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

Filters: Cleared only ×
175,820 results
35473–35496 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 30, 2015
CENTRAL MONITORING SYSTEM
K143695 · HGM
Edan Instruments, Inc.
Obstetrics & Gynecology · 96d
Cleared Mar 30, 2015
Biomet Proximal Humerus Plating System
K143697 · HRS
Biomet Manufacturing
Orthopedic · 96d
Cleared Mar 30, 2015
Site-Rite Prevue Ultrasound System, Site-Rite Prevue+ Ultrasound System
K150529 · IYO
C.R. Bard, Inc.
Radiology · 28d
Cleared Mar 30, 2015
GORE SEAMGUARD Reinforcement
K150551 · OXC
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 26d
Cleared Mar 29, 2015
eMotion Faros ECG Mobile
K143032 · DXH
Mega Electronics , Ltd.
Cardiovascular · 158d
Cleared Mar 29, 2015
Scenium
K150192 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 60d
Cleared Mar 27, 2015
FLEXTIP PLUS EPIDURAL CATHETER
K140110 · BSO
Teleflex, Inc.
Anesthesiology · 436d
Cleared Mar 27, 2015
WestTec Procedure Facemask
K141085 · FXX
Westtec, LLC
General Hospital · 333d
Cleared Mar 27, 2015
ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER
K141322 · PNO
Cook Incorporated
Cardiovascular · 311d
Cleared Mar 27, 2015
DEPUY SYNTHES INJECTABLE POLYMER SYSTEM (IPS)
K141385 · HBW
Depuy Synthes Companies of Johnson &...
Neurology · 304d
Cleared Mar 27, 2015
Patient Positioning Devices
K142420 · IYE
Macromedics BV
Radiology · 211d
Cleared Mar 27, 2015
EBI External Implant System
K142426 · DZE
Ebi, Inc.
Dental · 210d
Cleared CT Mar 27, 2015
MALDI Biotyper CA System
K142677 · PEX
Bruker Daltonics, Inc.
Microbiology · 189d
Cleared Mar 27, 2015
samaritan PAD 450P
K142709 · MKJ
Heartsine Technologies, Inc.
Cardiovascular · 186d
Cleared Mar 27, 2015
HealthGuard-15
K143108 · DXN
Futrex, Inc.
Cardiovascular · 149d
Cleared Mar 27, 2015
F3
K143180 · ITI
Permobil AB
Physical Medicine · 143d
Cleared Mar 27, 2015
Voyant Open Sealer-Divider Device
K143517 · GEI
Applied Medical Resources
General & Plastic Surgery · 105d
Cleared Mar 27, 2015
Gyrus ACMI - EZDilate 3-Stage Balloon Dilatation Catheter
K143609 · FGE
Olympus Surgical Technologies America
Gastroenterology & Urology · 98d
Cleared Mar 27, 2015
NuVasive NVM5 System
K143641 · PDQ
Nu Vasive, Incorporated
Neurology · 95d
Cleared Mar 27, 2015
1717SGN / 1717SCN Digital Flat Panel X-ray Detector
K150150 · MQB
Rayence Co., Ltd.
Radiology · 63d
Cleared Mar 27, 2015
TYRX Neuro Absorbable Antibacterial Envelope
K150291 · FTL
Medtronic Tyrx, Inc.
General & Plastic Surgery · 49d
Cleared Mar 27, 2015
SOFIA 6F Catheter
K150366 · DQY
MicroVention, Inc.
Cardiovascular · 43d
Cleared Mar 26, 2015
AVANCE FOAM DRESSING KITS
K141847 · OMP
Molnlycke Health Care Us, LLC
General & Plastic Surgery · 260d
Cleared Mar 26, 2015
GENADYNE SPIRO FOAM DRESSING KIT
K141961 · OMP
Genadyne Biotechnologies, Inc.
General & Plastic Surgery · 251d