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"
1753–1776 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared May 30, 2014
FAMILY HEALTHWARE
K132173 · DRG
Sanitas, Inc.
Cardiovascular · 319d
Cleared May 28, 2014
IMMULITE 2000 SYSTEMS 3GALLERGY SPECIFIC IGE ASSAY
K132801 · DHB
Siemens Healthcare Diagnostics, Inc.
Immunology · 257d
Cleared May 23, 2014
VIVID T8/VIVID T8 PRO
K141067 · IYN
Ge Healthcare
Radiology · 29d
Cleared May 22, 2014
IHEALTH ALIGN MINI GLUCO-MONITORING SYSTEM
K133790 · NBW
Andon Health Co, Ltd.
Chemistry · 164d
Cleared May 21, 2014
MOTEX POWDERED NITRILE SURGICAL GLOVES
K132802 · KGO
Shanghai Motex Healthcare Co., Ltd.
General Hospital · 257d
Cleared May 19, 2014
MAXIO
K132108 · JAK
Perfint Healthcare Pvt, Ltd.
Radiology · 315d
Cleared May 07, 2014
BAXTER SIGMA SPECTRUM INFUSION PUMP WITH MASTER DRUG LIBRARY
K133801 · FRN
Baxter Healthcare Corporation
General Hospital · 145d
Cleared May 01, 2014
IMMULITE: 2000 FREE T4 CALIBRATION VERIFICATION MATERIAL, 2000 IGF-I...
K140818 · JJX
Siemens Healthcare Diagnostics, Inc.
Chemistry · 30d
Cleared Apr 24, 2014
QUICK RELAX PRO
K131956 · NUH
Healthcare Innovations, LLC
Neurology · 301d
Cleared Apr 14, 2014
MYHEALTHPOINT TELEHEALTH MANAGER
K132930 · DRG
Entra Health Systems
Cardiovascular · 208d
Cleared Apr 14, 2014
AVANCE® FOAM ABDOMINAL DRESSING KIT
K130852 · OXJ
Molnlycke Health Care
General & Plastic Surgery · 382d
Cleared Apr 09, 2014
EMERGENCY PORTABLE VENTILATOR
K131098 · BTL
Allied Healthcare Products, Inc.
Anesthesiology · 356d
Cleared Apr 08, 2014
ULTRAFUSE
K130531 · MQV
Baxter Healthcare Corp
Orthopedic · 403d
Cleared Apr 04, 2014
TRIBALL INCENTIVE SPIROMETER
K133873 · BWF
Besmed Health Business Corp
Anesthesiology · 105d
Cleared Apr 02, 2014
AHP 300, EMERGENCY PORTABLE VENTILATOR
K132021 · BTL
Allied Healthcare Products, Inc.
Anesthesiology · 274d
Cleared Apr 01, 2014
IMMULITE 2000: C-PEPTIDE CALIBRATION VERIFICATION MATERIAL, SHBG CALIBRATION...
K140541 · JJX
Siemens Healthcare Diagnostics, Inc.
Chemistry · 28d
Cleared Apr 01, 2014
TABLET VIEWER SOFTWARE FOR IMAGE SUITE
K140271 · LLZ
Carestream Health, Inc.
Radiology · 57d
Cleared Mar 31, 2014
ADVIA CENTAUR VITAMIN B12 MASTER CURVE MATERIAL, TOTAL HCG MASTER CURVE...
K140505 · JJX
Siemens Healthcare Diagnostics, Inc.
Chemistry · 32d
Cleared Mar 25, 2014
HC550 RESPIRATORY HUMIDIFIER, ADULT VENTILATOR CIRCUIT
K132017 · BTT
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 267d
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