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"
2785–2808 of 5,281
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared May 05, 2006
INFREX
K060246 · GZJ
Johari Digital Healthcare , Ltd.
Neurology · 94d
Cleared May 03, 2006
SENSOR WALK
K052771 · IQI
Otto Bock Healthcare LP
Physical Medicine · 215d
Cleared Apr 28, 2006
LIBERTY NORMAL GLUCOSE CONTROL SOLUTION
K060706 · JJX
Liberty Healthcare Group, Inc.
Chemistry · 43d
Cleared Apr 28, 2006
KENDALL MONOJECT PRE-FILL ADVANCED 0.9%SODIUM CHLORIDE FLUSH SYRINGES FOR...
K060339 · NGT
Tyco Healthcare/Kendall
General Hospital · 77d
Cleared Apr 26, 2006
ECP HEALTH SYSTEM, MODEL 2005
K052611 · DRN
Ecp Health, Inc.
Cardiovascular · 216d
Cleared Apr 24, 2006
BAIR PAWS TEMPERATURE MANAGEMENT SYSTEM MODEL 850
K060865 · DWJ
Arizant Healthcare, Inc.
Cardiovascular · 25d
Cleared Apr 21, 2006
HL888SF
K060835 · DXN
Health & Life Co., Ltd.
Cardiovascular · 25d
Cleared Apr 20, 2006
MODIFICATION TO HEALTH BUDDY APPLIANCE
K060843 · DQA
Health Hero Network, Inc.
Anesthesiology · 23d
Cleared Apr 12, 2006
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL168FV
K060729 · DXN
Health & Life Co., Ltd.
Cardiovascular · 26d
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 16, 2006
DENFIL FLOW
K060637 · EBF
Vericom Co., Ltd.
Dental · 6d
Cleared Mar 10, 2006
DIGITAL RADIOGRAPHY CXDI-50C
K060433 · MQB
Canon, Inc.
Radiology · 17d