45d
Cleared Feb 21, 2013
DETACHATIP III PLUS INSTRUMENT TRAY MODEL 3-4343
K123175 · KCT
Conmed Corporation
General Hospital · 135d
Cleared Feb 19, 2013
INTRADERMAL ADAPTER
K123588 · FMF
West Pharmaceutical Services, Inc.
General Hospital · 90d
Cleared Feb 19, 2013
POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE AND WHITE COLORED,...
K123469 · LZA
Wear Safe (Malaysia) Sdn Bhd -...
General Hospital · 98d
Cleared Feb 14, 2013
MONOJECT 12ML SYRINGE
K130049 · FMF
Nipro Medical Corporation
General Hospital · 37d
Cleared Feb 14, 2013
SURGICAL DRAPE WITH AAMI LIQUID BARRIER LEVEL IV
K121919 · KKX
Exact Medical Manufacturing, Inc.
General Hospital · 227d
Cleared Feb 11, 2013
CHLORINATED POWDER FREE NITRILE EXAMINATION GLOVES (BLACK COLOUR)
K123116 · LZA
Worldmed Manufacturing Sdn. Bhd.
General Hospital · 131d
Cleared Feb 11, 2013
3M VFLEX HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK
K121069 · MSH
3M Company
General Hospital · 308d
Cleared Feb 08, 2013
LINSHI NITRILE DISPOSABLE EXAM GLOVES, POWDER-FREE
K123488 · LZA
Puyang Linshi Health Co., Ltd.
General Hospital · 87d
Cleared Feb 08, 2013
MYOSURE INTRUMENT TRAY
K121280 · KCT
Hologic, Inc.
General Hospital · 284d
Cleared Feb 07, 2013
0.9% SODIUM CHLORIDE INJECTION USP BD POSIFLUSH FLUSH SYRINGE, SF FLUSH SYRINGE
K121050 · NGT
Becton, Dickinson & CO
General Hospital · 307d
Cleared Feb 05, 2013
GIRAFFE AND PANDA WARMERS
K123309 · FMT
Ohmeda Medical
General Hospital · 104d
Cleared Feb 05, 2013
DIGITAL THERMOMTER
K122520 · FLL
Taidoc Technology Corporation
General Hospital · 172d
Cleared Feb 01, 2013
POWDER FREE LATEX PATIENT EXAMINATION GLOVES, WITH PROTEIN CONTENT LABELING...
K123757 · LYY
Assurguard Sdn. Bhd.
General Hospital · 56d
Cleared Feb 01, 2013
CADD SOLIS VIP AMBULATORY INFUSION PUMP AND CADD SOLIS MEDICATION SAFETY...
K111275 · FRN
Smiths Medical Asd, Inc.
General Hospital · 637d
Cleared Jan 31, 2013
POWDER-FREE NITRILE EXAMINATION GLOVES (COOL BLUE)
K122696 · LZA
Cardinal Health, Inc.
General Hospital · 149d
Cleared Jan 31, 2013
POWERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K122396 · LYZ
Wealth on (Jiangsu) Co., Ltd.
General Hospital · 177d
Cleared Jan 31, 2013
GEMINI STERILZATION WRAP
K113353 · FRG
Medline Industries, Inc.
General Hospital · 444d
Cleared Jan 28, 2013
MULTIPLE NAME
K123760 · LZA
Assurguard Sdn. Bhd.
General Hospital · 52d
Cleared Jan 25, 2013
SYSTEM 83 PLUS
K122172 · FEB
Custom Ultrasonics
General Hospital · 186d