FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
91753–91776 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 20, 1997
AUTODELFIA NEONATAL HTSH L KIT (B077-112)
K973276 · JLW
Eg &G Wallac
Chemistry · 79d
Cleared Nov 20, 1997
S-ROM ZIRCONIA CERAMIC FEMORAL HIP HEAD
K973307 · LZO
Johnson & Johnson Professionals, Inc.
Orthopedic · 78d
Cleared Nov 20, 1997
HOFFMANN II COMPACT PERIARTICULAR CLAMP
K973321 · KTT
Howmedica, Inc.
Orthopedic · 77d
Cleared Nov 20, 1997
TECA DISPOSABLE MONOPOLAR NEEDLE ELECTRODES
K973442 · IKT
Medelec, Inc. D.B.A. Teca Corp.
Neurology · 70d
Cleared Nov 20, 1997
TECA MYOJECT DISPOSABLE NEEDLE ELECTRODES
K973444 · IKT
Medelec, Inc. D.B.A. Teca Corp.
Neurology · 70d
Cleared Nov 20, 1997
CARMEDA COATED CARDIOTHERM BLOOD CARDIOPLEGIA SYSTEMS (CBCTXXX SERIES AND...
K973475 · DTR
Medtronic Vascular
Cardiovascular · 69d
Cleared Nov 20, 1997
VARIABLE PARALLEL PIN
K973521 · DZE
Sulzer Calcitek, Inc.
Dental · 64d
Cleared Nov 20, 1997
NEUROLINE, DISPOSABLE CONCENTRIC NEEDLE ELECTRODES
K973529 · IKT
Medicotest A/S
Neurology · 63d
Cleared Nov 20, 1997
AL-47 (ISOFILCON) SOFT (SPHERICAL) DAILY WEAR CONTACT LENS
K973597 · LPL
Martin Dalsing
Ophthalmic · 59d
Cleared Nov 20, 1997
QUICKIE ZIPPIE SERIES, QUICKIE BREEZY SERIES, QUICK FOLDING SERIES, QUICKIE...
K973673 · IOR
Sunrise Medical, Inc.
Physical Medicine · 55d
Cleared Nov 20, 1997
IMMUNOCHEMISTRY SYSTEM BETA-2-MICROGLOBULIN REAGENT
K973813 · JZG
Beckman Instruments, Inc.
Immunology · 44d
Cleared Nov 20, 1997
VENNETO
K974045 · HQY
Amsure Sports, Inc.
Ophthalmic · 27d
Cleared Nov 19, 1997
GREATBATCH SCIENTIFIC MRI COMPATIBLE FIBER OPTIC LARYNGOSCOPE HANDLE
K970619 · CCW
Wilson Greatbatch Technologies, Inc.
Anesthesiology · 274d
Cleared Nov 19, 1997
G.E.M. WATER SYSTEMS, INTERNATIONAL
K970674 · FIN
G.E.M. Water Systems
Gastroenterology & Urology · 268d
Cleared Nov 19, 1997
KNOTT NG TUBE
K971354 · FEG
Michael M. Knott, M.D.
Gastroenterology & Urology · 222d
Cleared Nov 19, 1997
MEDIMAGE
K972215 · LLZ
Vepro - Computersysteme GmbH
Radiology · 159d
Cleared Nov 19, 1997
BLUE MAX - 20 BALLOON DILATATION CATHETER
K972357 · LIT
Boston Scientific Corp
Cardiovascular · 147d
Cleared Nov 19, 1997
LMI IRRIGATION CATHETER (IGR)
K972623 · DXE
Lucas Medical, Inc.
Cardiovascular · 128d
Cleared Nov 19, 1997
IMATION SE-204 LASER IMAGER
K972822 · LMC
Imation Enterprises Corp.
Radiology · 112d
Cleared Nov 19, 1997
TIMESH TITANIUM MINI-SOFTPLATE AND MICRO-SOFT PLATE/SCREW SYSTEM
K973145 · JEY
Sofamor Danek USA,Inc.
Dental · 89d
Cleared Nov 19, 1997
IMTEC BONE COLLECTOR SYSTEM
K973248 · EHZ
Imtec Corp.
Dental · 82d
Cleared Nov 19, 1997
SKAR-KARE
K973271 · MDA
Target Health, Inc.
General & Plastic Surgery · 78d
Cleared Nov 19, 1997
STABILOR HN
K973288 · EJS
Degussa Corp.
Dental · 78d
Cleared Nov 19, 1997
RENEGADE FIBER BRAIDED MICROCATHETER
K973645 · KRA
Boston Scientific Corp
Cardiovascular · 56d