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

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176,076 results
64897–64920 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 09, 2005
MULTIWAVE XR
K051876 · GEX
Pacific Quantum Instruments, Inc.
General & Plastic Surgery · 60d
Cleared Sep 09, 2005
ALL PURPOSE CUFF, MODEL 222APC
K051904 · DXQ
Suntech Medical, Inc.
Cardiovascular · 58d
Cleared Sep 09, 2005
I-FLOW ELASTOMERIC PUMP (ON-Q, PAINBUSTER, C-BLOCK, HOMEPUMP, EASYPUMP)
K052117 · MEB
I-Flow Corp.
General Hospital · 36d
Cleared Sep 09, 2005
TRU-SWAB STOCOCK
K052330 · FMG
Medegen Medical Manufacturing Services
General Hospital · 14d
Cleared Sep 09, 2005
Z-CHAIR
K052353 · ITI
Pride Mobility Products Corp.
Physical Medicine · 11d
Cleared Sep 09, 2005
BIS EEG MONITOR, MODEL A-3000
K052362 · OLW
Aspect Medical Systems, Inc.
Neurology · 11d
Cleared Sep 09, 2005
ALILIFE STAND UP POWERED WHEELCHAIR, HC-300
K052375 · IPL
Alilife Technological Co., Ltd.
Physical Medicine · 10d
Cleared Sep 09, 2005
I-PORT
K052389 · FOZ
Patton Medical Devices
General Hospital · 9d
Cleared Sep 08, 2005
ZIVF-AIRE
K041952 · MQG
Zander Medical Supplies, Inc.
Obstetrics & Gynecology · 415d
Cleared Sep 08, 2005
HEARTSTART MRX WITH Q-CPR OPTION, MODELS M3535A OR M3536A
K051134 · MKJ
Philips Medical Systems
Cardiovascular · 128d
Cleared Sep 08, 2005
LEVITRONIX CENTRIMAG BACK-UP CONSOLE
K051209 · KFM
Levitronix, LLC
Cardiovascular · 120d
Cleared Sep 08, 2005
THE NEEDLE CATCHER
K051281 · HTD
E.D.Medical , Ltd.
General & Plastic Surgery · 114d
Cleared Sep 08, 2005
ELECSYS N-MID OSTEOCALCIN, ELECSYS OSTEOCALCIN CALSET, ELECSYS OSTEOCALCIN...
K051297 · NEO
Roche Diagnostics Corp.
Chemistry · 113d
Cleared Sep 08, 2005
LEGEND ALL-POLY CUP
K051407 · JDI
Ortho Development Corp.
Orthopedic · 100d
Cleared Sep 08, 2005
STRATUS CS ACUTE CARE MB ISOENZYME OF CREATINE KINASE (CKMB) TEST PAK
K051650 · JHX
Dade Behring, Inc.
Chemistry · 79d
Cleared Sep 08, 2005
SPINEASSIST DEVICE WITH ADDITIONAL ACCESSORIES
K051676 · HAW
Mazor Surgical Technologies , Ltd.
Neurology · 77d
Cleared Sep 08, 2005
DR. OPPEL ST-501
K051956 · GEI
Sometech Incorporated
General & Plastic Surgery · 51d
Cleared Sep 08, 2005
SYNTHES 4.5 MM LCP STRAIGHT RECONSTRUCTION PLATES
K051986 · HRS
Synthes (Usa)
Orthopedic · 48d
Cleared Sep 08, 2005
VOLAR PLATE SYSTEM
K052150 · HRS
Dvo Extremity Solutions, LLC
Orthopedic · 31d
Cleared Sep 08, 2005
OMRON AUTOMATIC BLOOD PRESSURE MONITOR, MODEL HEM-741CREL
K052153 · DXN
Omron Healthcare, Inc.
Cardiovascular · 30d
Cleared Sep 08, 2005
OMRON AUTOMATIC BLOOD PRESSURE MONITOR, MODEL HEM-711AC
K052154 · DXN
Omron Healthcare, Inc.
Cardiovascular · 30d
Cleared Sep 08, 2005
WELCH ALLYN CARDIOPERFECT WORKSTATION VERSION 1.5.0 SOFTWARE
K052158 · BZG
Welch Allyn, Inc.
Anesthesiology · 30d
Cleared Sep 08, 2005
DATEX-OHMEDA S/5 TONOMETRY MODULE, E TONO AND ACCESSORIES
K052167 · CCK
Ge Healthcare
Anesthesiology · 30d
Cleared Sep 08, 2005
MODIFICATION TO XIA SPINAL SYSTEM
K052181 · KWP
Stryker Spine
Orthopedic · 29d