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

5,280 results for "health"
2305–2328 of 5,280
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Sep 10, 2010
MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANEL, B1017 PANEL SERIES
K101425 · LRG
Siemens Healthcare Diagnostics
Microbiology · 113d
Cleared Aug 31, 2010
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-930
K101950 · DXN
Andon Health Co, Ltd.
Cardiovascular · 50d
Cleared Aug 31, 2010
GE LOGIQ P5 MODEL H44662LD
K101878 · IYN
Ge Healthcare
Radiology · 56d
Cleared Aug 27, 2010
DECOMPRESSION OF CHOICE AND NEURO DECOMPRESSION DEVICE
K101889 · ITH
Pivotal Health Solutions
Physical Medicine · 51d
Cleared Aug 19, 2010
SYNERGY CT PICC
K101329 · LJS
Health Line International Corporation
General Hospital · 99d
Cleared Aug 05, 2010
MULTI-PURPOSE HEALTH DEVICE
K093322 · BWK
Upc Medical Supplies, Inc. Dba United...
Neurology · 286d
Cleared Aug 04, 2010
CSI MANAGED HEALTH SYSTEM MODEL: CSI MODEL 9K
K101198 · DXN
Computerized Screening, Inc.
Cardiovascular · 97d
Cleared Aug 02, 2010
ADVIA CHEMISTRY ACETAMINOPHEN REAGENT, MODEL REF 07989138
K100200 · LDP
Siemens Healthcare Diagnostics
Toxicology · 189d
Cleared Jul 30, 2010
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL: KD-5963NU, KD-5008
K101010 · DXN
Andon Health Co, Ltd.
Cardiovascular · 109d
Cleared Jul 28, 2010
ADVIA 2120/2120I BODY FLUIDS
K090346 · GKZ
Siemens Healthcare Diagnostics
Hematology · 532d
Cleared Jul 23, 2010
REPROCESSED COMPRESSION SLEEVES
K100909 · JOW
Ascent Healthcare Solutions
Cardiovascular · 113d
Cleared Jul 22, 2010
CPR MASK
K083418 · CBP
Firstar Healthcare Co., Ltd.
Anesthesiology · 611d
Cleared Jul 09, 2010
LOCI 8 CALIBRATOR, MODEL KC 646
K101460 · JIX
Siemens Healthcare Diagnostics
Chemistry · 44d
Cleared Jul 02, 2010
MD VISION SYSTEM
K101474 · DXJ
Perkins Healthcare Technologies
Cardiovascular · 35d
Cleared Jul 02, 2010
ACTIPROTECT UC N95 RESPIRATOR
K093189 · ORW
Glaxosmithkline Consumer Healthcare
General Hospital · 266d
Cleared Jul 02, 2010
MERITS MODEL N SERIES NEBULIZER COMPRESSORS
K092859 · CAF
Merits Health Products Co., Ltd.
Anesthesiology · 288d
Cleared Jun 29, 2010
MODIFICATION TO INTEL HEALTH GUIDE PHS6000
K101178 · DRG
Intel Corp.
Cardiovascular · 63d
Cleared Jun 29, 2010
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5965
K100940 · DXN
Andon Health Co, Ltd.
Cardiovascular · 85d
Cleared Jun 25, 2010
4 CHANNELS MULTIPLE MODEL DIGITAL ELECTRICAL STIMULATOR, MODEL NUVOSTIM IV,...
K100399 · GZJ
Well-Life Healthcare Limited
Neurology · 129d
Cleared Jun 23, 2010
8 CHANNEL CARDIAC PHASED ARRAY COIL
K101492 · MOS
Ge Healthcare Coils (Usa Instruments,...
Radiology · 22d
Cleared Jun 22, 2010
DUAL LUER LOCK CAP, MODEL 2C6250
K101385 · FPA
Baxter Healthcare Corp
General Hospital · 35d
Cleared Jun 08, 2010
A-PULSE CASPRO MODEL T7100, A-PULSE CASPAL MODEL T7200
K101002 · DXN
Healthstats International Pte. , Ltd.
Cardiovascular · 57d
Cleared Jun 04, 2010
ORION II (HEAVY DUTY 350 LBS AND 500 LBS)
K101277 · IOR
Future Mobility Healthcare, Inc.
Physical Medicine · 29d
Cleared May 28, 2010
RESPIRATORY HUMIDIFIER , HEATED DELIVERY SYSTEM, ADAPTOR, MODELS MR880,...
K100554 · BTT
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 91d