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
4849–4872 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Apr 05, 2010
MEDIVATORS DSD EDGE ENDOSCOPE REPROCESSING SYSTEM
K092387 · FEB
Minntech Corp.
General Hospital · 243d
Cleared Apr 05, 2010
SYSTEM 1.5 STERILE PROCESSING SYSTEM
K090036 · MED
STERIS Corporation
General Hospital · 454d
Cleared Apr 02, 2010
PRIMUS STEAM STERILIZER PSS8-AA (16X16X26 MULTI FUNCTIONAL STERILIZER),...
K093333 · FLE
Primus Sterilizer Company, LLC
General Hospital · 158d
Cleared Apr 01, 2010
1ML UNITRACT INSULIN SYRINGE 27G X 1/2 AND 29G X 1/2
K093400 · FMF
Unilife Medical Solutions Limited
General Hospital · 150d
Cleared Mar 29, 2010
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K100337 · LYZ
Tangshan Qixin Glove Co., Ltd.
General Hospital · 55d
Cleared Mar 29, 2010
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K100324 · LYZ
Tangshan Hengtong Plastic Products Co.
General Hospital · 53d
Cleared Mar 25, 2010
MORPHEUS SMART PICC CT AND PROCEDURE KIT MODEL 12105509, 12105519
K093406 · LJS
AngioDynamics, Inc.
General Hospital · 143d
Cleared Mar 25, 2010
CODMAN STERILIZATION CONTAINERS
K092437 · KCT
Codman & Shurtleff, Inc.
General Hospital · 230d
Cleared Mar 24, 2010
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K100326 · LYZ
Tangshan Hongda Plastci Products Co,...
General Hospital · 48d
Cleared Mar 24, 2010
MULTIPLE PRIVATE LABEL
K100162 · LZA
Biogreen Yields Sdn.Bhd
General Hospital · 63d
Cleared Mar 24, 2010
EXTENDED USE ALDAHOL HIGH LEVEL DISINFECTANT
K091890 · MED
Healthpoint, Ltd.
General Hospital · 274d
Cleared Mar 22, 2010
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K100339 · LYZ
Tangshan Changrong Glove Co., Ltd.
General Hospital · 45d
Cleared Mar 19, 2010
KIMBERLY-CLARK KC100 SURGICAL GOWN, MODEL KC100
K093115 · FYA
Kimberly-Clark Corp.
General Hospital · 168d
Cleared Mar 18, 2010
WIRELESS BODY TEMPERATURE MONITOR MODEL BTM-DIX SERIES (BTM-DIC,D,E,F,G & H)
K100226 · FLL
Rio Flexon Technology Co., Ltd.
General Hospital · 52d
Cleared Mar 18, 2010
DANA REUSABLE TEST PACK FOR STEAM STERILIZATION
K092944 · FRC
Dana Products, Inc.
General Hospital · 175d
Cleared Mar 12, 2010
ACTHERM INFRARED EAR THERMOMETER ACT 8000R SERIES AND ITS PROBE COVER MED...
K093795 · FLL
Actherm, Inc.
General Hospital · 92d
Cleared Mar 12, 2010
COAXIAL APPLICATOR SYSTEM
K091722 · FMF
Biomet, Inc.
General Hospital · 274d
Cleared Mar 10, 2010
AMSINO I.V. ADMINISTRATION SET, AMSAFE3 I.V ADMINISTRATION SET, EXTENSION SETS
K093773 · FPA
Amsino International, Inc.
General Hospital · 92d
Cleared Mar 10, 2010
NEXUS INTRAVASCULAR TUBING SETS-PRE-PIERCED
K092930 · FPA
Nexus Medical, LLC
General Hospital · 169d
Cleared Mar 10, 2010
NEOMED STERILE SYRINGE, MODELS SD-S1EO, SD-S3EO, SD-S630, SD-S12EO, SD-S20EO,...
K092908 · FMF
Neomed, Inc.
General Hospital · 169d
Cleared Mar 10, 2010
CONMED DETACHATIP INSTRUMENT TRAY, 33CM AND 43CM
K092414 · KCT
Conmed Corporation
General Hospital · 215d
Cleared Mar 10, 2010
HYDRO-GUARD MINI BREATHING FILTER AND HEAT AND MOISTURE EXCHANGER AND...
K092409 · CAH
Intersurgical, Inc.
General Hospital · 216d
Cleared Mar 05, 2010
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW)
K100058 · LYZ
Tangshan Zhongpu Plastic Products...
General Hospital · 56d
Cleared Mar 04, 2010
AVITA SCANEO INFRARED EAR THERMOMETER, MODEL TS7
K100016 · FLL
Avita Corporation
General Hospital · 59d