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
86401–86424 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 30, 1999
SPIROVIT, MODEL SP-250
K984031 · BZG
Schiller AG
Anesthesiology · 169d
Cleared Apr 30, 1999
HP M2376A DEVICE LINK SYSTEM
K984194 · MQS
Hewlett-Packard Co.
Gastroenterology & Urology · 158d
Cleared Apr 30, 1999
OSTEONICS SPINAL SYSTEM - SACRAL OFFSET CONNECTOR ASSEMBLY
K984375 · KWP
Osteonics Corp.
Orthopedic · 144d
Cleared Apr 30, 1999
AU6
K990360 · IYN
Biosound Esaote, Inc.
Radiology · 84d
Cleared Apr 30, 1999
B2C, ESPACE REVISION CUP SYSTEM
K990523 · LPH
Turnkey Intergration USA, Inc.
Orthopedic · 70d
Cleared Apr 30, 1999
ORTHOPHOS 3/3 CEPH/3 DS
K990528 · MUH
Sirona Dental Systems GmbH
Radiology · 70d
Cleared Apr 30, 1999
CORDIA PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND DELIVERY SYSTEM,...
K990631 · FGE
Cordis Corp.
Gastroenterology & Urology · 63d
Cleared Apr 30, 1999
GUIDANT MEGALINK BILIARY STENT, MODEL FG1002949-58
K991032 · FGE
Guidant Corp.
Gastroenterology & Urology · 32d
Cleared Apr 30, 1999
ABSORBABLE SURGICAL GUT SUTURE, PLAIN AND CHRONIC AND SOFTCAT ABSORBABLE...
K991223 · GAL
Aesculap, Inc.
General & Plastic Surgery · 18d
Cleared Apr 29, 1999
BUECHEL-PAPPAS MODULAR SALVAGE STEM
K982418 · MJT
Endotec, Inc.
Orthopedic · 290d
Cleared Apr 29, 1999
ROTORBLADE
K983435 · MAI
Li Medical Technologies, Inc.
Orthopedic · 212d
Cleared Apr 29, 1999
ENDOPEARL
K984171 · MAI
Linvatec Corp.
Orthopedic · 160d
Cleared Apr 29, 1999
SPECTRA VU 1000 SERIES INTRAORAL CAMERA, SPECTRA VU 2000 SERIES INTRAORAL...
K984332 · EIA
International Technology Concepts
Dental · 147d
Cleared Apr 29, 1999
IN TOUCH DIABETES MANAGEMENT SOFTWARE
K984527 · CGA
Lifescan, Inc.
Chemistry · 129d
Cleared Apr 29, 1999
KENSTONE
K990139 · IOR
Kenda USA
Physical Medicine · 100d
Cleared Apr 29, 1999
EBI OMEGA 21 SYSTEM
K990303 · KWP
Electro-Biology, Inc.
Orthopedic · 87d
Cleared Apr 29, 1999
THE BAGNOLI-8 EMG SYSTEM
K990356 · HCC
Delsys, Inc.
Neurology · 83d
Cleared Apr 29, 1999
ORLIGHT 2000 SURGICAL LASER SYSTEM
K990452 · GEX
Ybeam Technologies, Inc.
General & Plastic Surgery · 76d
Cleared Apr 29, 1999
DISTAL RADIUS FRACTURE FIXATION PLATE SYSTEM
K990596 · HRS
Avanta Orthopaedics, Inc.
Orthopedic · 64d
Cleared Apr 29, 1999
BOLD SCREW
K990622 · HWC
New Deal, S.A.
Orthopedic · 63d
Cleared Apr 29, 1999
OPTICAL TRACKING SYSTEM (OTS)
K990632 · HAW
Radionics, Inc.
Neurology · 62d
Cleared Apr 29, 1999
AAP CANNULATED SCREW, 7.5MM, 4.5MM, 4.0MM, 3.5MM, 7.0MM
K990776 · HWC
Aap Implantate AG
Orthopedic · 51d
Cleared Apr 29, 1999
STAYFUSE
K990804 · HWC
Pioneer Surgical Technology
Orthopedic · 50d
Cleared Apr 29, 1999
PROVIDENCE CUP SYSTEM
K990821 · JDI
Biopro, Inc.
Orthopedic · 49d