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"
1561–1584 of 5,278
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared May 12, 2016
Cardinal Health Sterile Neoprene Powder-Free Surgical Gloves with Nitrile...
K153316 · KGO
Cardinal Health, Inc.
General Hospital · 177d
Cleared May 10, 2016
Reprocessed Polaris X Steerable Diagnostic EP Catheter
K160303 · NLH
Innovative Health, LLC
Cardiovascular · 96d
Cleared May 10, 2016
Reprocessed Livewire Steerable Diagnostic EP Catheter
K160242 · NLH
Innovative Health, LLC
Cardiovascular · 99d
Cleared May 05, 2016
LOGIQ P9 and LOGIQ P7
K161047 · IYN
Ge Healthcare
Radiology · 22d
Cleared May 05, 2016
Electronic Pulse Stimulator
K153520 · NUH
Jkh Health Co., Ltd.
Neurology · 149d
Cleared Apr 29, 2016
Besmed PEEP Valve
K160112 · BYE
Besmed Health Business Corp
Anesthesiology · 101d
Cleared Apr 27, 2016
Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL)
K160202 · LEH
Siemens Healthcare Diagnostics, Inc.
Toxicology · 90d
Cleared Apr 26, 2016
Voluson P6, Voluson P8
K160162 · IYN
Ge Healthcare
Radiology · 90d
Cleared Apr 21, 2016
PROBEAT-V and accessories
K153614 · LHN
Hitachi, Ltd., Health Care Company
Radiology · 126d
Cleared Apr 15, 2016
Bullfrog Micro-Infusion Device
K153501 · KRA
Mercator Medsystems, Inc.
Cardiovascular · 130d
Cleared Apr 13, 2016
Aero Chrome* Breathable Performance Surgical Gown
K153255 · FYA
Halyard Health, Inc.
General Hospital · 155d
Cleared Apr 12, 2016
HealthChek Network Health Station
K152107 · DXN
Healthchek Network, LLC
Cardiovascular · 258d
Cleared Apr 07, 2016
Merge Hemo
K152864 · DQK
Merge Healthcare Incorporated
Cardiovascular · 190d
Cleared Apr 04, 2016
HG Pro Nitrile Powder Free Examination Gloves
K152479 · LZA
Healthy Glove Co., Ltd.
General Hospital · 217d
Cleared Apr 04, 2016
Hydroven 12, Hydroven 12 Garments
K152228 · JOW
Huntleigh Healthcare , Ltd.
Cardiovascular · 241d
Cleared Apr 01, 2016
SENTINEL CARDIOLOGY INFORMATION MANAGEMENT SYSTEM
K152881 · DQK
Spacelabs Healthcare, Ltd.
Cardiovascular · 184d
Cleared Apr 01, 2016
TRUE METRIX GO Self Monitoring Blood Glucose System
K143548 · NBW
Trividia Health, Inc.
Chemistry · 473d
Cleared Mar 31, 2016
Halyard Black-Orange Powder-Free Nitrile Exam Glove
K153708 · LZA
Halyard Health
General Hospital · 99d
Cleared Mar 29, 2016
SIGNAPioneer
K160621 · LNH
Ge Healthcare
Radiology · 25d
Cleared Mar 29, 2016
Full Automatic (NIBP) Blood Pressure Monitor
K160336 · DXN
Health & Life Co., Ltd.
Cardiovascular · 50d
Cleared Mar 29, 2016
PURE CRYOGEN
K153564 · GEX
Air Liquide Healthcare America...
General & Plastic Surgery · 106d
Cleared Mar 24, 2016
Cardinal HealthTM Sterile Latex Powder-Free Orthopedic Surgical Gloves with...
K151778 · KGO
Cardinal Health 200, Inc.
General Hospital · 267d
Cleared Mar 16, 2016
Xeleris 4.0 Processing and Review Workstation
K153355 · LLZ
Ge Healthcare
Radiology · 117d
Cleared Mar 14, 2016
Reprocessed Electrophysiology Catheter
K153153 · NLH
Innovative Health, LLC
Cardiovascular · 133d