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
30649–30672 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 14, 2016
Vital Sync Informatics Manager & Virtual Patient Monitoring Platform
K160718 · MWI
Covidien
Cardiovascular · 244d
Cleared Nov 14, 2016
ThermoPro
K161862 · IMJ
Zimmer Medizinsysteme GmbH
Physical Medicine · 131d
Cleared Nov 14, 2016
FasTouch Fixation System
K162252 · GDW
Via Surgical , Ltd.
General & Plastic Surgery · 96d
Cleared Nov 14, 2016
Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit
K162457 · PNG
Rocket Medical Plc
Gastroenterology & Urology · 73d
Cleared Nov 14, 2016
Ligasure Blunt Tip, Sealer/Divider, Nano-coated
K162941 · GEI
Covidien
General & Plastic Surgery · 24d
Cleared Nov 10, 2016
rainbow Shine
K160079 · EIH
Genoss Co., Ltd.
Dental · 301d
Cleared Nov 10, 2016
iCodeConnect
K160127 · BZD
3B Medical, Inc.
Anesthesiology · 295d
Cleared Nov 10, 2016
Sunmed Control Syringes
K160190 · DXT
Sunny Medical Device (Shenzhen) Co.,...
Cardiovascular · 288d
Cleared Nov 10, 2016
Calprest NG
K160447 · NXO
Eurospital S.P.A.
Immunology · 267d
Cleared Nov 10, 2016
DePuy Synthes MAXFRAME Multi-Axial Correction System
K161417 · KTT
Synthes (Usa), LLC
Orthopedic · 171d
Cleared Nov 10, 2016
Prontosan Wound Irrigation Solution, 40 mL, Prontosan Wound Irrigation...
K161623 · FRO
B.Braun Medical, Inc.
General & Plastic Surgery · 150d
Cleared Nov 10, 2016
JAS Pulse(TM) Ultrasonic Therapy
K161628 · IMI
Bonutti Research, Inc.
Physical Medicine · 150d
Cleared Nov 10, 2016
IPS CaseDesigner
K161634 · LLZ
Nobel Biocare AB
Radiology · 149d
Cleared Nov 10, 2016
FORA ADVANCED GD40 and FORA ADVANCED GD40 pro Blood Glucose and ß-Ketone...
K161738 · NBW
Taidoc Technology Corporation
Chemistry · 140d
Cleared Nov 10, 2016
i-CAT FLX V series / KaVo 3D eXam+ V series
K162085 · OAS
Imaging Sciences International
Radiology · 106d
Cleared Nov 10, 2016
XBraid TT Suture Tape
K162310 · GAT
Stryker
General & Plastic Surgery · 85d
Cleared CT Nov 10, 2016
Solitaire 2 Revascularization Device
K162539 · POL
Micro Therapeutics, Inc. d/b/a ev3...
Neurology · 59d
Cleared Nov 10, 2016
FORTEZZA Spinal Stabilization System
K162576 · NKB
Osso Surgical
Orthopedic · 56d
Cleared Nov 10, 2016
ESU-1 Electrosurgical Generator
K162656 · GEI
Tva Medical, Inc.
General & Plastic Surgery · 48d
Cleared Nov 09, 2016
HYPNOSPAD
K152660 · LRK
Somnics, Inc.
Dental · 419d
Cleared Nov 09, 2016
Vivo 60
K160481 · NOU
Breas Medical AB
Anesthesiology · 261d
Cleared Nov 09, 2016
Insulia Diabetes Management Companion
K161433 · NDC
Voluntis Sa.
General Hospital · 169d
Cleared Nov 09, 2016
EXPRT Revision Hip System
K161610 · KWZ
Encore Medical, L.P.
Orthopedic · 152d
Cleared Nov 09, 2016
Virtu C Spinal Implant System
K161649 · ODP
Met 1 Technologies, LLC
Orthopedic · 147d