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"
1825–1848 of 5,280
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Mar 14, 2014
HEALTHINTERLINK BEACON
K133252 · DRG
Healthinterlink, LLC
Cardiovascular · 143d
Cleared Mar 14, 2014
EZ-OX PLUS GENERATION II
K131386 · ECX
Air Liquide Healthcare America
Anesthesiology · 304d
Cleared Mar 12, 2014
BODIHEALTH SYSTEM
K131675 · GZJ
Eprt Technologies, Inc.
Neurology · 278d
Cleared Mar 11, 2014
BONE SUPPRESSION SOFTWARE
K133442 · MQB
Carestream Health, Inc.
Radiology · 119d
Cleared Mar 11, 2014
BPROSOFT CASP PC SOFTWARE
K131916 · DXN
Healthstats International Pte. , Ltd.
Cardiovascular · 258d
Cleared Mar 10, 2014
ADVIA CENTAUR TNI-ULTRA MASTER CURVE MATERIAL (MCM), ADVIA CENTAUR DIGOXIN...
K140267 · JJX
Siemens Healthcare Diagnostics, Inc.
Chemistry · 35d
Cleared Mar 07, 2014
IMPAX VOLUME VIEWING 3.0
K133135 · LLZ
Agfa Healthcare N.V.
Radiology · 154d
Cleared Mar 05, 2014
IMMULITE 2000 DHEA-SO4
K140258 · JJX
Siemens Healthcare Diagnostics, Inc.
Chemistry · 30d
Cleared Mar 04, 2014
HEM-7320
K133383 · DXN
Omron Healthcare, Inc.
Cardiovascular · 120d
Cleared Mar 04, 2014
ANDON BLOOD PRESSURE CUFF
K133117 · DXQ
Andon Health Co, Ltd.
Cardiovascular · 155d
Cleared Mar 04, 2014
HEALTHSTATS A-PULSE CASPAL + AND MC3100+ MONITORS AND MY-BP BP MANAGEMENT...
K131788 · DXN
Healthstats International Pte. , Ltd.
Cardiovascular · 259d
Cleared Mar 03, 2014
SKINTELL
K132800 · NQQ
Agfa Healthcare N.V.
General & Plastic Surgery · 178d
Cleared Feb 21, 2014
ADVIA CENTAUR TESTOSTERONE (TSTO)
K133491 · CDZ
Siemens Healthcare Diagnostics, Inc.
Chemistry · 100d
Cleared Feb 14, 2014
VERIZON WIRELESS CONVERGED HEALTH MANAGEMENT DEVICE
K134004 · DRG
Cellco Partnership D/B/A Verizon...
Cardiovascular · 49d
Cleared Feb 12, 2014
LOGIQ E
K133533 · IYN
Ge Healthcare
Radiology · 86d
Cleared Feb 12, 2014
HYPERSOUND AUDIO SYSTEM (HSS)
K133352 · EPF
Hypersound Health, Inc.
Ear, Nose, Throat · 104d
Cleared Feb 12, 2014
VENA PRO
K133274 · JOW
Innovamed Health, LLC
Cardiovascular · 111d
Cleared Feb 12, 2014
MEPITEL AG
K130040 · FRO
Molnlycke Health Care
General & Plastic Surgery · 401d
Cleared Feb 07, 2014
PROTEUS PATCH, PROTEUS INGESTIBLE SENSOR (ACCESSORY)
K133263 · OZW
Proteus Digital Health, Inc.
Gastroenterology & Urology · 107d
Cleared Feb 07, 2014
SONICAID FREEDOM WIRELESS FETAL MONITORING SYSTEM
K132650 · HGM
Huntleigh Healthcare Limited
Obstetrics & Gynecology · 165d
Cleared Feb 06, 2014
CARESTREAM VUE PACS VERSION 11.4 CARESTREAM VUE MOTION APPLICATION
K132824 · LLZ
Carestream Health, Inc.
Radiology · 150d
Cleared Feb 05, 2014
RT016 INSPIRATORY FILTER
K133666 · CAH
Fisher &Paykel Healthcare , Ltd.
General Hospital · 68d
Cleared Feb 05, 2014
ADVIA CENTAUR INTACT PARATHYROID HORMONE (IPTH) ASSAY
K133601 · CEW
Siemens Healthcare Diagnostics, Inc.
Chemistry · 72d
Cleared Feb 04, 2014
DUTECK(MICHEALTH)DIGITAL CLINICAL THERMOMETER
K132140 · FLL
Duteck Industrial Co., Ltd.
General Hospital · 208d