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"
2209–2232 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Feb 08, 2011
VOLUSON E6/E8/E8 EXPERT DIAGNOSTIC ULTRASOUND SYSTEM MODEL: H48681BD/...
K101236 · IYN
Ge Healthcare
Radiology · 281d
Cleared Feb 04, 2011
SPACELABS MODEL 90217A AMBULATORY BLOOD PRESSURE (ABP) MONITOR
K103732 · DXN
Spacelabs Healthcare, Ltd.
Cardiovascular · 44d
Cleared Feb 03, 2011
MONICA AN24
K101801 · OSP
Monica Healthcare
Obstetrics & Gynecology · 220d
Cleared Feb 02, 2011
VASCULAIRE COMPRESSION SYSTEM
K103113 · JOW
Venous Health Systems, Inc.
Cardiovascular · 104d
Cleared Jan 26, 2011
STAYHEALTHY BODY COMPOSITION MONITOR-BCM
K101807 · MNW
Stayhealthy, Inc.
Gastroenterology & Urology · 212d
Cleared Jan 25, 2011
DIMENSION VISA ENZ 2 CAL
K103612 · JIX
Siemens Healthcare Diagnostics, Inc.
Chemistry · 47d
Cleared Jan 21, 2011
LOW ADHERENT AFM AG DRESSINGS
K103141 · FRO
Milliken Healthcare Products, LLC
General & Plastic Surgery · 88d
Cleared Jan 21, 2011
HEALTHLIGHT MICROCONTROLLER, MINIPRO, PRONEUROLIGHT, AND PRO UNIT
K101894 · ILY
Bioremedi Therapeutic Systems, Inc.
Physical Medicine · 198d
Cleared Jan 12, 2011
DISCOVERY 3T 16 CH BODY ARRAY COIL (ANTERIOR)
K103365 · MOS
Ge Healthcare Coils (Usa Instruments,...
Radiology · 56d
Cleared Jan 03, 2011
DX-D 100
K103597 · IZL
Agfa Healthcare N.V.
Radiology · 26d
Cleared Jan 03, 2011
SUPER CHAIR FOR KIDS BY ORION
K103073 · IOR
Future Mobility Healthcare, Inc.
Physical Medicine · 77d
Cleared Dec 22, 2010
MAHURKAR TRIPLE LUMEN DIALYSIS CATHETER
K102605 · NIE
Covidien, LLC, Formerly Registered AS...
Gastroenterology & Urology · 103d
Cleared Dec 16, 2010
NITRILE CORNFLOWER BLUE POWDER-FREE EXAMINATION GLOVES WITH TESTED FOR USE...
K103249 · LZA
Cardinal Health, Inc.
General Hospital · 43d
Cleared Nov 29, 2010
INNOVANCE D-DIMER, MODEL OPBP09
K093626 · DAP
Siemens Healthcare Diagnostics
Hematology · 370d
Cleared Nov 24, 2010
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
K102690 · DXN
Andon Health Co, Ltd.
Cardiovascular · 68d
Cleared Nov 23, 2010
ENHANCED ESTRADIOL (EE2) MASTER CURVE MATERIAL
K102904 · JJX
Siemens Healthcare Diagnostics
Chemistry · 53d
Cleared Nov 23, 2010
BIOGEL ORTHOPRO INDICATOR UNDERGLOVE
K101163 · KGO
Molnlycke Health Care USA
General Hospital · 211d
Cleared Nov 19, 2010
BARRIER N95 PARTICULATE RESPIRATOR
K102923 · MSH
Molnlycke Health Care
General Hospital · 49d
Cleared Nov 04, 2010
KD-931D FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
K102631 · DXN
Andon Health Co, Ltd.
Cardiovascular · 52d
Cleared Nov 04, 2010
STERILE NEOPRENE POWDER-FREE SURGICAL GLOVES WITH NITRILE COATING
K102500 · KGO
Cardinal Health, Inc.
General Hospital · 64d
Cleared Nov 03, 2010
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
K102930 · DXN
Andon Health Co, Ltd.
Cardiovascular · 30d
Cleared Oct 29, 2010
DX-D 300
K103050 · KPR
Agfa Healthcare N.V.
Radiology · 14d
Cleared Oct 29, 2010
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
K102906 · DXN
Andon Health Co, Ltd.
Cardiovascular · 28d
Cleared Oct 26, 2010
OSSEOCONDUCT
K101718 · LYC
Steiner Laboratories Div of Steiner...
Dental · 130d