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"
2401–2424 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared May 22, 2009
CARESTREAM DRYVIEW 5850 LASER IMAGER
K090469 · LMC
Carestream Health, Inc.
Radiology · 88d
Cleared May 22, 2009
DIMENSION VISTA ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE, AND ENZYMATIC...
K090330 · JFY
Siemens Healthcare Diagnostics, Inc.
Chemistry · 101d
Cleared May 20, 2009
EMERGENCY PORTABLE VENTILATOR, MODEL EPV200
K090356 · BTL
Allied Healthcare Products, Inc.
Anesthesiology · 97d
Cleared May 18, 2009
AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX WORKSTATIONS
K090672 · MQB
Agfa Healthcare N.V.
Radiology · 66d
Cleared May 18, 2009
BATTERY PACK FOR MCV100 AND MCV200 EMERGENCY VENTILATORS
K083507 · BTL
Allied Healthcare Products, Inc.
Anesthesiology · 173d
Cleared May 18, 2009
MASTERSCREEN PAED - BABY BODY
K081823 · CCM
Viasys Healthcare GmbH
Anesthesiology · 325d
Cleared May 14, 2009
A1CNOW+ (10 TEST KIT, PROFESSIONAL USE) MODEL 3024, A1CNOW+(20 TEST KIT,...
K090413 · LCP
Bayer Healthcare, LLC
Chemistry · 85d
Cleared May 14, 2009
MASS CASUALTY VENTILATORS, MODELS: MCV200 AND MCV200-B
K083385 · BTL
Allied Healthcare Products, Inc.
Anesthesiology · 178d
Cleared May 08, 2009
ADVIA CENTAUR TSH3-ULTRA METHOD
K083844 · JLW
Siemens Healthcare Diagnostics
Chemistry · 135d
Cleared May 06, 2009
ASTHMA MONITOR MODEL, AM1
K090486 · BZG
Cardinal Health Germany 234 GmbH
Anesthesiology · 70d
Cleared May 06, 2009
LASER TOUCHONE
K083822 · GZJ
Laser Health Technologies, LLC
Neurology · 135d
Cleared May 01, 2009
OEC 9900 ELITE
K082781 · OWB
Ge Healthcare Surgery
Radiology · 221d
Cleared May 01, 2009
ALATECH CHAMPION VYTEX LUBRICATED MALE LATEX CONDOM
K082529 · HIS
Alatech Healthcare, LLC
Obstetrics & Gynecology · 241d
Cleared Apr 30, 2009
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-556
K090963 · DXN
Andon Health Co, Ltd.
Cardiovascular · 24d
Cleared Apr 30, 2009
GE DATEX-OHMEDA S/5 ADU CARESTATION
K090892 · BSZ
GE Healthcare Finland Oy
Anesthesiology · 30d
Cleared Apr 30, 2009
SPACELABS ELANCE VITAL SIGNS MONITORING SYSTEM AND CENTRAL MONITOR SOFTWARE
K090556 · MHX
Spacelabs Healthcare Medical...
Cardiovascular · 59d
Cleared Apr 29, 2009
DIMENSION VISTA IMMUNOGLOBULIN A FLEX REAGENT CARTRIDGE (IGA), AND DIMENSION...
K090594 · CFN
Siemens Healthcare Diagnostics
Immunology · 55d
Cleared Apr 27, 2009
DIMENSION VISTA AFP FLEX REAGENT CARTRIDGE, MODEL 6454
K090236 · LOJ
Siemens Healthcare Diagnostics
Immunology · 84d
Cleared Apr 27, 2009
DS N95 SURGICAL MASKS AND FLAT SURGICAL
K090131 · MSH
Shanghai Dasheng Health Products
General Hospital · 96d
Cleared Apr 22, 2009
MODIFICATION TO V-LOC 180 ABSORBABLE WOUND CLOSURE DEVICE
K091087 · GAM
Surgical Devices, Tyco Healthcare...
General & Plastic Surgery · 7d
Cleared Apr 22, 2009
HYGIA HEALTH SERVICES REPROCESSED COMPRESSION SLEEVES / FOOT CUFFS
K090074 · JOW
Hygia Health Services, Inc.
Cardiovascular · 100d
Cleared Apr 15, 2009
RTX 3371
K090886 · DRG
Tunstall Healthcare
Cardiovascular · 15d
Cleared Apr 10, 2009
WELL LIFE SELF ADHESIVE ELECTRODE / MODELS: CM, FA, PU AND SP
K082065 · GXY
Well-Life Healthcare Limited
Neurology · 262d
Cleared Apr 06, 2009
CARESTREAM DRX-1 SYSTEM
K090318 · MQB
Carestream Health, Inc.
Radiology · 56d