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

5,280 results for "health"
2257–2280 of 5,280
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Mar 02, 2011
SPACELABS BLEASESIRIUS ANESTHESIA WORKSTATION
K101850 · CBK
Spacelabs Healthcare, Ltd.
Anesthesiology · 244d
Cleared Feb 25, 2011
NON-CONTACT INFRARED THERMOMETER
K102947 · FLL
K-Jump Health Co., Ltd.
General Hospital · 144d
Cleared Feb 23, 2011
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-931
K102939 · DXN
Andon Health Co, Ltd.
Cardiovascular · 142d
Cleared Feb 18, 2011
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
K110330 · DXN
Andon Health Co, Ltd.
Cardiovascular · 15d
Cleared Feb 18, 2011
ADVIA CHEMISTRY LIQUID SPECIFIC PROTEIN CALIBRATORS
K103701 · JIX
Siemens Healthcare Diagnostics, Inc.
Immunology · 60d
Cleared Feb 16, 2011
ENZYME II CALIBRATOR
K103836 · JIT
Siemens Healthcare Diagnostics, Inc.
Chemistry · 48d
Cleared Feb 08, 2011
INTEL HEALTH GUIDE
K103276 · DRG
Intel Corporation Digital Health Group
Cardiovascular · 95d
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