Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
34393–34416 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 31, 2015
OCS-B COLLAGEN
K142040 · NPM
Nibec Co., Ltd.
Dental · 368d
Cleared Jul 31, 2015
Biogensis Implant System-Kisses
K142813 · DZE
Biogenesis Co., Ltd.
Dental · 305d
Cleared Jul 31, 2015
NIRO-200NX
K143219 · MUD
Hamamatsu Photonics K.K.
Cardiovascular · 263d
Cleared Jul 31, 2015
STRONG Dental Handpieces
K143418 · EGS
Saeshin Precision Co., Ltd.
Dental · 245d
Cleared Jul 31, 2015
Durex Silicone
K143532 · NUC
Reckitt Benckiser, LLC
Obstetrics & Gynecology · 231d
Cleared Jul 31, 2015
B40i Patient Monitor
K143676 · MHX
GE Healthcare Finland Oy
Cardiovascular · 219d
Cleared Jul 31, 2015
Z5m(t)
K150021 · DZE
Z-Systems AG
Dental · 206d
Cleared Jul 31, 2015
Unimicro Veress Needle
K150068 · HIF
Unimicro Medical Systems (Shenzhen)...
Obstetrics & Gynecology · 199d
Cleared Jul 31, 2015
OneTouch Verio Flex Blood Glucose Monitoring System
K150214 · NBW
Lifescan Europe
Chemistry · 182d
Cleared Jul 31, 2015
MagVita TMS Therapy System
K150641 · OBP
Tonica Elektronik A/S
Neurology · 142d
Cleared Jul 31, 2015
GME ExSys 308
K150752 · FTC
Gme (German Medical Engineering) GmbH
General & Plastic Surgery · 130d
Cleared Jul 31, 2015
NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector)
K150874 · FMF
Novo Nordisk, Inc.
General Hospital · 121d
Cleared Jul 31, 2015
PSPIX 2 scanner, Imaging Plate Size 0 for PSPIX2 scanner, Imaging Plate Size...
K151053 · MUH
Sopro - Acteon Group
Radiology · 102d
Cleared Jul 31, 2015
HEMO-Bandage
K151204 · QSY
Coreleader Biotech Co., Ltd.
General & Plastic Surgery · 87d
Cleared Jul 31, 2015
Zephyr Vascular Compression Device
K151363 · DXC
Advanced Vascular Dynamics
Cardiovascular · 71d
Cleared Jul 31, 2015
Biomet Spine Fusion System
K151483 · MAX
Biomet Spine, LLC
Orthopedic · 59d
Cleared Jul 31, 2015
Arthrex OrthoVis Preoperative Plan
K151568 · LLZ
Custom Orthopaedic Solutions, Inc.
Radiology · 51d
Cleared Jul 31, 2015
Sniper Spine System
K151813 · MNI
Spine Wave, Inc.
Orthopedic · 29d
Cleared Jul 31, 2015
SyncVision System
K151904 · OWB
Volcano Corporation
Radiology · 18d
Cleared Jul 31, 2015
SmartSite Vented Vial Access Device
K151963 · LHI
Yukon Medical, LLC
General Hospital · 15d
Cleared Jul 30, 2015
OneTouch Lubricant Gel
K142790 · NUC
Thai Nippon Rubber Industry Co., Ltd.
Obstetrics & Gynecology · 307d
Cleared Jul 30, 2015
Polypectomy Snare
K150316 · FDI
Micro-Tech (Nanjing) Co., Ltd.
Gastroenterology & Urology · 171d
Cleared Jul 30, 2015
Diros OWL Sterile Single Use TridentTM R.F. Insulated Cannulae,Models DTR and...
K150371 · GXI
Diros Technology, Inc.
Neurology · 167d
Cleared Jul 30, 2015
XenMatrix AB Surgical Graft
K151177 · PIJ
C. R. Bard
General & Plastic Surgery · 90d