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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

5,198 results for "health"
2737–2760 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Apr 12, 2006
ASCENSIA CONTOUR BLOOD GLUCOSE METER, MODEL 7151
K060470 · NBW
Bayer Healthcare
Chemistry · 48d
Cleared Apr 10, 2006
EZ-OX PLUS
K053117 · ECX
Air Liquide Healthcare America
Anesthesiology · 154d
Cleared Apr 07, 2006
HEALTHSTATS BPRO AMBULATORY BLOOD PRESSURE MONITORING SYSTEM
K060315 · DXN
Healthstats International Pte. , Ltd.
Cardiovascular · 58d
Cleared Apr 06, 2006
ACUTE CARE FACE MASK, MODEL RT040
K060044 · MNT
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 90d
Cleared Apr 05, 2006
ADVANCE VESSEL ANALYSIS II
K060779 · JAK
Ge Healthcare
Radiology · 14d
Cleared Apr 05, 2006
TRAM MODULE
K053121 · MHX
Ge Healthcare
Cardiovascular · 149d
Cleared Mar 29, 2006
INTERLINK SYSTEM-T-CONNECTOR EXTENSION SET, MODEL 2N3326
K060074 · FPA
Baxter Healthcare Corp
General Hospital · 78d
Cleared Mar 28, 2006
ACULIFE, MODEL SMW-01
K051197 · BWK
Inno-Health Technology, Inc.
Neurology · 322d
Not Cleared Mar 27, 2006
HEALTHCHECK(TM) HOME TEST FOR LOSS OF THE SENSE OF SMELL
DEN050007 · NRK
Fmg Innovations, Inc.
Ear, Nose, Throat · 280d
Cleared Mar 23, 2006
DOPPLEX CENTRALE
K060230 · HGM
Huntleigh Healthcare , Ltd.
Obstetrics & Gynecology · 52d
Cleared Mar 23, 2006
KHAN KINETIC TREATMENT DEVICE (KKT-M1)
K060043 · LXM
Optima Health Solutions...
Physical Medicine · 76d
Cleared Mar 23, 2006
MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS
K053229 · CAW
Merits Health Products Co., Ltd.
Anesthesiology · 125d
Cleared Mar 17, 2006
OTC TENS FOR LOW BACK PAIN RELIEF, MODEL WL-2405 AND WL-2406
K052785 · NUH
Well-Life Healthcare Limited
Neurology · 165d
Cleared Mar 10, 2006
DIGITAL RADIOGRAPHY CXDI-50C
K060433 · MQB
Canon, Inc.
Radiology · 17d
Cleared Mar 10, 2006
CT PERFUSION 4
K052839 · JAK
Ge Healthcare
Radiology · 154d
Cleared Mar 09, 2006
LIBERTY GLUCOSE CONTROL SOLUTION
K060481 · JJX
Liberty Healthcare Group, Inc.
Chemistry · 14d
Cleared Mar 09, 2006
LIBERTY GLUCOSE NORMAL CONTROL SOLUTIONS, MODEL 2120041
K060426 · JJX
Liberty Healthcare Group, Inc.
Chemistry · 16d
Cleared Mar 09, 2006
MODIFICATION TO:BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEMS
K053645 · DWJ
Arizant Healthcare, Inc.
Cardiovascular · 69d
Cleared Mar 08, 2006
WH CONVERTIBLE LIGHTWEGHT WHEELCHAIR, MODEL WHL100
K060251 · IOR
Well Home Health Products Co.
Physical Medicine · 36d
Cleared Mar 07, 2006
MERITS MODEL E SERIES LIFT CHAIRS
K060212 · INO
Merits Health Products Co., Ltd.
Physical Medicine · 39d
Cleared Feb 16, 2006
HOMECHOICE/HOMECHOICE PRO PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS...
K053512 · FKX
Baxter Healthcare Corp
Gastroenterology & Urology · 62d
Cleared Feb 16, 2006
CHUNG CHENG FAR INFRARED RAY HEALTHFUL LAMP (OR MEDICAL FIR RADIATOR), MODEL...
K053376 · ILY
Chung Cheng Electric Heating Co., Ltd.
Physical Medicine · 73d
Cleared Feb 15, 2006
HYGIA HEALTH SERVICES REPROCESSED KENDALL SCD EXPRESS SLEEVES/FOOT CUFFS
K053575 · JOW
Hygia Health Services, Inc.
Cardiovascular · 55d
Cleared Feb 13, 2006
MARCH HEALTHCARE HEALTH MONITORING KIT
K060194 · DXN
March Healthcare Corporation
Cardiovascular · 19d