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
22897–22920 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 04, 2019
KOWA DR-1a
K190573 · HKI
Kowa Company , Ltd.
Ophthalmic · 90d
Cleared Jun 04, 2019
TD-4183 Blood Glucose Monitoring System
K190579 · NBW
Taidoc Technology Corporation
Chemistry · 90d
Cleared Jun 04, 2019
MectaScrew PEEK Interference Screw
K190892 · MBI
Medacta International S.A.
Orthopedic · 60d
Cleared Jun 04, 2019
CORTRAK* 2 Equilateral Enteral Access System
K191340 · KNT
Avanos Medical, Inc.
Gastroenterology & Urology · 15d
Cleared Jun 03, 2019
Sterilizable Internal Defibrillation Paddles for use with LIFEPAK...
K182503 · LDD
Physio-Control, Inc.
Cardiovascular · 264d
Cleared Jun 03, 2019
Diapex Plus
K182625 · KIF
DiaDent Group International
Dental · 252d
Cleared CT Jun 03, 2019
ReWalk Restore
K190337 · PHL
Re Walk Robotics , Ltd.
Neurology · 109d
Cleared Jun 03, 2019
Solanas® Posterior OCT Fixation System
K191185 · NKG
Alphatec Spine
Orthopedic · 31d
Cleared Jun 02, 2019
Rightest Blood Glucose Monitoring System GM700S, Rightest Blood Glucose...
K190564 · NBW
Bionime Corporation
Chemistry · 89d
Cleared Jun 01, 2019
Erchonia FX-635
K190572 · NHN
Erchonia Corporation
Physical Medicine · 87d
Cleared May 31, 2019
Pristine Hemodialysis Catheter
K182443 · MSD
Pristine Access Technologies , Ltd.
Gastroenterology & Urology · 266d
Cleared May 31, 2019
Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology MR Labeling
K182678 · LPH
Zimmer, Inc.
Orthopedic · 247d
Cleared May 31, 2019
Apis
K182725 · FRO
Sweetbio, Inc.
General & Plastic Surgery · 245d
Cleared May 31, 2019
C2 CryoBalloon Catheter (Pear), C2 CryoBalloon (Standard), C2 CryoBalloon...
K190194 · GEH
Pentax Medical, A Division of Pentax...
General & Plastic Surgery · 116d
Cleared May 31, 2019
Tiger Sharps Containers
K190240 · MMK
International Marketing Specialists,...
General Hospital · 114d
Cleared May 31, 2019
NeuroShield
K190246 · JXI
Monarch Bioimplants GmbH
Neurology · 114d
Cleared May 31, 2019
U Deliver Bolink ENFit Enteral Feeding Sets
K190310 · PIF
U Deliver Medical, LLC
Gastroenterology & Urology · 108d
Cleared May 31, 2019
Cannulated Hemi Implant
K190543 · KWD
Vilex IN Tennessee, Inc.
Orthopedic · 88d
Cleared May 31, 2019
NEXXT MATRIXX Stand Alone Cervical System
K190546 · OVE
Nexxt Spine, LLC
Orthopedic · 87d
Cleared May 31, 2019
Cervical Plate
K190565 · KWQ
Eisertech, LLC
Orthopedic · 87d
Cleared May 31, 2019
MAGNETOM Avanto Fit
K190757 · LNH
Siemens Medical Solution USA, Inc.
Radiology · 67d
Cleared May 31, 2019
PALACOS fast R+G
K190766 · LOD
Heraeus Medical GmbH
Orthopedic · 67d
Cleared May 31, 2019
E240AG LCD Monitor, E240A LCD Monitor, JUSHA-E240AG LCD Monitor, JUJSHA-E240A...
K190831 · GCJ
Nanjing Jusha Display Technology Co.,...
General & Plastic Surgery · 60d
Cleared May 31, 2019
BriefCase
K190896 · QAS
Aidoc Medical , Ltd.
Radiology · 56d