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

5,278 results for "health"
1585–1608 of 5,278
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Mar 13, 2016
Full Automatic (NIBP) Blood Pressure Monitor
K160145 · DXN
Health & Life Co., Ltd.
Cardiovascular · 52d
Cleared Mar 10, 2016
Reprocessed Diagnostic Ultrasound Catheter
K153090 · OWQ
Innovative Health, LLC
Cardiovascular · 136d
Cleared Mar 09, 2016
Gammex PI Hybrid Surgical Gloves
K151694 · KGO
Ansell Healthcare Products, LLC
General Hospital · 260d
Cleared Mar 03, 2016
Tenex Health TX System
K153299 · LFL
Tenex Health, Inc.
General & Plastic Surgery · 111d
Cleared Mar 03, 2016
IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification Material
K152061 · JZO
Siemens Healthcare Diagnostics, Inc.
Immunology · 223d
Cleared Mar 03, 2016
FULL CARE Disposable PVC Nelaton Catheter
K151745 · EZD
Shaoxing Fuqing Health Products Co.,...
Gastroenterology & Urology · 248d
Cleared Feb 26, 2016
Novilase Laser Therapy System, Model LTS-2
K160392 · GEX
Novian Health, Inc.
General & Plastic Surgery · 15d
Cleared Feb 26, 2016
LOGIQ S7 Expert
K160182 · IYN
Ge Healthcare
Radiology · 30d
Cleared Feb 25, 2016
Voluson S6, Voluson S8, Voluson S10
K160184 · IYN
Ge Healthcare
Radiology · 29d
Cleared Feb 25, 2016
McLaren Proton Therapy System
K160063 · LHN
Mclaren Health Care Corporation
Radiology · 43d
Cleared Feb 23, 2016
Navik 3D
K152160 · DQK
Apn Health, LLC
Cardiovascular · 204d
Cleared Feb 12, 2016
TraumaCad Mobile Release 2.0
K160001 · LLZ
Voyant Health, Ltd.
Radiology · 39d
Cleared Feb 12, 2016
CARESTREAM Vue PACS
K153103 · LLZ
Carestream Health, Inc.
Radiology · 109d
Cleared Feb 11, 2016
Dimension Vista LOCI Total Testosterone Flex reagent cartridge, Dimension...
K151529 · CDZ
Siemens Healthcare Diagnostics, Inc.
Chemistry · 248d
Cleared Feb 09, 2016
Dictum Health
K152645 · MWI
Dictum Health, Inc.
Cardiovascular · 146d
Cleared Feb 05, 2016
Cryocare CS Surgical System
K153489 · GEH
Healthtronics
General & Plastic Surgery · 63d
Cleared Feb 02, 2016
iHealth Track Blood Pressure Monitor
K160014 · DXN
Andon Health Co, Ltd.
Cardiovascular · 29d
Cleared Jan 26, 2016
Sysmex Automated Blood Coagulation Analyzer CS-2100i
K151259 · JPA
Siemens Healthcare Diagnostics...
Hematology · 259d
Cleared Jan 25, 2016
ImagenSPECT
K152503 · KPS
Cardiovascular Imaging Technologies
Radiology · 145d
Cleared Jan 22, 2016
Mepiseal Soft Silicone Sealant
K152741 · OMP
Molnlycke Health Care Us, LLC
General & Plastic Surgery · 121d
Cleared Jan 21, 2016
Discovery NM/CT 670 CZT
K153402 · KPS
Ge Healthcare
Radiology · 58d
Cleared Jan 21, 2016
DeVilbiss DV6WM Wireless Modem
K152810 · BZD
Devilbiss Healthcare, LLC
Anesthesiology · 115d
Cleared Jan 20, 2016
Stroke VCAR
K152584 · JAK
GE Medical Systems SCS
Radiology · 132d
Cleared Jan 19, 2016
Lustre PRO Light System
K143713 · GEX
Ambicare Health, Ltd.
General & Plastic Surgery · 386d