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
74569–74592 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 31, 2002
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - GENTAMICIN 0.25 - 16 UG/ML
K023273 · LON
Becton, Dickinson & CO
Microbiology · 30d
Cleared Oct 31, 2002
MAS DIABETES CONTROL - LYOPHILIZED ASSAYED DIABETES CONTROL
K023307 · JJX
Medical Analysis Systems, Inc.
Chemistry · 28d
Cleared Oct 31, 2002
MODIFICATION TO ULTIMUM EV HEMOSTASIS INTRODUCER (22F)
K023447 · DYB
St Jude Medical
Cardiovascular · 16d
Cleared Oct 31, 2002
OSSTAPLE, MAXILLOFACIAL
K023486 · JEY
Biomedical Enterprises, Inc.
Orthopedic · 14d
Cleared Oct 31, 2002
OSSTAPLE, CRANIOFACIAL
K023488 · JEY
Biomedical Enterprises, Inc.
Orthopedic · 14d
Cleared Oct 31, 2002
WELCH ALLYN VITALS SOFTWARE DEVELOPERS KIT (SDK)
K023495 · DXN
Welch Allyn, Inc.
Cardiovascular · 13d
Cleared Oct 30, 2002
TRI-PLEX ADAPTER
K010401 · MOD
The Medical Device Group, Inc.
Anesthesiology · 625d
Cleared Oct 30, 2002
LUMENIS ULTRAPULSE ENCORE CARBON DIOXIDE SURGICAL LASERS AND DELIVERY DEVICE...
K022060 · GEX
Lumenis, Inc.
General & Plastic Surgery · 127d
Cleared Oct 30, 2002
\RESENIUS ACCESS FLOW RESERVING CONNECTORS, FRESENIUS STANDALONE ACCCES FLOW...
K022536 · KOC
Fresenius Medical Care
Gastroenterology & Urology · 90d
Cleared Oct 30, 2002
NEWDEAL K WIRE
K022599 · HTY
New Deal, S.A.
Orthopedic · 86d
Cleared Oct 30, 2002
NEW OUTLINE
K023079 · EBG
Anaxdent GmbH
Dental · 44d
Cleared Oct 30, 2002
PHILIPS DIGITAL IMAGING OPTION RELEASE 1
K023440 · LLZ
Philips Medical Systems
Radiology · 15d
Cleared Oct 30, 2002
PHILIPS MULTIDIAGNOST ELEVA
K023441 · IZI
Philips Medical Systems
Radiology · 15d
Cleared Oct 29, 2002
SPIRITUS(TM) RESPIRATORY SYSTEM #SRS 001
K020641 · BZD
Worldwide Medical Technologies, LLC
Anesthesiology · 244d
Cleared Oct 29, 2002
TRAXX ELECTRIC WHEELCHAIR
K022194 · ITI
Crossroads Distribution Company, LLC
Physical Medicine · 116d
Cleared Oct 29, 2002
CENTERPULSE, SPINE-TECH DIVISION CEMENT RESTRICTOR
K022615 · JDK
Centerpulse Spine-Tech, Inc.
Orthopedic · 83d
Cleared Oct 29, 2002
MOISTURESTAY (REVLON)
K022626 · IMC
Raymond Industrial, Ltd.
Physical Medicine · 83d
Cleared Oct 29, 2002
EXPORT ASPIRATION CATHETER
K023303 · NFA
Medtronic Vascular
Cardiovascular · 26d
Cleared Oct 29, 2002
1CC FUTURA SAFETY SYRINGE
K023323 · MEG
Futura Medical Technology
General Hospital · 25d
Cleared Oct 29, 2002
DISETRONIC H-TRONPLUS INSULIN INFUSION PUMP
K023471 · LZG
Disetronic Medical Systems AG
General Hospital · 14d
Cleared Oct 28, 2002
ARTERIA OCCLUSION BALLOON
K021210 · MJN
Arteria Medical Science, Inc.
Cardiovascular · 194d
Cleared Oct 28, 2002
NEOGRAM PKU TANDEM MASS SPECTROMETRY KIT
K021541 · JNB
Perkinelmer Life Sciences
Chemistry · 171d
Cleared Oct 28, 2002
KARATS MULTIPURPOSE SOLUTION
K021635 · LPN
Ciba Vision Corporation
Ophthalmic · 164d
Cleared Oct 28, 2002
ACON MDMA ONE STEP ECSTASY TEST STRIP & ACON MDMA ONE STEP ECSTASY TEST DEVICE
K022589 · LAF
ACON Laboratories, Inc.
Chemistry · 84d