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
21625–21648 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 06, 2019
Arthrex Nano SwiveLock Suture Anchor
K191651 · HWC
Arthrex, Inc.
Orthopedic · 139d
Cleared Nov 06, 2019
SOMATOM X.cite
K191891 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 114d
Cleared Nov 06, 2019
Thermo Scientific Sensititre ARIS HiQ System
K191914 · LRG
Thermo Fisher Scientific
Microbiology · 112d
Cleared Nov 06, 2019
Thermo Scientific Sensititre ARIS HiQ System
K191918 · LRG
Thermo Fisher Scientific
Microbiology · 111d
Cleared Nov 06, 2019
Conformis Hip System
K192198 · LPH
Conformis, Inc.
Orthopedic · 85d
Cleared Nov 06, 2019
Sensititre 18-24 Hour MIC or Breakpoint Susceptibility System with Lefamulin...
K192729 · JWY
Thermo Fisher Scientific
Microbiology · 40d
Cleared Nov 05, 2019
Zimmer Biomet 12/14 CoCr Femoral Head and Freedom Head
K183457 · LPH
Zimmer, Inc.
Orthopedic · 327d
Cleared Nov 05, 2019
MucoPEG
K190144 · LFD
Sunbio, Inc.
Dental · 280d
Cleared Nov 05, 2019
TAP Blood Collection Device
K190225 · PRJ
Seventh Sense Biosystems, Inc.
Chemistry · 273d
Cleared Nov 05, 2019
MTS225 and MTS300 Multiple Tray Sterilization Systems
K190541 · KCT
Pmbs, LLC
General Hospital · 246d
Cleared Nov 05, 2019
Cleerly Labs
K190868 · LLZ
Cleerly, Inc.
Radiology · 216d
Cleared Nov 05, 2019
ADI TiDAL Osteotomy Wedge
K191047 · PLF
Additive Device, Inc. (Adi) D/B/A...
Orthopedic · 200d
Cleared Nov 05, 2019
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
K191292 · LYZ
Anhui Powerguard Technology Co., Ltd.
General Hospital · 175d
Cleared Nov 05, 2019
iASSIST Knee System
K192080 · OLO
Orthosoft Inc. (d/b/a) Zimmer CAS
Orthopedic · 95d
Cleared Nov 05, 2019
KOALA
K192109 · LLZ
Ib Lab GmbH
Radiology · 92d
Cleared Nov 05, 2019
7D Surgical System
K192140 · OLO
7D Surgical, Inc.
Orthopedic · 89d
Cleared Nov 05, 2019
Fitmore Hip Stem
K192236 · KWY
Zimmer GmbH
Orthopedic · 78d
Cleared Nov 05, 2019
A1AT Genotyping Test
K192858 · PZH
Progenika Biopharma S.A., A Grifols...
Immunology · 32d
Cleared Nov 05, 2019
Suglue 3
K192992 · EMA
3M Deutschland GmbH
Dental · 11d
Cleared Nov 04, 2019
WellDoc BlueStar
K190013 · MRZ
Welldoc, Inc.
General Hospital · 305d
Cleared Nov 04, 2019
LARS AC Band Device
K190143 · HTN
Corin USA
Orthopedic · 279d
Cleared Nov 04, 2019
DRX-Evolution/Plus with Dual Energy
K190330 · KPR
Carestream Health, Inc.
Radiology · 263d
Cleared Nov 04, 2019
Mei Ceramic Bracket
K190608 · NJM
Orthosun Co., Ltd.
Dental · 238d
Cleared Nov 04, 2019
xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS...
K191160 · PCH
Luminex Molecular Diagnostics, Inc.
Microbiology · 187d