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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
85897–85920 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Apr 29, 1999
QUINTON MEDTRACK CR PLUS TREADMILL
K990866 · ISD
Quinton, Inc.
Physical Medicine · 44d
Cleared Apr 29, 1999
FERRIS POLYMEM POLYWIC STERILE CAVITY WOUND FILLER
K990906 · KMF
Ferris Mfg. Corp.
General & Plastic Surgery · 42d
Cleared Apr 29, 1999
EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM
K991092 · KWQ
Electro-Biology, Inc.
Orthopedic · 28d
Cleared Apr 29, 1999
SOFT TISSUE SUTURE WASHER
K991135 · HTN
Depuy, Inc.
Orthopedic · 24d
Cleared Apr 29, 1999
HI-TORQUE BALANCE TREK GUIDE WIRE
K991152 · DQX
Guidant Corp.
Cardiovascular · 23d
Cleared Apr 29, 1999
HYDRO-CAST ACRYLIC VARNISH, MODEL 78125
K991161 · EIA
Kay See Dental Mfg. Co.
Dental · 22d
Cleared Apr 28, 1999
WATER TREATMENT SYSTEM FOR HEMODIALYSIS
K983512 · FIP
Water Vault, Inc.
Gastroenterology & Urology · 203d
Cleared Apr 28, 1999
TRINITY II SINGLE CHAMBER DVT PUMP
K983680 · JOW
Delphi Consulting Group
Cardiovascular · 190d
Cleared Apr 28, 1999
STAINLESS STEEL NONABSORBABLE SURGICAL SUTURE, USP
K984151 · GAQ
Mill Pond, Inc.
General & Plastic Surgery · 160d