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"
1561–1584 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jan 19, 2016
Lustre PRO Light System
K143713 · GEX
Ambicare Health, Ltd.
General & Plastic Surgery · 386d
Cleared Jan 15, 2016
HEALTHMYNE
K153289 · LLZ
Healthmyne, Inc.
Radiology · 63d
Cleared Jan 11, 2016
Sysmex Automated Blood Coagulation Analyzer CS-5100
K150678 · JPA
Siemens Healthcare Diagnostic...
Hematology · 301d
Cleared Jan 08, 2016
MyGlucoHealth Wireless System
K143169 · NBW
Entra Health Systems
Chemistry · 430d
Cleared Jan 07, 2016
Full Automatic (NIBP) Blood Pressure Monitor
K153214 · DXN
Health & Life Co., Ltd.
Cardiovascular · 63d
Cleared Dec 31, 2015
Ageless Health Medical Digital Thermometer
K152508 · FLL
Dongguan Ageless Health Industrial...
General Hospital · 120d
Cleared Dec 28, 2015
Solution Administration Sets with 0.2 Micron Filter
K153158 · FPA
Baxter Healthcare Corporation
General Hospital · 56d
Cleared Dec 22, 2015
ALEVE Direct Therapy (ALEVE Direct Therapy TENS device)
K152852 · NUH
Bayer Healthcare, LLC
Neurology · 84d
Cleared Dec 22, 2015
ADVIA Centaur Toxoplasma M (Toxo M)
K142826 · LGD
Siemens Healthcare Diagnostics, Inc.
Microbiology · 448d
Cleared Dec 21, 2015
Cardinal Health Sterilization Wrap
K151445 · FRG
Cardinal Health200, LLC
General Hospital · 206d
Cleared Dec 18, 2015
ADVIA Chemistry Enzyme 1 Calibrator, ADVIA Chemistry Enzyme 2 Calibrator
K153365 · JIX
Siemens Healthcare Diagnostics, Inc.
Chemistry · 28d
Cleared Dec 16, 2015
ClearVue850 Diagnostic Ultrasound System
K153480 · IYN
Philips Health Care
Radiology · 14d
Cleared Dec 14, 2015
Cardinal Health Trochanteric IM Nail System
K150769 · HSB
Cardinalhealth
Orthopedic · 265d
Cleared Dec 11, 2015
DR 600
K152639 · MQB
Agfa Healthcare N.V.
Radiology · 87d
Cleared Dec 11, 2015
Trinidad CH system, TD-LYTE Integrated Multisensor (Na, K, CI), TD-LYTE IMT...
K151767 · JGS
Siemens Healthcare Diagnostics, Inc.
Chemistry · 164d
Cleared Dec 10, 2015
Checkme Pro Health Monitor
K150869 · MWI
Viatom Technology Co., Ltd.
Cardiovascular · 253d
Cleared Dec 09, 2015
Touch Ultrasound
K152467 · IYN
Carestream Health, Inc.
Radiology · 100d
Cleared Dec 06, 2015
Vital Connect Platform, HealthPatch MD, VitalPatch
K152139 · DRG
Vitalconnect, Inc.
Cardiovascular · 125d
Cleared Dec 04, 2015
iHealth Align Gluco-Monitoring System, iHealth BG5 wireless Smart...
K150833 · NBW
Andon Health Co, Ltd.
Chemistry · 249d
Cleared Nov 25, 2015
Carestream DRX-1 System with DRX Plus 4343 Detectors
K153142 · MQB
Carestream Health, Inc.
Radiology · 26d
Cleared Nov 25, 2015
Contour Next USB Blood Glucose Monitoring System
K150942 · NBW
Bayer Healthcare
Chemistry · 231d
Cleared Nov 20, 2015
Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH...
K151792 · JLW
Siemens Healthcare Diagnostics, Inc.
Chemistry · 142d
Cleared Nov 12, 2015
Entropy Module, E-ENTROPY-01
K150298 · OLW
Ge Healthcare Filand OY
Neurology · 279d
Cleared Nov 06, 2015
Voluson E6, Voluson E8, Voluson E10 Diagnostic Ultrasound System
K152567 · IYN
Ge Healthcare
Radiology · 58d