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
28777–28800 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 20, 2017
Compex Sport Elite
K170918 · NGX
Djo, LLC
Physical Medicine · 83d
Cleared Jun 19, 2017
Möller Medical Biopsy Needles and Systems
K162588 · KNW
Moller Medical GmbH
Gastroenterology & Urology · 276d
Cleared Jun 19, 2017
Smith & Nephew, Inc. R3™ Constrained Liner
K162641 · KWZ
Smith & Nephew, Inc.
Orthopedic · 270d
Cleared Jun 19, 2017
ImmuLisa Enhanced B2GP1 IgA Antibody ELISA, ImmuLisa Enhanced B2GP1 IgG...
K162788 · MSV
Immco Diagnostics, Inc.
Immunology · 259d
Cleared Jun 19, 2017
DEKA MOTUS AX
K162886 · GEX
El.En Electronic Engineering Spa
General & Plastic Surgery · 245d
Cleared Jun 19, 2017
Hydris™ Oral Rinse
K163029 · LFD
Biopharm Consult, LLC
Dental · 231d
Cleared Jun 19, 2017
Coalesce™ (-Straight, -Convex, -Crescent, -Lateral, -Anterior, or -Oblique)...
K163506 · MAX
Vertera, Inc.
Orthopedic · 187d
Cleared Jun 19, 2017
Insulia Diabetes Management Companion
K170669 · NDC
Voluntis Sa.
General Hospital · 105d
Cleared Jun 19, 2017
Phantom Small Bone Intramedullary Nail System
K170693 · KTW
Paragon 28, Inc.
Orthopedic · 104d
Cleared Jun 19, 2017
Materialise Glenoid Positioning System
K170893 · KWS
Materialise NV
Orthopedic · 84d
Cleared Jun 19, 2017
Compex Wireless USA
K170903 · NGX
Djo, LLC
Physical Medicine · 83d
Cleared Jun 16, 2017
A1C EZ Glycohemoglobin Analysis System
K161533 · LCP
Biohermes Co., Ltd.
Chemistry · 379d
Cleared Jun 16, 2017
DORA Tubing Sets for Hemodialysis
K161582 · FJK
Bain Medical Equipment (Guangzhou)...
Gastroenterology & Urology · 373d
Cleared Jun 16, 2017
Aortic Arch Cannulae, Optiflow Aortic Arch Cannulae
K162215 · DWF
Sorin Group Italia S.R.L.
Cardiovascular · 312d
Cleared Jun 16, 2017
Diode Laser Hair Removal System
K162659 · GEX
Shandong Huamei Technology Co., Ltd.
General & Plastic Surgery · 263d
Cleared Jun 16, 2017
BioPro Foot Plating Systems
K162674 · HRS
Biopro, Inc.
Orthopedic · 263d
Cleared Jun 16, 2017
Silhouette InstaLift
K163676 · GAM
Silhouette Lift, Inc.
General & Plastic Surgery · 171d
Cleared Jun 16, 2017
Green16/Green18 (Model: PHT-65LHS)
K170066 · OAS
VATECH Co., Ltd.
Radiology · 158d
Cleared Jun 16, 2017
SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque...
K170191 · MCW
Medtronic Vascular, Inc.
Cardiovascular · 144d
Cleared Jun 16, 2017
Reprocessed SoundStar 3D Diagnostic Ultrasound Catheter
K170474 · OWQ
Innovative Health, LLC
Cardiovascular · 120d
Cleared Jun 16, 2017
Alians Fragment Specific
K170843 · HRS
Newclip Technics
Orthopedic · 87d
Cleared Jun 16, 2017
Infinix INFX-8000V, V6.40
K170909 · OWB
Toshiba Medical Systems Coroporation
Radiology · 80d
Cleared Jun 16, 2017
Quantum TTC Biliary Balloon Dilator
K171223 · FGE
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 51d
Cleared Jun 16, 2017
MagVita TMS Therapy System
K171481 · OBP
Tonica Elektronik A/S
Neurology · 28d