FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
123409–123432 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 28, 1991
FUNKY SUNGLASS
K904981 · HQY
Monogram International,Inc.
Ophthalmic · 87d
Cleared Jan 28, 1991
SLIDEX STREPTO-KIT
K905020 · GTY
Vitek Systems, Inc.
Microbiology · 82d
Cleared Jan 28, 1991
PATIENT EXAMINATION GLOVES
K905172 · LYY
Tessile, Inc.
General Hospital · 76d
Cleared Jan 28, 1991
OSTEONICS(R) MPSS HIP STEM SERIES
K905275 · JDI
Osteonics Corp.
Orthopedic · 66d
Cleared Jan 28, 1991
TRU-TOUCH POWDER FREE
K905503 · LYZ
Bd Becton Dickinson Vacutainer...
General Hospital · 52d
Cleared Jan 28, 1991
133 SERIES BTE
K905679 · ESD
Gn Danavox, Inc.
Ear, Nose, Throat · 40d
Cleared Jan 28, 1991
143 SERIES BTE
K905692 · ESD
Gn Danavox, Inc.
Ear, Nose, Throat · 40d
Cleared Jan 28, 1991
SEROMA-CATH CLOSE DRAINAGE SYSTEM
K905733 · GCY
Dawn Medical
General & Plastic Surgery · 35d
Cleared Jan 28, 1991
FULL VIEW OMEGA TABLE
K905827 · IYX
Med-Tron Products, Inc.
Radiology · 28d
Cleared Jan 28, 1991
ELECTONE BTE MODEL AM 240 PPI
K910098 · ESD
Electone, Inc.
Ear, Nose, Throat · 19d
Cleared Jan 28, 1991
NMR-K FUNDUS LASER LENS
K910231 · HJK
Ocular Instruments, Inc.
Ophthalmic · 10d
Cleared Jan 25, 1991
PROVOCATIVE SENSITIVITY BALLOON
K901125 · KLA
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 319d
Cleared Jan 25, 1991
ABSORBENT, DISPOSABLE URINARY DRAINAGE BAG
K901320 · KNX
Ep Medical, Inc.
Gastroenterology & Urology · 310d
Cleared Jan 25, 1991
BODYLOG ENHANCED STRESS REDUCTION PACKAGE
K902450 · HCC
Bodylog, Inc.
Neurology · 238d
Cleared Jan 25, 1991
ANTICARDIOLIPIN ANTIBODY TEST SYSTEM
K903531 · GFO
Medical Innovations Corp.
Immunology · 172d
Cleared Jan 25, 1991
RHEUMAGEN ASO T-CONTROL
K904311 · GTQ
Biokit USA, Inc.
Microbiology · 128d
Cleared Jan 25, 1991
COAG-1 PT-NC TEST CARD
K904325 · GJS
Cardiovascular Diagnostic Services
Hematology · 127d
Cleared Jan 25, 1991
PREMIER-CRYPTOCOCCAL ANTIGEN
K904393 · MDU
Meridian Diagnostics, Inc.
Microbiology · 122d
Cleared Jan 25, 1991
QUANTIMETRIX QUAN TEST-RED PROTEIN ASSAY SYSTEM
K904603 · CEK
Quantitative Medicine, Inc.
Chemistry · 107d
Cleared Jan 25, 1991
DUAL AND SINGLE IRR. SYSTEMS MODELS 29550 & 29555
K904850 · EFS
Micro Motors, Inc.
Dental · 88d
Cleared Jan 25, 1991
DUODERM DRESSINGS, CGF DRESSINGS, PASTE FULL THICK
K904852 · FRO
Convatec, A Division of E.R. Squibb &...
General & Plastic Surgery · 88d
Cleared Jan 25, 1991
DISPOSABLE FIBER OPTIC DELIVERY SYSTEM
K904911 · GEX
Fiber Delivery Concepts, Inc.
General & Plastic Surgery · 86d
Cleared Jan 25, 1991
BIPOLAR BIOPSY FORCEPS
K904985 · KGE
Everest Medical Corp.
Gastroenterology & Urology · 84d
Cleared Jan 25, 1991
LAPAROSCOPIC ELECTROSURGICAL DEVICE
K904993 · GEI
Everest Medical Corp.
General & Plastic Surgery · 79d