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
5137–5160 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Mar 27, 2009
KIMGUARD ONE-STEP STERILIZATION WRAP
K082177 · FRG
Kimberly-Clark Corp.
General Hospital · 238d
Cleared Mar 25, 2009
KIMBERLY-CLARK KC100 SURGICAL DRAPES, MODEL KC 100, KIMBERLY-CLARK KC100...
K083234 · KKX
Kimberly-Clark Corp.
General Hospital · 142d
Cleared Mar 23, 2009
PHASEAL PROTECTOR P14, P21, P28 AND P50
K090634 · LHI
Carmel Pharma Ab.
General Hospital · 14d
Cleared Mar 20, 2009
STERILE SODIUM CHLORIDE 0.9% FLUSH, 5ML, 10ML, AMPULE
K082689 · NGT
Spectra Medical Devices, Inc.
General Hospital · 186d
Cleared Mar 19, 2009
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K090537 · LYZ
Tangshan Jiteng Plastic Products Co.,...
General Hospital · 20d
Cleared Mar 19, 2009
PICC (CT RATED AND NON-RATED)
K083873 · LJS
Pfm Medical, Inc.
General Hospital · 80d
Cleared Mar 18, 2009
SMITH & NEPHEW INSTRUMENT TRAYS
K090562 · KCT
Smith & Nephew, Inc.
General Hospital · 16d
Cleared Mar 16, 2009
VERIFY SELF-CONTAINED BIOLOGICAL INDICATOR FOR VAPORIZED (VH2O2)...
K090514 · FRC
STERIS Corporation
General Hospital · 18d
Cleared Mar 16, 2009
ZEUS CT PICC 4 FR AND 5 FR SINGLE AND DUAL LUMEN
K083763 · LJS
R4 Vascular, Inc.
General Hospital · 88d
Cleared Mar 16, 2009
SERIM DISINTEK GTA 2.1%, MODEL: 5164
K083295 · JOJ
Serim Research Corp.
General Hospital · 126d
Cleared Mar 12, 2009
SUPERCATH 5
K081953 · FOZ
Togo Medikit Co., Ltd.
General Hospital · 246d
Cleared Mar 11, 2009
CADI SMARTSENSE VITAL SIGNS AND WIRELESS TEMPERATURE MONITORI NG SYSTEM,...
K083185 · FLL
Cadi Scientific Pte.Ltd
General Hospital · 133d
Cleared Mar 11, 2009
BIOCLEAN CHEMO SHIELD
K081970 · LZA
Nitritex (M) Sdn. Bhd.
General Hospital · 244d
Cleared Mar 10, 2009
NOVA SAFE SCALP VEIN BLOOD COLLECTION SET
K090502 · FOZ
U.S. Safety Syringes Co., Inc.
General Hospital · 13d
Cleared Mar 10, 2009
FORA IR20B EAR THERMOMETER, MODEL TD-1261F, FORA IR21B EAR THERMOMETER, MODEL...
K090395 · FLL
Taidoc Technology Corporation
General Hospital · 21d
Cleared Mar 10, 2009
LOUSEBUSTER
K083206 · LJL
Larada Sciences
General Hospital · 130d
Cleared Mar 10, 2009
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K083015 · LYZ
Zibo Goldenline Plastic Product Co.,...
General Hospital · 152d
Cleared Mar 06, 2009
BLACK NITRILE EXAMINATION GLOVES
K083908 · LZA
Innovative Gloves Co;, Ltd.
General Hospital · 66d
Cleared Mar 06, 2009
DUKAL SURGICAL DRAPE
K083320 · KKX
Dukal Corp.
General Hospital · 114d
Cleared Mar 05, 2009
NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, LAVENDER BLUE COLOR,...
K083755 · LZA
Siam Sempermed Corp., Ltd.
General Hospital · 78d
Cleared Mar 05, 2009
EMU-GRAPH 4 EMULATOR, MODEL CI 144
K083650 · JOJ
Steritec Products, Inc.
General Hospital · 86d
Cleared Mar 04, 2009
MODIFICATION TO SECURACATH, MODEL: SPK01
K083081 · OKC
Interrad Medical, Inc.
General Hospital · 139d
Cleared Mar 03, 2009
ENVIRO SHARP SOLUTIONS 3
K083511 · MMK
Industrial Water Solutions, Inc.
General Hospital · 97d
Cleared Feb 27, 2009
MEDILED PHOTOTHERAPY LAMP
K083179 · LBI
Medix I.C.S.A.
General Hospital · 122d