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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
61585–61608 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 25, 2006
SURGICAL DRAPES
K061422 · KKX
Austin Medical, Inc.
General Hospital · 125d
Cleared Sep 25, 2006
COOLTOUCH, MODEL CTEV
K061618 · GEX
New Star Lasers, Inc.
General & Plastic Surgery · 108d
Cleared Sep 25, 2006
ETHICON ENDO SURGERY ENDOSCOPIC SUTURING SYSTEM
K061770 · OCW
Ethicon Endo-Surgery, Inc.
Gastroenterology & Urology · 94d
Cleared Sep 25, 2006
ARTHROTEK MAXFIRE MENISCAL REPAIR DEVICE
K061776 · JDR
Arthrotek, Inc.
Orthopedic · 94d
Cleared Sep 25, 2006
DOUBLEPLAY SUTURE ANCHOR
K061949 · HWC
Biocomposites, Ltd.
Orthopedic · 77d
Cleared Sep 25, 2006
SCD GARMENT, MODEL VP530
K061967 · JOW
Compression Therapy Concepts, Inc.
Cardiovascular · 75d
Cleared Sep 25, 2006
HARMONIC WAVE COAGULATING SHEARS WITH SCISSOR HANDEL AND HAND CONTROL, MODEL...
K062000 · LFL
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 70d
Cleared Sep 25, 2006
COOL TOUCH, MODELS CT3S, CTEV, NS160, CTEV, LC160
K062210 · GEX
New Star Lasers, Inc.
General & Plastic Surgery · 55d
Cleared Sep 25, 2006
TRUEPULSE DISPOSABLE INVASIVE BLOOD PRESSURE MONITORING KIT
K062342 · DRS
Sentra Medical Devices, LLC
Cardiovascular · 45d
Cleared Sep 25, 2006
CD HORIZON SPINAL SYSTEM
K062606 · MNI
Medtronic Sofamor Danek
Orthopedic · 20d
Cleared Sep 25, 2006
QUICKIE RHAPSODY, MWD SERIES II POWER WHEELCHAIR
K062701 · ITI
Sunrise Medical, Inc.
Physical Medicine · 14d
Cleared Sep 22, 2006
STRYKER INJECTABLE CEMENT
K060763 · GXP
Stryker
Neurology · 185d
Cleared Sep 22, 2006
KENSEY NASH BONE VOID FILLER
K060917 · MQV
Kensey Nash Corporation
Orthopedic · 171d
Cleared Sep 22, 2006
ACTICAL
K060919 · GWK
Respironics, Inc.
Neurology · 171d
Cleared Sep 22, 2006
VISTA P VERTEBRAL BODY REPLACEMENT SYSTEM
K061155 · MQP
Zimmer Trabecular
Orthopedic · 149d
Cleared Sep 22, 2006
ALLOGRAN-R
K061311 · MQV
Biocomposites, Ltd.
Orthopedic · 135d
Cleared Sep 22, 2006
SELFCHECK GLUCO
K061528 · CGA
Card Guard Scientific Survival , Ltd.
Chemistry · 112d
Cleared Sep 22, 2006
HEMOSIL HOMOCYSTEINE AND CONTROLS
K061598 · LPS
Instrumentation Laboratory CO
Chemistry · 106d
Cleared Sep 22, 2006
DIMENSION VISTA C3 AND C4 FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR,...
K061852 · CZW
Dade Behring, Inc.
Immunology · 84d
Cleared Sep 22, 2006
MODIFICATION TO MYALLERGY TEST
K061979 · JKA
Immunetech Corporation
Immunology · 71d
Cleared Sep 22, 2006
EVIS EXERA II 180 SYSTEM
K062049 · NWB
Olympus Medical Systems Corporation
Gastroenterology & Urology · 64d
Cleared Sep 22, 2006
PAJUNKS DISPOSABLE INSERTS FOR HANDLE INSTRUMENTS AND HF ELECTRODES
K062072 · GEI
PAJUNK GmbH Medizintechnologie
General & Plastic Surgery · 63d
Cleared Sep 22, 2006
HLR MODEL 601 HEART LUNG RESUSCITATOR AND HEARTSAVER 100
K062119 · DRM
Medical Products Mfg., LLC
Cardiovascular · 59d
Cleared Sep 22, 2006
MIMVIEWER
K062163 · LLZ
Mimvista Corp.
Radiology · 56d