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"
1585–1608 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Nov 05, 2015
elance Vital Signs Monitor, Central Monitor Software
K150329 · MHX
Spacelabs Healthcare
Cardiovascular · 268d
Cleared Nov 04, 2015
Dimension Tacrolimus Flex® Reagent Cartridge (TAC), Dimension Tacrolimus...
K150168 · MLM
Siemens Healthcare Diagnostics
Toxicology · 282d
Cleared Nov 02, 2015
PROBEAT-V
K152592 · LHN
Hitachi, Ltd., Health Care Company
Radiology · 53d
Cleared Nov 02, 2015
Avance Y-Connector S
K151872 · OMP
Molnlycke Health Care Us, LLC
General & Plastic Surgery · 116d
Cleared Oct 30, 2015
Philips Lumify Diagnostic Ultrasound System
K152899 · IYN
Philips Healthcare, Inc.
Radiology · 29d
Cleared Oct 30, 2015
Cardinal Health Sterilization Wrap
K151788 · FRG
Cardinal Health200, LLC
General Hospital · 121d
Cleared Oct 30, 2015
Vera
K150462 · LXJ
Reflexion Health, Inc.
Physical Medicine · 249d
Cleared Oct 29, 2015
EXTENDED LIFE CAPD TRANSFER SET, PERITONEAL DIALYSIS TITANIUM CATHETER...
K152675 · KDJ
Baxter Healthcare
Gastroenterology & Urology · 41d
Cleared Oct 29, 2015
FlexiCap Disconnect Cap with Povidone-Iodine Solution, MiniCap with...
K152129 · KDJ
Baxter Healthcare Corporation
Gastroenterology & Urology · 90d
Cleared Oct 27, 2015
SIGNA Pioneer
K153003 · LNH
Ge Healthcare
Radiology · 14d
Cleared Oct 23, 2015
Emit II Plus Buprenorphine Assay, Emit II Plus Specialty Drug...
K150606 · DJG
Siemens Healthcare Diagnostics, Inc.
Toxicology · 227d
Cleared Oct 16, 2015
Sensus Healthcare Superficial X-ray Radiation Therapy System with Ultrasonic...
K150037 · JAD
Sensus Healthcare
Radiology · 280d
Cleared Oct 02, 2015
Extended Range Shifter for PROBEAT-V
K152207 · LHN
Hitachi, Ltd., Health Care Company
Radiology · 57d
Cleared Sep 29, 2015
LOGIQ S8
K152195 · IYN
Ge Healthcare
Radiology · 55d
Cleared Sep 24, 2015
iHealth BP3L Wireless Blood Pressure Monitor
K152003 · DXN
Andon Health Co, Ltd.
Cardiovascular · 66d
Cleared Sep 23, 2015
iHealth View BP7S Wireless Blood Pressure Wrist Monitor
K152379 · DXN
Andon Health Co, Ltd.
Cardiovascular · 33d
Cleared Sep 23, 2015
Contour Next Control Solution
K151742 · JJX
Bayer Healthcare
Chemistry · 86d
Cleared Sep 21, 2015
CARESTREAM Vue Motion
K151774 · LLZ
Carestream Health, Inc.
Radiology · 82d
Cleared Sep 18, 2015
Circumplast Circumcision Device
K151095 · HFX
Novadien Healthcare
Obstetrics & Gynecology · 148d
Cleared Sep 18, 2015
Dimension Vista MMB Assay
K143720 · JHY
Siemens Healthcare Diagnostics
Chemistry · 263d
Cleared Sep 18, 2015
DeVilbiss Intellipap2/DeVilbiss BLUE
K143677 · BZD
Devilbiss Healthcare, LLC
Anesthesiology · 268d
Cleared Sep 09, 2015
Cryocare CS-3 Surgical System version 5
K151968 · GEH
Healthtronics
General & Plastic Surgery · 55d
Cleared Sep 08, 2015
Fully Automatic Electronic Blood Pressure Monitor
K151460 · DXN
Andon Health Co, Ltd.
Cardiovascular · 99d
Cleared Sep 02, 2015
Cardinal Health NPWT PRO HC
K150124 · OMP
Cardinalhealth
General & Plastic Surgery · 225d