FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

5,281 results for "health"
3385–3408 of 5,281
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Apr 21, 2000
MODIFICATION TO CONVERTORS SURGICAL GOWNS
K001189 · FYA
Allegiance Healthcare Corp.
General Hospital · 9d
Cleared Apr 10, 2000
PRO.DUCT CATHETER, MODEL CTH03
K000135 · KNW
Pro. Duct Health, Inc.
Gastroenterology & Urology · 83d
Cleared Apr 07, 2000
HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED LAXTEX EXAMINATION GLOVE
K000828 · LYY
Pamitex Industries Sdn Bhd
General Hospital · 24d
Cleared Mar 30, 2000
MODIFICATION TO AIRLIFE HEATED VENTILATOR AND ANESTHESIA BREATHING CIRCUITS
K000697 · BZE
Allegiance Healthcare Corp.
Anesthesiology · 29d
Cleared Mar 30, 2000
MONOFILAMENT BIOSYN SUTURE
K000037 · GAM
United States Surgical, A Division of...
General & Plastic Surgery · 84d
Cleared Mar 29, 2000
HEALTH-PLUS, SANITEX, RELIANCE POWEDER-FREE STERILE LATEX SURGICAL GLOVES
K993201 · KGO
Pamitex Industries Sdn Bhd
General Hospital · 187d
Cleared Mar 17, 2000
CONVERTORS EQUIPMENT DRAPES
K000417 · KKX
Allegiance Healthcare Corp.
General Hospital · 38d
Cleared Mar 10, 2000
SPIRAL RADIUS RODDING SYSTEM
K000009 · KWQ
United States Surgical, A Division of...
Orthopedic · 67d
Cleared Mar 08, 2000
LUER ACCESS UNIVERSAL VIAL ADAPTER
K000657 · FMI
Baxter Healthcare Corp
General Hospital · 9d
Cleared Feb 18, 2000
CONVERTORS SURGICAL GOWNS, STERILE
K994244 · FYA
Allegiance Healthcare Corp.
General Hospital · 64d
Cleared Feb 11, 2000
KODAK HOME HEALTH MONITORING SYSTEM
K983928 · MWI
Eastman Kodak Company
Cardiovascular · 463d
Cleared Feb 10, 2000
HEALTH-PLUS, SANITEX, RELIANCE, POWDER-FREE MULTI-PLY LATEX EXAMINATION GLOVE...
K993918 · LYY
Pamitex Industries Sdn Bhd
General Hospital · 84d
Cleared Feb 09, 2000
POWERED DENTAL POWDERED EXAMINATION GLOVES, WITH PROTEIN CONTENT LABELING...
K994162 · LYY
Allegiance Healthcare Corp.
General Hospital · 62d
Cleared Jan 27, 2000
GAMBRO DQM 200
K990039 · LFP
Gambro Healthcare
Chemistry · 386d
Cleared Jan 24, 2000
BABY DOPPLEX 4000, MODEL BD 4000
K990569 · HGM
Huntleigh Healthcare, Inc.
Obstetrics & Gynecology · 335d
Cleared Jan 14, 2000
INFRARED EAR THERMOMETER, MODEL KI-8120
K984551 · FLL
K-Jump Health Co., Ltd.
General Hospital · 388d
Cleared Jan 12, 2000
CONVERTORS SURGICAL DRAPES
K993795 · KKX
Allegiance Healthcare Corp.
General Hospital · 64d
Cleared Dec 29, 1999
HEALTH-PLUS, SANITEX, RELIANCE, BLUE PRE-POWDERED LATEX EXAMINATION GLOVES,...
K993621 · LYY
Pamitex Industries Sdn Bhd
General Hospital · 64d
Cleared Dec 20, 1999
ALATECH LATEX CONDOM
K993887 · HIS
Alatech Healthcare, LLC
Obstetrics & Gynecology · 34d
Cleared Dec 10, 1999
AIRLIFE HEATED VENTILATOR AND BREATHING CIRCUITS
K993833 · BZE
Allegiance Healthcare Corp.
Anesthesiology · 28d
Cleared Dec 07, 1999
BIONIKE AQ PHENCYCLIDINE (PCP) TEST
K993945 · LCM
Bionike Laboratories, Inc.
Toxicology · 18d
Cleared Dec 03, 1999
HL148 & HL168
K990807 · DXN
Health & Life Co., Ltd.
Cardiovascular · 267d
Cleared Nov 24, 1999
MERIDIAN HEMODIALYSIS MACHINE, MODEL 5M5576
K992894 · KDI
Baxter Healthcare Corp
Gastroenterology & Urology · 89d
Cleared Nov 23, 1999
HEALTHBUDDY WITH DEVICE CONNECT [GLUCOSE METER]
K993128 · CGA
Health Hero Network, Inc.
Chemistry · 64d