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
61681–61704 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 15, 2006
ETHMOID SINUS SPACER
K062458 · KAM
Acclarent, Inc.
General & Plastic Surgery · 23d
Cleared Sep 15, 2006
29G AND 30G K-PACK II NEEDLE
K062608 · FMI
Terumo Europe N.V.
General Hospital · 10d
Cleared Sep 14, 2006
VYGON NUTRILINE AND NUTRILINE TWINFLOW CATHETERS
K052475 · LJS
Vygon Us, LLC
General Hospital · 370d
Cleared Sep 14, 2006
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HAV TOTAL REAGENT PACK,CALIBRATOR,CONTROLS
K060678 · LOL
Ortho-Clinical Diagnostics, Inc.
Microbiology · 184d
Cleared Sep 14, 2006
AESCULAP PEEK VERTEBRAL BODY REPLACEMENT SYSTEM
K060762 · MQP
Aesculap, Inc.
Orthopedic · 177d
Cleared Sep 14, 2006
STRYKER DISPOSABLE LAPAROSCOPIC SCISSORS
K061225 · GEI
Stryker Corp.
General & Plastic Surgery · 135d
Cleared Sep 14, 2006
OVALTWIST PEDICLE SCREW SYSTEM
K061577 · MNH
Signus Medizintechnik GmbH
Orthopedic · 99d
Cleared Sep 14, 2006
LED PROLUX 770
K061695 · EBZ
Peng Lim Enterprise Co., Ltd.
Dental · 91d
Cleared Sep 14, 2006
TORNIER CEMENT RESTRICTOR
K061824 · LZN
Tornier
Orthopedic · 78d
Cleared Sep 14, 2006
BERNOULLI MANAGEMENT SYSTEM (MS) SOFTWARE
K061932 · MSX
Cardiopulmonary Corp.
Cardiovascular · 69d
Cleared Sep 14, 2006
BD FACSCANTO II FLOW CYTOMETER, MODEL 338960
K062087 · GKZ
Bd Biosciences
Hematology · 52d
Cleared Sep 14, 2006
DIMENSION VISTA SYSTEM DRUGS OF ABUSE CALIBRATOR (UDAT CAL - KC510)
K062162 · DKB
Dade Behring, Inc.
Toxicology · 48d
Cleared Sep 14, 2006
DIMENSION VISTA SYSTEM ECSTASY CALIBRATOR, MODEL KC520
K062182 · DLJ
Dade Behring, Inc.
Toxicology · 45d
Cleared Sep 14, 2006
SEDECAL X PLUS LP PLUS
K062335 · KPR
Sedecal., Sa.
Radiology · 35d
Cleared Sep 14, 2006
DISPOSABLE POSTERIOR LUMBAR STABILIZATION PROCEDURE KIT, MODELS 9045-01 AND...
K062391 · MRW
Triage Medical, Inc.
Orthopedic · 29d
Cleared Sep 14, 2006
CONFIDENCE EX HIGH VISCOSITY BONE CEMENT
K062424 · NDN
Disc-O-Tech Medical Technologies, Ltd.
Orthopedic · 27d
Cleared Sep 13, 2006
ALGICELL AG
K052536 · FRO
Derma Sciences Canada, Inc.
General & Plastic Surgery · 363d
Cleared Sep 13, 2006
PROXIS SYSTEM, MODEL EPS101
K060651 · NFA
St Jude Medical
Cardiovascular · 184d
Cleared Sep 13, 2006
BAXTER DUPLOSPRAY MIS APPLICATOR
K061092 · FMF
Micromedics, Inc.
General Hospital · 147d
Cleared Sep 13, 2006
ARTEGRAL IMCROWN
K061809 · EBG
Merz Dental GmbH
Dental · 78d
Cleared Sep 13, 2006
MAMMOPAD RADIOLUCENT CUSHION
K062141 · IYX
Biolucent, Inc.
Radiology · 48d
Cleared Sep 13, 2006
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFUROXIME (GN) 1-64 UG/ML
K062207 · LON
Becton, Dickinson & CO
Microbiology · 43d
Cleared Sep 13, 2006
CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.), MODEL 10759350 360
K062319 · JIX
Roche Diagnostics Corp.
Chemistry · 35d
Cleared Sep 13, 2006
XPLORER 1590
K062405 · KPR
Imaging Dynamics Company , Ltd.
Radiology · 29d