FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
155473–155496 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Sep 29, 1983
HSI ELITE #EC CUSTOM CANAL HEAR-AID
K832701 · ESD
Hearing Services, Inc.
Ear, Nose, Throat · 49d
Cleared Sep 29, 1983
SHILEY GAS FILTER
K832704 · KRI
Shiley, Inc.
Cardiovascular · 49d
Cleared Sep 29, 1983
INTRINSIC FACTOR BLOCKING ANTIBODY KIT
K832726 · CDD
Diagnostic Products Corp.
Immunology · 48d
Cleared Sep 29, 1983
RADIOTHERAPY MGMT. SYSTEM RMS-1000
K832732 · IYE
Varian Assoc., Inc.
Radiology · 55d
Cleared Sep 29, 1983
XEROX 120 SYS MAMMOGRAPHIC X-RAY
K832733 · IZH
Xerox Medical Systems
Radiology · 41d
Cleared Sep 29, 1983
KEMTEK 103 RIA GAMMA COUNTER
K832735 · JJJ
Kemble Instruments, Inc.
Chemistry · 56d