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

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175,820 results
134545–134568 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 14, 1988
PROLOG MP 658M PULSE GENERATOR
K883087 · DXY
Pacesetter Systems
Cardiovascular · 55d
Cleared Sep 14, 1988
AMBU SPUR (SINGLE PATIENT USE RESUSCITATOR)
K883434 · BTM
Ambu, Inc.
Anesthesiology · 30d
Cleared Sep 14, 1988
INSTRUMENTARIUM ULF MR IMAGING SYSTEM
K883622 · LNH
Instrumentarium Corp.
Radiology · 20d
Cleared Sep 13, 1988
STERIS SYSTEM 1 PROCESSOR AND 20 STERILANT
K875280 · MED
Steris C/O Medical Device...
General Hospital · 264d
Cleared Sep 13, 1988
MRM GASTROSTOMY BELT
K882089 · KNT
Mrm Products, Inc.
Gastroenterology & Urology · 117d
Cleared Sep 13, 1988
COMPAT (R) ENTERAL DELIVERY SYSTEM
K882218 · KNT
Sandoz Nutrition
Gastroenterology & Urology · 110d
Cleared Sep 13, 1988
FILLING VOLUME OPTION
K882295 · LJH
Eris Medical Technology
Gastroenterology & Urology · 103d
Cleared Sep 13, 1988
PUNCH MYRINGOTOMY SYSTEM
K882689 · ETD
Xomed, Inc.
Ear, Nose, Throat · 75d
Cleared Sep 13, 1988
FRESENIUS F8 DIALYZER
K883195 · KDI
Fresenius USA, Inc.
Gastroenterology & Urology · 47d
Cleared Sep 13, 1988
TECHNICON RA-100(TM) SYSTEM
K883209 · JJE
Technicon Instruments Corp.
Chemistry · 46d
Cleared Sep 13, 1988
LIPOPHOR(TM) SYST, HUMAN SERUM LIPOPROTEIN CONTROL
K883247 · JJY
Quantimetrix Medical Industries
Chemistry · 42d
Cleared Sep 13, 1988
PRL-QUANT
K883269 · CFT
Leeco Diagnostics, Inc.
Chemistry · 41d
Cleared Sep 13, 1988
EMAX PRECISION MICROPLATE READER
K883302 · JJQ
Molecular Devices Corp.
Chemistry · 40d
Cleared Sep 13, 1988
VENTREX COATED TUBE TSH
K883342 · JLW
Ventrex Laboratories, Inc.
Chemistry · 35d
Cleared Sep 13, 1988
IQ HDL CHOLESTEROL
K883353 · LBR
Bd Becton Dickinson Vacutainer...
Chemistry · 35d
Cleared Sep 13, 1988
HANDSWITCHING MONOPOLAR PENCIL
K883396 · GEI
New England Surgical Instrument Corp.
General & Plastic Surgery · 33d
Cleared Sep 13, 1988
URIC ACID REAGENT (PRODUCT #88219)
K883404 · KNK
Hichem Diagnostics
Chemistry · 33d
Cleared Sep 13, 1988
TRIGLYCERIDES REAGENT (PRODUCT #88218)
K883405 · CDT
Hichem Diagnostics
Chemistry · 33d
Cleared Sep 13, 1988
BIOTROL URIC ACID ENZYMATIQUE TRINDER
K883428 · KNK
Biotrol, USA, Inc.
Chemistry · 29d
Cleared Sep 13, 1988
VISION(R) PROTHROMBIN TIME
K883441 · GJS
Abbott Laboratories
Hematology · 29d
Cleared Sep 13, 1988
THORACIC CATHETERS
K883474 · GBX
Westmark, Sterile Packing Systems,...
General & Plastic Surgery · 28d
Cleared Sep 13, 1988
STRYKER PRESSURE MONITOR SYSTEM
K883485 · FTY
Stryker Corp.
General & Plastic Surgery · 28d
Cleared Sep 13, 1988
DURAZYME(R) CPK
K883504 · CGS
American Monitor Corp.
Chemistry · 27d
Cleared Sep 13, 1988
S 21 INSTRUMENT STAND
K883578 · FSH
Carl Zeiss, Inc.
General & Plastic Surgery · 22d