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
4561–4584 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Feb 18, 2011
SAFE'N'SOUND PASSIVE DELIVERY SYSTEM
K101233 · MEG
Rexam Pharma
General Hospital · 291d
Cleared Feb 16, 2011
DANA REUSABLE TESTPACK FOR STEAM STERILIZATION FOR 10 MINUTE EXTENDED CYCLES
K103321 · FRC
Dana Products, Inc.
General Hospital · 96d
Cleared Feb 11, 2011
SMART READ BIOLOGICAL TEST PACK
K103000 · JOJ
Steritec Products Mfg Co, Inc.
General Hospital · 126d
Cleared Feb 10, 2011
SWABFLSUH (3ML, 5ML, 10ML) MODEL 10331, 10351, 10311
K101270 · NGT
Excelsior Medical Corp.
General Hospital · 280d
Cleared Feb 09, 2011
VERIFY CHEMICAL MONITORING STRIP FOR RESERT SOULTIONS (RESERT XL TEST STRIP...
K102296 · JOJ
STERIS Corporation
General Hospital · 180d
Cleared Feb 08, 2011
MED-LOK SAFETY NEEDLE
K103781 · MEG
Sta-Med, LLC
General Hospital · 43d
Cleared Feb 04, 2011
BAM STANDARD SURGICAL GOWN, BAM REINFORCED SURGICAL GOWN, BAM ULTRA...
K093835 · FYA
Bam Corp., Ltd.
General Hospital · 416d
Cleared Feb 03, 2011
PATIENT EXAMINATION GLOVES
K102838 · LYY
Thai Hua Holding Co., Ltd.
General Hospital · 127d
Cleared Feb 03, 2011
NON REINFORCED SURGICAL GOWNS, FILM REINFORCED SURGICAL GOWNS, FABRIC...
K102652 · FYA
Gri Medical & Electronic Technology...
General Hospital · 142d
Cleared Feb 02, 2011
FINESS ENDOSCOPE STERILIZATION TRAY
K103213 · KCT
Entellus Medical, Inc.
General Hospital · 93d
Cleared Feb 02, 2011
ULTICARE SAFETY INSULIN SYRINGE
K103011 · MEG
Ulti-Med Intl., Inc.
General Hospital · 113d
Cleared Jan 28, 2011
SENTICARE PILLSTATION
K103009 · NXQ
Senticare, Inc.
General Hospital · 108d
Cleared Jan 28, 2011
STERRAD CYCLESURE 24 BIOLOGICAL INDICATOR
K102884 · FRC
Advanced Sterilization Products
General Hospital · 120d
Cleared Jan 27, 2011
SPSMEDICAL EMPLUS 270 F STEAM EMULATOR MODEL EMP-104, EMP-1004
K102363 · JOJ
Spsmedical Supply Corp.
General Hospital · 160d
Cleared Jan 26, 2011
BRAUN THERMOSCAN PRO 4000 SERIES AND BRAUN THERMOSCAN IRT 4000 SERIES...
K103800 · FLL
Kaz USA, Inc (A Subsidiaryof Kaz Inc)
General Hospital · 29d
Cleared Jan 25, 2011
TIGER FLAT SURGICAL MASK
K102713 · FXX
Tiger Medical Products, Ltd.
General Hospital · 127d
Cleared Jan 21, 2011
INFA WARMER I
K102227 · FMT
Atom Medical Corporation
General Hospital · 165d
Cleared Jan 14, 2011
INFRARED EAR THERMOMETER, MODEL IR-04MT
K102934 · FLL
Vega Technologies, Inc.
General Hospital · 102d
Cleared Jan 14, 2011
84E SERIES SINGLE PLY WRAPPER
K102864 · FRG
Lac Mac, Ltd.
General Hospital · 106d
Cleared Jan 14, 2011
IMC HYPODERMIC NEEDLE
K102584 · FMI
International Medsurg Connection
General Hospital · 128d
Cleared Jan 14, 2011
NORFOLK MEDICAL NORPORT FAMILY OF PORTS
K102385 · LJT
Norfolk Medical Products, Inc.
General Hospital · 144d
Cleared Jan 13, 2011
MEDIVATORS ADVANTAGE PLUS ENDOSCOPE REPROCESSOR
K102996 · FEB
Medivators Reprocessing Systems
General Hospital · 98d
Cleared Jan 13, 2011
SURGIPLUS SMS SURGICAL DRAPE (STERILE/NON-STERILE), SURGIPLUS SPP WITH PE...
K102861 · KKX
A Plus International, Inc.
General Hospital · 105d
Cleared Jan 13, 2011
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K102613 · LYZ
Hebei Favor Plastic Co., Ltd.
General Hospital · 125d