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
54673–54696 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 05, 2009
VOCALIS GEL
K081815 · MIX
Cytophil, Inc.
Ear, Nose, Throat · 193d
Cleared Jan 05, 2009
VOCALIS AND VOCALIS SM
K081816 · MIX
Cytophil, Inc.
Ear, Nose, Throat · 193d
Cleared Jan 05, 2009
ASSOCIATE 2500 DUAL AND COMPACT SYSTEMS
K081877 · HQC
Dutch Ophthalmic Research Center...
Ophthalmic · 187d
Cleared Jan 05, 2009
BAUSCH & LOMB STELLARIS MICROSURGICAL SYSTEM
K082473 · HQC
Bausch & Lomb, Inc.
Ophthalmic · 131d
Cleared Jan 05, 2009
CARDIO VUE QUANTITATIVE ANALYSIS (CVQ)
K082526 · LLZ
Mri Cardiac Services, Incorporated
Radiology · 125d
Cleared Jan 02, 2009
A-LAP SET (A-LAP, EZAXESS, TROCAR)
K082291 · GCJ
Ezsurgical
General & Plastic Surgery · 144d
Cleared Jan 02, 2009
NEPTUNE HYPERBARIC VENTILATOR
K082351 · CBK
Level-5, Inc.
Anesthesiology · 140d
Cleared Jan 02, 2009
DAVOL ABSORBABLE FASTENER SYSTEM, MODEL (S) 0113080,0113081, 0113082,...
K082396 · GDW
C.R. Bard, Inc.
General & Plastic Surgery · 136d
Cleared Jan 02, 2009
THEKEN SPINE VU EPOD AND VU LPOD SYSTEM
K082712 · MAX
Theken Spine, LLC
Orthopedic · 108d
Cleared Jan 02, 2009
APNEICARE CONNECTION CENTER/INTERNET ANALYSIS
K082968 · MNR
Apneicare, LLC
Anesthesiology · 88d
Cleared Jan 02, 2009
S8 ADVANCE
K082979 · BZD
Resmed, Ltd.
Anesthesiology · 88d
Cleared Jan 02, 2009
RESSCAN-PRO
K082983 · BZD
Resmed, Ltd.
Anesthesiology · 88d
Cleared Jan 02, 2009
MICRUS MICROCOLI SYSTEM, DELTAPLUSH, MODELS CPL, DPL
K083646 · HCG
Micrus Endovascular Corporation
Neurology · 24d
Cleared Dec 31, 2008
RAPIDSENSE DRUGS OF ABUSE METHAMPHETAMINE (MET) 1000 DEVICE, MODEL 900-0050
K080455 · LAF
Quantrx Biomedical Corporation
Toxicology · 315d
Cleared Dec 31, 2008
CLEARVIEW ENDOSCOPE COVER
K080740 · EOB
Invotec International, Inc.
Ear, Nose, Throat · 289d
Cleared Dec 31, 2008
ERBE MODEL VIO 300 D WITH ACCESSORIES
K083452 · GEI
Erbe USA, Inc.
General & Plastic Surgery · 40d
Cleared Dec 30, 2008
NICOLET CORTICAL STIMULATOR
K072964 · GYC
Cardinal Health, Inc.
Neurology · 438d
Cleared Dec 30, 2008
NUMERIS COAGULATION SYSTEM WITH VISITRAX, MODEL(S) CSK-021
K082203 · OCL
Ncontact Surgical, Inc.
Cardiovascular · 147d
Cleared Dec 30, 2008
AMSCO EVOLUTION MEDIUM STEAM STERILIZER
K082435 · FLE
STERIS Corporation
General Hospital · 130d
Cleared Dec 30, 2008
VIROCULT, MODEL MW950
K082472 · LIO
Medical Wire & Equipment Company...
Microbiology · 124d
Cleared Dec 30, 2008
MERIT MICROCATHETER
K082613 · KRA
Merit Medical Systems, Inc.
Cardiovascular · 113d
Cleared Dec 30, 2008
BITTAR ZIRCONIA BLOCKS
K082652 · EIH
Bittar Zirconia Block, LLC
Dental · 109d
Cleared Dec 30, 2008
NEVONI CLASSIC, MODEL 6600-PO
K082878 · CAF
Nsr Comercio E Representacoes Ltda
Anesthesiology · 92d
Cleared Dec 30, 2008
ARTHREX MENISCAL DART, ARTHREX MENISCAL DARTSTICK, ARTHREX CHONDRAL DART
K082999 · MAI
Arthrex, Inc.
Orthopedic · 83d