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
33001–33024 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 22, 2016
FD TENS 2090, FD TENS 2095
K152676 · GZJ
Fuji Dynamics , Ltd.
Neurology · 126d
Cleared Jan 22, 2016
Mepiseal Soft Silicone Sealant
K152741 · OMP
Molnlycke Health Care Us, LLC
General & Plastic Surgery · 121d
Cleared Jan 22, 2016
Ponto Bone Anchored Hearing System
K152820 · MAH
Oticon Medical AB
Ear, Nose, Throat · 116d
Cleared Jan 22, 2016
Crosstella RX Balloon Dilatation Catheter
K152873 · LIT
KANEKA Corporation
Cardiovascular · 114d
Cleared Jan 22, 2016
Crosperio RX PTA Balloon Dilatation Catheter
K152887 · LIT
KANEKA Corporation
Cardiovascular · 114d
Cleared Jan 22, 2016
MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES)
K153594 · HCG
MicroVention, Inc.
Neurology · 37d
Cleared Jan 22, 2016
Stryker Neptune E-SEP Smoke Evacuation Pencil
K153679 · GEI
Stryker Corporation
General & Plastic Surgery · 32d
Cleared Jan 21, 2016
Shape-HF Cardiopulmonary Testing System
K150888 · BTY
Shape Medical Systems, Inc.
Anesthesiology · 294d
Cleared Jan 21, 2016
AirLife Infant Heated Wire Circuit
K151303 · BZE
Care Fusion
Anesthesiology · 248d
Cleared Jan 21, 2016
Carestation 620/650/650C
K151570 · BSZ
Datex-Ohmeda, Inc.
Anesthesiology · 225d
Cleared Jan 21, 2016
Cajun Commando 4x4
K152672 · ITI
Lil Critter, LLC
Physical Medicine · 125d
Cleared Jan 21, 2016
Grasping Forceps
K152802 · OCZ
Micro-Tech (Nanjing) Co., Ltd.
Gastroenterology & Urology · 115d
Cleared Jan 21, 2016
DeVilbiss DV6WM Wireless Modem
K152810 · BZD
Devilbiss Healthcare, LLC
Anesthesiology · 115d
Cleared Jan 21, 2016
Pruitt F3-S Polyurethane Carotid Shunt
K152833 · MJN
LeMaitre Vascular, Inc.
Cardiovascular · 114d
Cleared Jan 21, 2016
AQUACEL Ag Surgical SP Dressing
K152926 · FRO
Convatec Limited
General & Plastic Surgery · 108d
Cleared Jan 21, 2016
aap LOQTEQ VA Radius Set 2.5
K153034 · HRS
Aap Implantate AG
Orthopedic · 94d
Cleared Jan 21, 2016
Corin Metafix Hip Stem
K153381 · LZO
Corin U.S.A. Limited
Orthopedic · 59d
Cleared Jan 21, 2016
Discovery NM/CT 670 CZT
K153402 · KPS
Ge Healthcare
Radiology · 58d
Cleared Jan 21, 2016
HI VISION ASCENDUS, HV ASCENDUS, ASCENDUS
K153421 · IYN
Hitachi Aloka Medical America, Inc.
Radiology · 57d
Cleared Jan 21, 2016
Biomet Spine Fusion System
K153695 · MAX
Biomet Spine, LLC
Orthopedic · 29d
Cleared Jan 21, 2016
Release Laminoplasty Fixation System
K153735 · NQW
Pioneer Surgical Technology, Inc....
Orthopedic · 24d
Cleared Jan 20, 2016
Desyncra for Tinnitus Therapy System, Desyncra for Tinnitus Pro System
K151558 · KLW
Neurotherapies Reset GmbH
Ear, Nose, Throat · 224d
Cleared Jan 20, 2016
Firefly Peritoneal Dialysis Connector Disinfection System
K151620 · KDJ
Puracath Medical, Inc.
Gastroenterology & Urology · 218d
Cleared Jan 20, 2016
AVS AL and AVS ALign PEEK Spacers, AVS PL and AVS UniLIF PEEK Spacers, AVS...
K151726 · MAX
Stryker Corporation
Orthopedic · 208d