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
156313–156336 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 29, 1983
DOSIMETRIC RELEASE OF GAMMA RADIATION
K832211 · JDI
Kirschner Medical Corp.
Orthopedic · 85d
Cleared Sep 29, 1983
RUBASCAN LATEX CARD TEST
K832228 · GOK
Bd Becton Dickinson Vacutainer...
Microbiology · 80d
Cleared Sep 29, 1983
DISPOSABLE VITRECTOMY HANDPIECE
K832235 · HQE
Innovative Surgical Products, Inc.
Ophthalmic · 80d
Cleared Sep 29, 1983
CULTURE MEDIUM FOR ANTIMICROBIAL SUS
K832243 · JTZ
Carroll Biological Corp.
Microbiology · 83d
Cleared Sep 29, 1983
LIGHT HANDLE COVER
K832278 · KKX
Concept, Inc.
General Hospital · 79d
Cleared Sep 29, 1983
BEHIND-THE-EAR #123 AGCI
K832326 · ESD
Danavox, Inc.
Ear, Nose, Throat · 76d
Cleared Sep 29, 1983
DIACROM * FACTOR X KIT HA31
K832372 · GGP
Wellcome Diagnostics
Chemistry · 73d
Cleared Sep 29, 1983
DIACROM * HEPARIN
K832373 · KFF
Wellcome Diagnostics
Chemistry · 73d
Cleared Sep 29, 1983
WIDEX HEARING AID MODEL L1
K832376 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 73d
Cleared Sep 29, 1983
FUKUNDA SANGYO UNITS ELECTRONIC SPIRO
K832430 · BZG
Future Impex Corp.
Anesthesiology · 69d
Cleared Sep 29, 1983
FUKUNDA SANGYA UNITS PULMOTESTER PM60
K832431 · BZG
Future Impex Corp.
Anesthesiology · 69d
Cleared Sep 29, 1983
SPIRO ANALYZER ST-100 AUTOMATIC SPIRO
K832432 · BZG
Future Impex Corp.
Anesthesiology · 69d
Cleared Sep 29, 1983
AUTOMATIC SPIROMETER ST-200
K832433 · BZG
Future Impex Corp.
Anesthesiology · 69d
Cleared Sep 29, 1983
FOGARTY-CHIN PERIPHERAL DILATION CATH
K832474 · LIT
American Edwards Laboratories
Cardiovascular · 65d
Cleared Sep 29, 1983
FLYNN SERIES III BAG/MASK UNIT-
K832495 · BTM
O-Two Systems Intl., Inc.
Anesthesiology · 64d
Cleared Sep 29, 1983
DEVA 4
K832530 · EJS
Degussa Dental, Inc.
Dental · 62d
Cleared Sep 29, 1983
AGAR PLATE XLD
K832532 · JSH
Otisville Biotech, Inc.
Microbiology · 62d
Cleared Sep 29, 1983
FOGARTY 6MM SOFTJAW CLIP
K832554 · DXC
American Edwards Laboratories
Cardiovascular · 59d
Cleared Sep 29, 1983
OCUCARE FREEDOM PACK
K832559 · HQC
Ocular Innovations, Inc.
Ophthalmic · 59d
Cleared Sep 29, 1983
DIACROM * ATIII
K832592 · JBQ
Wellcome Diagnostics
Immunology · 58d
Cleared Sep 29, 1983
LEADED X-RAY APRON
K832601 · EAJ
E.M. Adams
Radiology · 58d
Cleared Sep 29, 1983
THYROID PROTECTIVE COLLAR
K832602 · EAJ
E.M. Adams
Radiology · 58d
Cleared Sep 29, 1983
CURIX CAPACITY FILM CENTER
K832603 · IXW
Agfa-Gevaert, Inc.
Radiology · 62d
Cleared Sep 29, 1983
LUCAE'S EAR & NASAL APPLICATORS
K832667 · KCJ
Kells Medical, Inc.
Ear, Nose, Throat · 51d