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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
137641–137664 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 11, 1988
ALBUMIN, BROMCRESOL GREEN DYE-BINDING
K875070 · CIX
Tech-Co, Inc.
Chemistry · 33d
Cleared Jan 07, 1988
DELTA SCRUB
K872823 · GEC
Pacific Biosystems, Inc.
General & Plastic Surgery · 175d
Cleared Jan 07, 1988
MODIFIED MULTICOR AND OMNI-STANICOR PACEMAKERS
K873158 · DXY
Tpl-Cordis, Inc.
Cardiovascular · 150d
Cleared Jan 07, 1988
CARDIOFAX-V ECG-8110A
K873874 · DSI
Nihon Kohden America, Inc.
Cardiovascular · 107d
Cleared Jan 07, 1988
BARD DESAI CATHETER ELECTRODE
K873995 · DRF
C.R. Bard, Inc.
Cardiovascular · 98d
Cleared Jan 07, 1988
INFECTION CONTROL GOGGLE (TSE FONG)/STER/NON-STER
K874296 · FXX
Ulti-Med Intl., Inc.
General Hospital · 79d
Cleared Jan 07, 1988
AUDIOTONE MODEL MSP, IN-THE-EAR HEARING AID
K874385 · ESD
Audiotone, Inc.
Ear, Nose, Throat · 73d
Cleared Jan 07, 1988
PLAYTEX NON & DEODORANT TAMPONS + PRIVATE LABEL
K874509 · HIL
Playtex, Inc.
Obstetrics & Gynecology · 66d
Cleared Jan 07, 1988
POLYFLEX(R) EPICARDIAL 439-04 IMPLANT PACING LEAD
K874531 · DTB
Intermedics, Inc.
Cardiovascular · 65d
Cleared Jan 07, 1988
PROXIMAL FEMORAL REPLACEMENT PROSTHESIS
K874575 · JDG
Dow Corning Wright
Orthopedic · 62d
Cleared Jan 07, 1988
HISTOBRUSH
K874604 · HHT
Spectrum Co.
Obstetrics & Gynecology · 59d
Cleared Jan 07, 1988
REFERENCE HIGH LEVEL ASSAYED CHEM. CONTROL SERUM
K874809 · JJY
Biotrol, USA, Inc.
Chemistry · 48d
Cleared Jan 07, 1988
MULTICHEM HDL PRECIPITATING REAGENT #S0914
K874820 · LBR
Simmler, Inc.
Chemistry · 44d
Cleared Jan 07, 1988
FLEXIE THE COPPER SHANK NEEDLE
K874891 · KCW
Skin Deep, Inc.
General & Plastic Surgery · 37d
Cleared Jan 07, 1988
ORTHOMET PIN SYSTEM
K874913 · HTY
Orthomet, Inc.
Orthopedic · 35d
Cleared Jan 07, 1988
ORTHOMET WIRE FOR SUTURE, CERCLAGE
K874919 · JDQ
Orthomet, Inc.
Orthopedic · 35d
Cleared Jan 07, 1988
IN-THE-EAR HEARING AID
K875009 · ESD
House of Hearing Aids, Ltd.
Ear, Nose, Throat · 34d
Cleared Jan 07, 1988
ORTHOMET BONE SCREWS
K875050 · HWC
Orthomet, Inc.
Orthopedic · 30d
Cleared Jan 07, 1988
DEGANIA SILICONE TOURNIQUET
K875092 · GAX
Degania Silicone , Ltd.
General & Plastic Surgery · 28d
Cleared Jan 06, 1988
MODEL 3000 INFUSION PUMP
K871881 · FRN
Bd Becton Dickinson Vacutainer...
General Hospital · 237d
Cleared Jan 06, 1988
MODEL 980-CARDIOSCOPE AT-3 ELECTROCARDIOGRAPH
K872658 · DPS
Del Mar Avionics
Cardiovascular · 183d
Cleared Jan 06, 1988
LP-3000 HIGH RESOLUTION ELECTROCARDIOGRAPH
K872928 · DQK
Fidelity Medical, Inc.
Cardiovascular · 163d
Cleared Jan 06, 1988
DISPOSABLE I.V. ADMINISTRATION SET
K872953 · FPA
Mac Lee Medical Products
General Hospital · 161d
Cleared Jan 06, 1988
ULTRASPOT MICROMANIPULATOR
K873443 · GEX
Cooper Lasersonics, Inc.
General & Plastic Surgery · 132d