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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
21049–21072 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Nov 04, 2019
EthanZir Zirconia
K191304 · EIH
Besorah Dental Solutions NZ Limited
Dental · 174d
Cleared Nov 04, 2019
Scan Abutments and Comfort Caps
K191634 · NHA
Dentium Co., Ltd.
Dental · 138d
Cleared Nov 04, 2019
Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear Pen
K192125 · OCL
AtriCure, Inc.
Cardiovascular · 90d
Cleared Nov 04, 2019
Idys ALIF ZP 3DTi
K192168 · OVD
Clariance, Sas
Orthopedic · 87d
Cleared Nov 03, 2019
NuVasive AttraX Putty
K191974 · MQV
Nu Vasive, Incorporated
Orthopedic · 102d
Cleared Nov 02, 2019
Allcem, Allcem Core
K183465 · EMA
Dentscare Ltda
Dental · 323d
Cleared Nov 02, 2019
Parcus Knotless AP Suture Anchors
K192824 · MAI
Parcus Medical, LLC
Orthopedic · 31d
Cleared Nov 01, 2019
STURDY Autoclave Super Microm (models SA-260MA and SA-260MA-R)
K181993 · FLE
Sturdy Industrial Co., Ltd.
General Hospital · 463d
Cleared Nov 01, 2019
VPro5
K183018 · OYH
Propel Orthodontics, LLC
Dental · 366d
Cleared Nov 01, 2019
Foryou NPWT Dressing Kit
K190119 · OMP
4l Health Co., Ltd.
General & Plastic Surgery · 281d
Cleared Nov 01, 2019
MDT2 BLE Self-Monitoring Blood Glucose System
K190189 · NBW
Eps Bio Technology Corp.
Chemistry · 273d
Cleared Nov 01, 2019
WV1 Endoscope
K190190 · HET
270surgical , Ltd.
Obstetrics & Gynecology · 273d
Cleared Nov 01, 2019
MIMOSA Imager
K190334 · MUD
Mimosa Diagnostics, Inc.
General & Plastic Surgery · 260d
Cleared Nov 01, 2019
DePuy Corail AMT Hip Prosthesis
K190344 · LZO
Depuy(Ireland)
Orthopedic · 260d