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"
1969–1992 of 5,280
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Mar 01, 2013
DENTAVIT, MONARCH, ACROTONE, SENATOR, DENTORIUM
K122955 · ELM
Wright Health Group , Ltd.
Dental · 157d
Cleared Feb 28, 2013
LOFRIC SENSE
K123751 · EZD
Wellspect Healthcare
Gastroenterology & Urology · 84d
Cleared Feb 28, 2013
DURABLUE STERILIZATION WRAP
K123289 · FRG
Cardinal Health-Medical Products and...
General Hospital · 129d
Cleared Feb 28, 2013
CARESCAPE RESPIRATORY MODULES, E-SCO, E-SCOV, E-SCAIOV AND ACCESSORIES
K123195 · CCL
GE Healthcare Finland Oy
Anesthesiology · 140d
Cleared Feb 22, 2013
1.5T 4CH LARGE FLEX COIL, 1.5 4CH SMALL FLEX COIL
K123681 · MOS
Wipro GE Healthcare Private, Ltd.
Radiology · 84d
Cleared Feb 22, 2013
BLUE STERILE POWDER FREE NITRILE EXAMINATION GLOVE
K122727 · LZA
Northstar Healthcare Holdings
General Hospital · 170d
Cleared Feb 22, 2013
LIFESTYLES WARM LOVIN PERSONAL LUBRICANT
K122720 · NUC
Ansell Healthcare Products, LLC
Obstetrics & Gynecology · 170d
Cleared Feb 19, 2013
LIFESTYLES LUXE PREMIUM PERSONAL LUBRICANT
K122477 · NUC
Ansell Healthcare Products, LLC
Obstetrics & Gynecology · 189d
Cleared Feb 19, 2013
COMMUNIFY PACS VIEWER
K120851 · LLZ
Communify Health, LLC
Radiology · 335d
Cleared Feb 15, 2013
DIMENSION CHEMISTRY III CALIBRATORY
K123321 · JIX
Siemens Healthcare Diagnostics
Chemistry · 112d
Cleared Feb 15, 2013
DIMENSION AMMONIA FLEX REAGENT CARTRIDGE
K123320 · JIF
Siemens Healthcare Diagnostics
Chemistry · 112d
Cleared Feb 14, 2013
LIFESTYLES NATURAL PERSONAL LUBRICANT
K122054 · NUC
Ansell Healthcare Products, LLC
Obstetrics & Gynecology · 216d
Cleared Feb 11, 2013
3M VFLEX HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK
K121069 · MSH
3M Company
General Hospital · 308d
Cleared Feb 08, 2013
LINSHI NITRILE DISPOSABLE EXAM GLOVES, POWDER-FREE
K123488 · LZA
Puyang Linshi Health Co., Ltd.
General Hospital · 87d
Cleared Feb 08, 2013
PULSTAR LOGIX INTERMITTENT PNEUMATIC COMPRESSION SYSTEM
K123308 · JOW
Albahealth, LLC
Cardiovascular · 107d
Cleared Jan 31, 2013
POWDER-FREE NITRILE EXAMINATION GLOVES (COOL BLUE)
K122696 · LZA
Cardinal Health, Inc.
General Hospital · 149d
Cleared Jan 23, 2013
DURABLUE STERILIZATION WRAP
K123857 · FRG
Cardinal Health200, LLC
General Hospital · 40d
Not Cleared Jan 23, 2013
FERRISCAN R2-MRI ANALYSIS SYSTEM
DEN130012 · PCS
Resonance Health Analysis Services...
Radiology · 21d
Cleared Jan 17, 2013
TEXTURED, NATURAL TO OFF-WHITE, LATEX, STERILE, POWDER FREE EXAMINATION...
K122788 · LYY
Northstar Healthcare Holdings
General Hospital · 128d
Cleared Jan 17, 2013
AVANCE FOAM DRESSING KIT INCL. TRANSPARENT FILM, TRANSFER PAD (SMALL, MEDIUM,...
K122132 · OMP
Molnlycke Health Care
General & Plastic Surgery · 183d
Cleared Jan 11, 2013
1.5T GEM RT OPEN ARRAY
K123327 · MOS
Ge Healthcare Coils (Usa Instruments,...
Radiology · 77d
Cleared Jan 10, 2013
INTERLINK SYSTEM BURETROL SOLUTION SETS, INTERLINK SYSTEM BURETROL SOLUTION...
K123874 · FPA
Baxter Healthcare Corp
General Hospital · 24d
Cleared Jan 09, 2013
MERITS MODEL P322FWD POWERED WHEELCHAIR
K122357 · ITI
Merits Health Products Co., Ltd.
Physical Medicine · 159d
Cleared Jan 08, 2013
INTERLINK SYSTEM LEVER LOCK CANNULA WITH CHECK VALVE, SECONDARY MEDICATION...
K123868 · FPA
Baxter Healthcare Corp
General Hospital · 22d