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
4225–4248 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Apr 12, 2012
BILI-THERAPY PAD TYPE
K111547 · LBI
Atom Medical Corporation
General Hospital · 314d
Cleared Apr 11, 2012
INFUSITE NEEDLELESS ACCES DEVICE (STERILE, BULK NON-STERILE) AND INFUSITE...
K112073 · FPA
Rx Devices, LLC
General Hospital · 266d
Cleared Apr 10, 2012
STERILE LUBRICATING JELLY
K112110 · KMJ
Jianerkang Medical Dressing Company
General Hospital · 263d
Cleared Apr 10, 2012
FINESSE PERSONAL INSULIN DELIVERY PATCH
K111924 · OPP
Calibra Medical, Inc.
General Hospital · 279d
Cleared Apr 05, 2012
STEAM DOT BLU PROCESS INDICATOR
K111453 · JOJ
Propper Mfg. Co., Inc.
General Hospital · 316d
Cleared Apr 02, 2012
DISPOSABLE POWDER FREE VINYL EXAM GLOVE, BLUE COLOR
K120190 · LYZ
Rich Mountain Medical Products, Inc.
General Hospital · 70d
Cleared Mar 30, 2012
ARISURE NEUTRAL VALVE
K120799 · FPA
Yukon Medical, LLC
General Hospital · 14d
Not Cleared Mar 30, 2012
SYSTEM 1E PROCESS BIOLOGICAL MONITORING KIT
DEN110002 · OVY
STERIS Corporation
General Hospital · 242d
Cleared Mar 29, 2012
MEDTRONIC MINIMED PARADIGM INSULIN PUMPS
K120206 · LZG
Medtronic Minimed
General Hospital · 66d
Cleared Mar 29, 2012
POWDERED LATEX SURGICAL GLOVES STERILE, STERILE WITH PROTEIN CONTENT LABELING...
K113233 · KGO
Shen Wei (Usa), Inc.
General Hospital · 148d
Cleared Mar 29, 2012
IMPERIAL SURGICAL LTD. BLANKEY AND SOLUTION WARNING CABINETS
K112702 · LGZ
Imperial Surgical , Ltd.
General Hospital · 195d
Cleared Mar 29, 2012
INFRARED EAR THEROMETER
K111703 · FLL
Fudakang Industrial Co., Ltd.
General Hospital · 286d
Cleared Mar 28, 2012
BD RECYKLEEN SHARPS COLLECTORS
K112774 · MMK
Becton, Dickinson and Company
General Hospital · 187d
Cleared Mar 27, 2012
WOUND PROTECTOR
K120061 · GCJ
Covidien, Formerly US Surgical A...
General Hospital · 78d
Cleared Mar 26, 2012
ALARIS PC UNIT MODULE 8000 WITH SOFTWARE CORRECTION
K110535 · FRN
Carefusion 303, Inc.
General Hospital · 395d
Cleared Mar 21, 2012
POSEY BED
K113357 · OYS
J. T. Posey Co.
General Hospital · 128d
Cleared Mar 21, 2012
NON-STERILE, POWDER-FREE BLUE, NITRILE EXAMINATION GLOVES
K112012 · LZA
Ug Healthcare (Usa), Inc.
General Hospital · 252d
Cleared Mar 21, 2012
NON-STERILE, POWDER-FREE, GREEN LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT...
K112005 · LYY
Ug Healthcare (Usa), Inc.
General Hospital · 252d
Cleared Mar 21, 2012
HEITER 3000 HYPERTHERMIC PERFUSION SYSTEM
K102900 · LGZ
Hei, Inc.
General Hospital · 538d
Cleared Mar 19, 2012
THE SHERLOCK 3CG TIP CONFIRMATION SYSTEM (TCS)
K113808 · LJS
C.R. Bard, Inc.
General Hospital · 87d
Cleared Mar 19, 2012
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K110536 · LYZ
Zibo Tengyue Plastic Products Co., Ltd.
General Hospital · 388d
Cleared Mar 15, 2012
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WITH ALOE VERA, GREEN COLOR
K113749 · LYZ
Full Synergy Medical Products, Inc.
General Hospital · 85d
Cleared Mar 14, 2012
VIAVALVE SAFETY IV CATHETER
K113700 · FOZ
Smiths Medical Asd, Inc.
General Hospital · 89d
Cleared Mar 14, 2012
ENFLOW IV FLUID WARMER
K112902 · LGZ
Vital Signs, Inc.
General Hospital · 162d