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"
2521–2544 of 5,280
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jan 08, 2009
MYGLUCOHEALTH GLUCOSE MONITORING SYSTEMS
K081703 · NBW
Entra Health Systems, Ltd.
Chemistry · 205d
Cleared Jan 07, 2009
CALHEALTH, INC., FINGER BLOOD PRESSURE MONITOR, MDMOUSE
K081924 · DXN
Calhealth, Inc.
Cardiovascular · 184d
Cleared Dec 30, 2008
CARESTREAM PACS, MODEL CARESTREAM PACS VII
K083673 · LLZ
Carestream Health, Inc.
Radiology · 19d
Cleared Dec 30, 2008
NICOLET CORTICAL STIMULATOR
K072964 · GYC
Cardinal Health, Inc.
Neurology · 438d
Cleared Dec 19, 2008
DIMENSION VISTA LG LIGHT CHAINS, TYPE KAPPA, DIMENSION VISTA LG LIGHT CHAINS,...
K082503 · DFH
Siemens Healthcare Diagnostics
Immunology · 112d
Cleared Dec 10, 2008
DIMENSION CLINICAL CHEMISTRY SYSTEM MPO FLEX REAGENT CARTRIDGE,...
K071474 · NTV
Siemens Healthcare Diagnostics
Chemistry · 561d
Cleared Dec 02, 2008
MASTERSCOPE, MASTERSCOPE ECG, MASTERSCOPE CT
K082539 · BTY
Cardinal Health Germany 234 GmbH
Anesthesiology · 91d
Cleared Nov 28, 2008
GE ENTROPY SENSOR
K082540 · GXY
Ge Healthcare
Neurology · 87d
Cleared Nov 26, 2008
MODIFICATION TO INTEL HEALTH GUIDE, MODEL PHS6000
K083115 · DRG
Intel Corp.
Cardiovascular · 36d
Cleared Nov 26, 2008
HEALTHLINE MEDICATOR / REDINEB AEROSOL DRUG DELIVERY SYSTEM
K082541 · CAF
Medi Nuclear Corp., Inc.
Anesthesiology · 85d
Cleared Nov 19, 2008
THERAGEM PROFESSIONAL T1002
K081505 · ILY
Medica Health, Ltd.
Physical Medicine · 174d
Cleared Nov 14, 2008
CENTRICITY PACS WEB DIAGNOSTIC
K083018 · LLZ
Ge Healthcare Dynamic Imaging Solutions
Radiology · 36d
Cleared Nov 14, 2008
SPECTRAL OCT/SLO
K080460 · OBO
Opko Health, Inc.
Ophthalmic · 268d
Cleared Nov 10, 2008
MICRO-TOUCH NITRATEX STERILE NITRILE POWDER-FREE BLUE EXAMINATION GLOVES...
K082457 · LZA
Ansell Healthcare Products, Inc.
General Hospital · 76d
Cleared Oct 30, 2008
DIMENSION SIRO FLEX REAGENT CARTRIDGE AND DIMENSION SIROLIMUS CALBIRATOR,...
K081857 · NRP
Siemens Healthcare Diagnostics, Inc.
Toxicology · 121d
Cleared Oct 28, 2008
BRAVORACER PEDIATRIC MANUAL WHEELCHAIR
K082314 · IOR
Otto Bock Healthcare LP
Physical Medicine · 76d
Cleared Oct 27, 2008
MPOWRX SNORING SOLUTION
K081965 · LRK
Mpowrx Health and Wellness Products,...
Dental · 109d
Cleared Oct 24, 2008
INNOVANCE D-DIMER AND INNOVANCE D-DIMER CONTROLS
K081732 · DAP
Siemens Healthcare Diagnostics
Hematology · 127d
Cleared Oct 22, 2008
OMRON MODEL HBP-2070 VITAL SIGNS MONITOR
K082812 · MWI
Omron Healthcare, Inc.
Cardiovascular · 28d
Cleared Oct 17, 2008
MATRACELL DECELLULARIZED PULMONARY ARTERY PATCH ALLOGRAFT
K081438 · DXZ
Lifenet Health
Cardiovascular · 148d
Cleared Oct 10, 2008
LOCI N-TERMINAL PRO-BRAIN NATRIURETIC PEPTIDE CALIBRATOR, MODEL RC623
K082680 · JIT
Siemens Healthcare Diagnostics
Chemistry · 25d
Cleared Oct 10, 2008
TRICOS A RESORBABLE BONE SUBSTITUTE
K081717 · MQV
Baxter Healthcare Corp
Orthopedic · 114d
Cleared Oct 10, 2008
HEM-9000AI
K081654 · DXN
Omron Healthcare, Inc.
Cardiovascular · 120d
Cleared Oct 09, 2008
THE ADVANTAGE SERIES NON-VENTED (NV) FULL FACE MASK
K081670 · CBK
Cardinal Health 207, Inc.
Anesthesiology · 118d