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
21649–21672 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Nov 01, 2019
XIHPOS™ ZFUZE™ Interbody Fusion System
K190544 · MAX
Difusion Technologies
Orthopedic · 242d
Cleared Nov 01, 2019
BD Acute Central Line
K190855 · FOZ
Bard Access Systems, Inc. (Bard Has...
General Hospital · 213d
Cleared CT Nov 01, 2019
Sight OLO
K190898 · GKZ
Sight Diagnostics , Ltd.
Hematology · 210d
Cleared Nov 01, 2019
COPAL exchange G Hip and Knee Spacers
K191016 · KWY
Heraeus Medical GmbH
Orthopedic · 198d
Cleared Nov 01, 2019
Perfect PFE
K191312 · KPI
Tenscare, Ltd.
Gastroenterology & Urology · 170d
Cleared Nov 01, 2019
NextDent Denture 3D+
K191497 · EBI
Vertex-Dental B.V.
Dental · 149d
Cleared Nov 01, 2019
Stealth Autoguide System, Midas Rex Legend Depth Stop System
K191597 · HAW
Medtronic Navigation, Inc.
Neurology · 137d
Cleared Nov 01, 2019
Delta Multihole TT Pro Acetabular System
K191622 · LPH
Lima Corporate S.P.A.
Orthopedic · 136d
Cleared Nov 01, 2019
ZMAXX Dental Zirconia Blanks
K191631 · EIH
Zmaxx Bioceramics, LLC
Dental · 135d
Cleared Nov 01, 2019
LEGION System
K191650 · HQC
Alcon Research, LLC
Ophthalmic · 134d