FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
86281–86304 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Mar 16, 1999
ZOLL SUPERPADZ ADULT MULTI-FUNCTION ELECTRODES, MODEL 8900-XXXX
K984582 · MKJ
Bio-Detek, Inc.
Cardiovascular · 83d
Cleared Mar 16, 1999
CARESIDE AST
K990009 · CIT
Careside, Inc.
Chemistry · 71d
Cleared Mar 16, 1999
ALADDIN II MONITORING OXYGEN/AIR MONITOR
K990293 · BZR
Hamilton Medical, Inc.
Anesthesiology · 46d
Cleared Mar 15, 1999
LOKKI DT
K980840 · GEX
Hillard W. Welch
General & Plastic Surgery · 376d
Cleared Mar 15, 1999
MAXIMA, TRUSTEX, RIA AND PREMIUM EL LES CONDOMS
K981955 · LTZ
Ls Rubber Sdn Bhd
Obstetrics & Gynecology · 284d
Cleared Mar 15, 1999
ENTERO-TEST HP, MODEL #102-01
K983119 · LIO
Hdc Corp.
Microbiology · 188d
Cleared Mar 15, 1999
HARWILL MEDICAL CERVITULA CERVICAL SPATULA
K983202 · HHT
Harwill Medical (Pty) , Ltd.
Obstetrics & Gynecology · 182d
Cleared Mar 15, 1999
BIONICARE STIMILATOR SYSTEM, MODEL BIO-1000
K983228 · NYN
Murray Electronics
Neurology · 181d
Cleared Mar 15, 1999
BRAUN THERMOSCAN IRT3020/3500 ONE SECONS EAR THERMOMETER, MODEL IRT3020/3520
K983295 · FLL
Braun AG
General Hospital · 175d