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

5,277 results for "health"
1489–1512 of 5,277
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Dec 08, 2016
Reprocessed Response Diagnostic Electrophysiology Catheters
K161827 · NLH
Innovative Health, LLC
Cardiovascular · 156d
Cleared Dec 06, 2016
Reprocessed Supreme Diagnostic Electrophysiology Catheters
K161769 · DRF
Innovative Health, LLC
Cardiovascular · 161d
Cleared Dec 05, 2016
EZstim*III Peripheral Nerve Stimulator/Nerve Locator
K162048 · KOI
Halyard Health - Irvine
Anesthesiology · 133d
Cleared Dec 05, 2016
WELL LIFE Wireless TENS/EMS Stimulator, Models WR-2605/2605A
K161453 · NUH
Well-Life Healthcare Limited
Neurology · 193d
Cleared Dec 01, 2016
Phasor Drill
K161704 · HBE
Biotex, Inc.
Neurology · 164d
Cleared Nov 30, 2016
Clarius Ultrasound System
K163138 · IYN
Clarius Mobile Health Corp.
Radiology · 21d
Cleared Nov 30, 2016
Solution Set for Epidural Use
K161323 · FPA
Baxter Healthcare Corporation
General Hospital · 203d
Cleared Nov 23, 2016
PolyPlex Wound Dressing
K160872 · FRO
Global Health Solutions, LLC
General & Plastic Surgery · 238d
Cleared Nov 22, 2016
Evolv Model BP7000 Upper Arm Blood Pressure Monitor
K162092 · DXN
Omron Healthcare, Inc.
Cardiovascular · 117d
Cleared Nov 18, 2016
Fully Automatic Electronic Blood Pressure Monitor
K162230 · DXN
Adon Health Co., Ltd.
Cardiovascular · 102d
Cleared Nov 18, 2016
Discovery NM 750b Bopsy
K160933 · IYX
Ge Healthcare
Radiology · 228d
Cleared Nov 17, 2016
ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI)...
K162538 · JIT
Siemens Healthcare Diagnostics
Chemistry · 66d
Cleared Nov 17, 2016
Avance Abdominal Dressing Kit
K161939 · OXJ
Molnlycke Health Care Us, LLC
General & Plastic Surgery · 126d
Cleared Nov 16, 2016
Xperius Ultrasound System
K163020 · IYN
Philips Health Care
Radiology · 16d
Cleared Nov 15, 2016
Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL)
K161494 · CGX
Siemens Healthcare Diagnostics, Inc.
Chemistry · 167d
Cleared Nov 15, 2016
SynergEyes A&M (paflufocon D hem-iberfilcon A) Hybrid Daily Wear Contact...
K153714 · HQD
Synergeyes, Inc.
Ophthalmic · 327d
Cleared Nov 04, 2016
Avance Foam Dressing Kit - XL
K161935 · OMP
Molnlycke Health Care Us, LLC
General & Plastic Surgery · 113d
Cleared Nov 03, 2016
Senographe Pristina
K162268 · MUE
Ge Healthcare
Radiology · 83d
Cleared Nov 03, 2016
Avance Gauze Dressing Kits
K161948 · OMP
Molnlycke Health Care Us, LLC
General & Plastic Surgery · 111d
Cleared Nov 02, 2016
Reprocessed Inquiry Optima Plus Steerable Diagnostic EP Catheter, Reprocessed...
K160421 · NLH
Innovative Health, LLC
Cardiovascular · 260d
Cleared Oct 31, 2016
Unger Quad Injector
K161483 · LCJ
Stradis Healthcare
General & Plastic Surgery · 153d
Cleared Oct 28, 2016
Gammex Cut-Resistant Glove Liner
K160974 · KGO
Ansell Healthcare Products, LLC
General Hospital · 204d
Cleared Oct 28, 2016
ClearVision ExamVue Flat Panel Detector
K160143 · MQB
Jpi Healthcare, Inc.
Radiology · 281d
Cleared Oct 28, 2016
Xonrid Gel
K152533 · FRO
Helsinn Healthcare SA
General & Plastic Surgery · 421d