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
29233–29256 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 02, 2017
Vitoss Bioactive (BA) Injectable
K163621 · MQV
Orthovita, Inc.
Orthopedic · 131d
Cleared CT May 02, 2017
ARIES Bordetella Assay
K163626 · OZZ
Luminex Corporation
Microbiology · 131d
Cleared May 02, 2017
AssureTech Panel Dip Test, AssureTech Quick Cup Test
K170049 · NFT
Assure Tech. (Hangzhou) Co, Ltd.
Toxicology · 117d
Cleared May 02, 2017
Xultan 5.5 Pedicle Screw System
K170108 · NKB
Met One Technologies
Orthopedic · 110d
Cleared May 02, 2017
Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable...
K170141 · GZB
Stimwave Technologies Incorporated
Neurology · 105d
Cleared May 02, 2017
BD MAX Extended Enteric Bacterial Panel, BD MAX System
K170308 · PCH
Becton, Dickinson and Company
Microbiology · 90d
Cleared May 02, 2017
NAVIO
K170360 · OLO
Blue Belt Technologies, Inc.
Orthopedic · 85d
Cleared May 02, 2017
Collagen Meniscus Implant XL
K170364 · OLC
Ivy Sports Medicine, LLC
Orthopedic · 85d
Cleared May 02, 2017
AXIS Image Management System
K171098 · NFJ
Sonomed, Inc.
Ophthalmic · 19d
Cleared May 01, 2017
The Cranial Fusion System
K162266 · NKG
Life Spine, Inc.
Orthopedic · 263d
Cleared May 01, 2017
REDAPT Sleeved Monolithic Revision Stems
K162303 · MEH
Smith & Nephew, Inc.
Orthopedic · 257d
Cleared May 01, 2017
Remel Spectra ESBL
K162620 · JSO
Remel, Inc.
Microbiology · 223d
Cleared May 01, 2017
NuVasive NuvaLine Mobile App
K162647 · LLZ
Nu Vasive, Incorporated
Radiology · 221d
Cleared May 01, 2017
Medline ReNewal Reprocessed Ligasure Curved, Small Jaw Open Sealer/Divider
K162751 · NUJ
Surgical Instrument Services and...
General & Plastic Surgery · 213d
Cleared May 01, 2017
CAPTIVATE™ Compression Screws
K162825 · HWC
Globus Medical, Inc.
Orthopedic · 206d
Cleared May 01, 2017
NaviSuite SSI Edition
K163119 · LLZ
Medcom GmbH
Radiology · 174d
Cleared May 01, 2017
NuVasive CoRoent Ti-C System
K163707 · MAX
Nu Vasive, Incorporated
Orthopedic · 123d
Cleared May 01, 2017
StealthStation S8 Spine Software v1.0.0
K170011 · OLO
Medtronic Navigation
Orthopedic · 118d
Cleared May 01, 2017
MagVita TMS Therapy - w/MagPro R20
K170114 · OBP
Tonica Elektronik A/S
Neurology · 109d
Cleared May 01, 2017
IontoDC
K170291 · EGJ
Soterix Medical, Inc.
Physical Medicine · 90d
Cleared May 01, 2017
VENTRALIGHT ST Mesh with ECHO 2 Positioning System 11cm (4.5”) Circle,...
K170294 · FTL
C. R. Bard
General & Plastic Surgery · 90d
Cleared May 01, 2017
XSTAT 30, 3-Pack
K170334 · PGZ
Revmedx, Inc.
General & Plastic Surgery · 88d
Cleared May 01, 2017
ScanX Intraoral View
K170733 · MUH
Duerr Dental AG
Radiology · 52d
Cleared May 01, 2017
Bovie J-Plasma Precise FLEX Handpiece
K170777 · GEI
Bovie Medical Corporation
General & Plastic Surgery · 47d