Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
74713–74736 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 17, 2002
GMRS PRESS FIT STEMS WITH PUREFIX HA
K022403 · LZO
Howmedica Osteonics Corp.
Orthopedic · 86d
Cleared Oct 17, 2002
WILSON-COOK CYSTOTOME
K022595 · KNS
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 73d
Cleared Oct 17, 2002
HOFFMANN 30 DEGREE PELVIC DOUBLE BALL JOINT
K022651 · LXT
Howmedica Osteonics Corp.
Orthopedic · 69d
Cleared Oct 17, 2002
CARRAKLENZ AND ULTRAKLENZ
K022670 · FRO
Carrington Laboratories, Inc.
General & Plastic Surgery · 66d
Cleared Oct 17, 2002
ECHO-VIEW 5.X, EASY-VIEW 2.X, OMNI VIEW 2.X, CARDIO-VIEW 1.X, LV ANALYSIS 1.X...
K022824 · LLZ
Tomtec Imaging Systems GmbH
Radiology · 52d
Cleared Oct 17, 2002
SHERPA MOBILITY SYSTEM (MANUAL WHEELCHAIR)
K022924 · IOR
Otto Back Healthcare, LP
Physical Medicine · 43d
Cleared Oct 17, 2002
RX 90 FEMORAL STEM AND RX 90 LATERALIZED FEMORAL STEM
K023085 · JDI
Biomet Orthopedics, Inc.
Orthopedic · 30d
Cleared Oct 17, 2002
OPTETRAK TOTAL KNEE SYSTEM OFFSET TIBIAL TRAY
K023186 · JWH
Exactech, Inc.
Orthopedic · 23d
Cleared Oct 17, 2002
OSSTAPLE
K023203 · JDR
Biomedical Ent., Inc.
Orthopedic · 22d
Cleared Oct 17, 2002
NEXGEN COMPLETE KNEE SOLUTION CRUCIATE RETAINING (CR)-FLEX FEMORAL COMPONENTS
K023211 · JWH
Zimmer, Inc.
Orthopedic · 21d
Cleared Oct 17, 2002
LINICAL PROTEIN 2 CALIBRATION VERIFIERS LEVELS A-E FOR THE BECKMAN-COULTER...
K023250 · JJY
Cliniqa Corporation
Chemistry · 17d
Cleared Oct 17, 2002
SAS STREPALERT
K023270 · GTY
Sa Scientific, Inc.
Microbiology · 16d
Cleared Oct 17, 2002
COBRA COOLED CARDIAC SURGICAL PROBE, MODEL 1596X
K023291 · GEI
Boston Scientific Corp
General & Plastic Surgery · 15d
Cleared Oct 16, 2002
SANARUS INDICA MARKER SYSTEM
K020054 · FZP
Sanarus Medical, Inc.
General & Plastic Surgery · 281d
Cleared Oct 16, 2002
SURGIFORM AUGMENTATION MATERIAL (S.F.A.M.)
K021889 · KKY
Surgical Technology Laboratories, Inc.
General & Plastic Surgery · 131d
Cleared Oct 16, 2002
MOIST PUNCTAL PLUG SYSTEM
K021936 · LZU
Moist Medical, Inc.
Ophthalmic · 126d
Cleared Oct 16, 2002
NOVUS SPECTRA
K022327 · GEX
Lumenis, Inc.
General & Plastic Surgery · 90d
Cleared Oct 16, 2002
OPTICAL INTEGRITY GENERAL SHAPED FIBER
K022338 · GEX
Optical Integrity, Inc.
General & Plastic Surgery · 90d
Cleared Oct 16, 2002
DIODENT DENTAL LASER SYSTEM
K022351 · GEX
Continuum Electro-Optics, Inc.
General & Plastic Surgery · 89d
Cleared Oct 16, 2002
TRANSEND 300 ES GUIDEWIRE, MODEL 46-814 & TRANSEND 300 FLOPPY GUIDEWIRE,...
K022357 · DQX
Boston Scientific, Target
Cardiovascular · 89d
Cleared Oct 16, 2002
BD-3000 MICROKERATOME SYSTEM, MODEL K-3000 MICROKERATOME
K022637 · HMY
Becton, Dickinson & CO
Ophthalmic · 69d
Cleared Oct 16, 2002
S&T SINGLE USE MICRO ANASTOMOSIS CLAMP
K022754 · DXC
S & T AG
Cardiovascular · 58d
Cleared Oct 16, 2002
CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE
K023065 · MKW
Dade Behring, Inc.
Chemistry · 30d
Cleared Oct 16, 2002
OLEEVA FABRIC
K023136 · MDA
Bio Med Sciences, Inc.
General & Plastic Surgery · 26d