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

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176,076 results
55681–55704 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 08, 2008
LYPHOCHEK TUMOR MARKET PLUS CONTROL LEVEL 1, 2 AND 3 AND MINIPAK
K082036 · JJY
Bio-Rad Laboratories
Immunology · 53d
Cleared Sep 08, 2008
PANASIL IMPRESSION MATERIALS, INCLUDING PUTTY, BINETICS, TRAY, MONOPHASE AND...
K082560 · ELW
Kettenbach GmbH & Co. KG
Dental · 4d
Cleared Sep 05, 2008
ARDS DENTAL IMPLANTS
K071803 · DZE
Ards, Ltd.
Dental · 431d
Cleared Sep 05, 2008
BRAINLAB KNEE ESSENTIAL, BRAINLAB KNEE UNLIMITED CI KNEE, CI KNEE UNLIMITED
K073615 · HAW
Brainlab AG
Neurology · 254d
Cleared Sep 05, 2008
Z3D CONTRAST ACUITY
K080196 · LLZ
Clario Medical Imaging, Inc.
Radiology · 224d
Cleared Sep 05, 2008
POLYFLEX STENT SYSTEM WITH DELIVERY SYSTEM, MODEL M00514270, M00514280,...
K080332 · ESW
Boston Scientific Corporation
Gastroenterology & Urology · 211d
Cleared Sep 05, 2008
OLYMPUS DIRECT BILIRUBIN REAGENT, MODEL OSR6X181
K080435 · CIG
Olympus Life Science Research Europa...
Chemistry · 199d
Cleared Sep 05, 2008
CONMED LINVATEC MICROFRACTURE INSTRUMENT STERILIZATION TRAY
K080531 · KCT
Conmed Linvatec
General Hospital · 192d
Cleared Sep 05, 2008
PRECISION XCEED PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM WITH MODELS...
K080960 · NBW
Abbott Diabetes Care, Inc.
Chemistry · 155d
Cleared Sep 05, 2008
SMITH & NEPHEW, INC., PROMOS REVERSE SHOULDER SYSTEM
K081016 · PHX
Smith & Nephew, Inc.
Orthopedic · 149d
Cleared Sep 05, 2008
CARDICA PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM
K081225 · FZP
Cardica, Inc.
General & Plastic Surgery · 128d
Cleared Sep 05, 2008
XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONS0LE (IPC)
K081277 · ERL
Medtronic Xomed, Inc.
Ear, Nose, Throat · 123d
Cleared Sep 05, 2008
5MP GRAYSCALE FLAT PANEL DISPLAY, MODEL, 6GF6201-5C$2# (WHERE $ = A-Z AND # =...
K081357 · LLZ
Eizo GmbH
Radiology · 114d
Cleared Sep 05, 2008
RAYNER SINGLE USE SMALL INCISION DISPOSABLE INJECTOR, MODEL R-INJ-06
K081455 · MSS
Rayner Surgical, Inc.
Ophthalmic · 105d
Cleared Sep 05, 2008
ULTRASOUND VIDEO BRONCHOSCOPE, MODEL EB-1970UK
K081518 · EOQ
Pentax Medical Company
Radiology · 98d
Cleared Sep 05, 2008
ZEUS SMALL CERVICAL CAGE AND LARGE, EXTRA LARGE, CURVED AND STRAIGHT LUMBAR...
K081614 · ODP
Interbody Innovations, Llp
Orthopedic · 88d
Cleared Sep 05, 2008
CARBOXYLATE CEM, PHOSPHATE CEM
K081702 · EMA
S & C Polymer GmbH
Dental · 80d
Cleared Sep 05, 2008
MODIFICATION TO SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM
K081747 · NEI
Synthes (Usa)
Dental · 78d
Cleared Sep 05, 2008
METACEM, META P&BOND, METACEM SILANE CERAMIC PRIMER
K081913 · EMA
Meta Biomed Co., Ltd.
Dental · 64d
Cleared Sep 05, 2008
3M UNITEK LAVA CHAIRSIDE ORAL SCANNER
K081961 · NOF
Brontes Technologies
Dental · 58d
Cleared Sep 05, 2008
AMICAS PACS, VERSION 6.0
K082144 · LLZ
Amicas, Inc.
Radiology · 37d
Cleared Sep 05, 2008
TBD ETHICON MESH
K082216 · FTL
Ethicon, Inc.
General & Plastic Surgery · 30d
Cleared Sep 05, 2008
FORTOSS VITAL
K082383 · LYC
Biocomposites, Ltd.
Dental · 17d
Cleared Sep 05, 2008
RENASYS EZ
K082426 · OMP
Smith & Nephew, Inc.
General & Plastic Surgery · 14d