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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
86785–86808 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 18, 1999
HSV-1 AND/OR -2 IGM ELISA TEST SYSTEM
K983656 · LGC
Zeus Scientific, Inc.
Microbiology · 150d
Cleared Mar 18, 1999
GLUCOMETER ELITE XL BLOOD GLUCOSE METER
K984006 · CGA
Bayer Corp.
Chemistry · 128d
Cleared Mar 18, 1999
ACL/APS FACS KIT
K984102 · MID
Louisville Apl Diagnostics, Inc.
Immunology · 121d
Cleared Mar 18, 1999
CARESIDE LYTES, CARESIDE ANALLYZER MODEL 1000
K990036 · JGS
Careside, Inc.
Chemistry · 71d
Cleared Mar 18, 1999
CRYOCHECK PREKALLIKREIN DEFICIENT PLALSMA, MODEL FDPK10/10 (10 X 1.0 ML),...
K990296 · GJT
Precision Biologic
Hematology · 49d
Cleared Mar 18, 1999
ABBOT LIQUID URINE CHEMISTRY CONTROL, MODEL 1E96-01/1E97-01
K990317 · JJY
Bio-Rad
Chemistry · 48d
Cleared Mar 18, 1999
ABBOTT LYOPHILIZED ASSAYED CHEMISTRY CONTROL MODELS #1E86-02/#1E87-02
K990394 · JJY
Bio-Rad
Chemistry · 37d
Cleared Mar 17, 1999
OSIRIS
K981153 · IYE
Huestis Medical
Radiology · 352d
Cleared Mar 17, 1999
HINGED KNEE
K982160 · KRO
Encore Orthopedics, Inc.
Orthopedic · 271d
Cleared Mar 17, 1999
VNUS CLOSURE SYSTEM
K982816 · GEI
Vnus Medical Technologies, Inc.
General & Plastic Surgery · 218d
Cleared Mar 17, 1999
PRO2 CHECK OXYGEN INDICATOR
K983500 · CCL
Medical Technology Specialists, Inc.
Anesthesiology · 162d
Cleared Mar 17, 1999
CORTEX DERMASCAN C ULTRASONIC SYSTEM
K983945 · IYO
Cortex Technology Aps
Radiology · 132d
Cleared Mar 17, 1999
EMOX
K984081 · CAW
Emox 911 CC
Anesthesiology · 121d
Cleared Mar 17, 1999
MEDIVISION LAPAROSCOPE
K984434 · GCJ
Medivision Scope Service Center, Inc.
General & Plastic Surgery · 93d
Cleared Mar 17, 1999
RIWO DRIVE SYSTEM 2302 WITH GENERATOR, SMALL MOTOR HANDLES, 8563.111, 8563.351
K984521 · EQL
Richard Wolf Medical Instruments Corp.
Ear, Nose, Throat · 86d
Cleared Mar 17, 1999
ALLROUND-E (CODE NAME RD 1710)
K984587 · EJS
J.F. Jelenko & Co., Inc.
Dental · 83d
Cleared Mar 17, 1999
MODIFICATION OF MOSS P.E.G. TRAY
K984628 · KNT
Moss Tubes, Inc.
Gastroenterology & Urology · 77d
Cleared Mar 17, 1999
CCD CAMERA, MODEL 9000
K990066 · LMA
Camtronics, Ltd.
Radiology · 68d
Cleared Mar 17, 1999
SURGITRON
K990146 · GEI
Ellman Intl., Inc.
General & Plastic Surgery · 57d
Cleared Mar 17, 1999
ULTIMAX DISTAL RADIAL (VOLAR) LOCKING PLATE SYSTEM
K990481 · HRS
Biodynamic Technologies, Inc.
Orthopedic · 29d
Cleared Mar 17, 1999
ULTIMAX CORTICAL BONE SCREWS
K990513 · HWC
Biodynamic Technologies, Inc.
Orthopedic · 27d
Cleared Mar 16, 1999
INTEGRITI PATIENT MONITOR
K980688 · MWI
Alliance Instruments
Cardiovascular · 386d
Cleared Mar 16, 1999
IMMUNO-TROL CONTROL CELLS
K984216 · JPK
Coulter Corp.
Hematology · 112d
Cleared Mar 16, 1999
DILON 2000, MODEL 2000-6X8 AND DILON 2000, MODEL 2000-5X5
K984466 · IYX
Dilon Technologies, Inc.
Radiology · 90d