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"
1345–1368 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Oct 19, 2017
Avail
K172079 · NUH
Omron Healthcare, Inc.
Neurology · 101d
Cleared Oct 18, 2017
Emit II Plus Oxycodone Assay
K172910 · DJG
Siemens Healthcare Diagnostics, Inc.
Toxicology · 23d
Cleared Oct 18, 2017
OTC Combo TENS/EMS System
K172809 · NUH
Well-Life Healthcare Limited
Neurology · 30d
Cleared Oct 13, 2017
DX-D Imaging Package
K172784 · MQB
Agfa Healthcare N.V.
Radiology · 28d
Cleared Oct 13, 2017
Freemie Independence, Freemie Liberty
K172772 · HGX
Dao Health
Obstetrics & Gynecology · 29d
Cleared Oct 05, 2017
Reprocessed CristaCath Diagnostic Electrophysiology Catheter
K171503 · NLH
Innovative Health, LLC
Cardiovascular · 135d
Cleared Oct 04, 2017
Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound...
K172607 · IYN
Philips Health Care
Radiology · 35d
Cleared Sep 29, 2017
Voluson E6, Voluson E8, Voluson E10
K172342 · IYN
Ge Healthcare
Radiology · 58d
Cleared Sep 28, 2017
Digital Thermometer
K170262 · FLL
K-Jump Health Co., Ltd.
General Hospital · 244d
Cleared Sep 27, 2017
Peerbridge Cor(TM) System
K171936 · DSH
Peerbridge Health, Inc.
Cardiovascular · 91d
Cleared Sep 22, 2017
IV Fat Emulsion Administration Sets
K172544 · FPA
Baxter Healthcare Corporation
General Hospital · 30d
Cleared Sep 22, 2017
Occlusion Detection Dressing Kit
K171499 · OMP
Cardinalhealth
General & Plastic Surgery · 122d
Cleared Sep 19, 2017
Digital Thermometer
K163518 · FLL
Joytech Healthcare Co. , Ltd.
General Hospital · 278d
Cleared Sep 18, 2017
Health-e-Connect System with IDA
K163664 · NDC
Alr Technologies
General Hospital · 265d
Cleared Sep 15, 2017
WowGoHealth Blood Glucose Monitoring System
K171785 · NBW
Biotest Medical Corporation
Chemistry · 92d
Cleared Sep 15, 2017
iHealth Align Gluco-Monitoring System (BG1)
K170231 · NBW
Andon Health Co, Ltd.
Chemistry · 233d
Cleared Sep 14, 2017
Clarius Ultrasound System
K172385 · IYN
Clarius Mobile Health Corp.
Radiology · 37d
Cleared Sep 09, 2017
All-in-One Health Monitor, PC-303
K170047 · MWI
Shenzhen Creative Industry Co., Ltd.
Cardiovascular · 247d
Cleared Sep 01, 2017
Senographe Pristina
K163302 · MUE
Ge Healthcare
Radiology · 283d
Cleared Aug 31, 2017
Atellica IM Ferritin Assay
K171642 · DBF
Siemens Healthcare Diagnostics, Inc.
Immunology · 90d
Cleared Aug 25, 2017
Hexagen Derm
K171191 · FRO
Global Health Solutions, LLC
General & Plastic Surgery · 123d
Cleared Aug 24, 2017
Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve -...
K170367 · MNT
Fisher and Paykel Healthcare Limited
Anesthesiology · 199d
Cleared Aug 22, 2017
INNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r)...
K162540 · KFF
Siemens Healthcare Diagnostics...
Hematology · 344d
Cleared Aug 18, 2017
Supria True64
K171738 · JAK
Hitachi Healthcare Americas Corporation
Radiology · 67d