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
41593–41616 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 05, 2013
DIMENSION VISTA PROGESTERONE CALIBRATOR (PROG CAL)
K130698 · JIT
Siemens Healthcare Diagnostics
Chemistry · 22d
Cleared Apr 05, 2013
LIGASURE 5MM BLUNT TIP LAPAROSCOPIC SEALER/DIVIDER
K130744 · GEI
Covidien
General & Plastic Surgery · 17d
Cleared Apr 05, 2013
ACCUMESH DEPLOYMENT SYSTEM
K130782 · ORQ
Covidien, LLC
General & Plastic Surgery · 15d
Cleared Apr 04, 2013
IMMULITE 2000 ANTI-CCP IGG ASSAY
K121576 · NHX
Siemens Healthcare Diagnostics, Inc.
Immunology · 309d
Cleared Apr 04, 2013
LIAISON FT4 LIAISON CONTROL THYROID 1 LIAISON CONTROL THYROID 2 LIAISON...
K121951 · CEC
DiaSorin, Inc.
Chemistry · 275d
Cleared Apr 04, 2013
LIFE-CARE VAGINAL PROBE LIFE-CARE ANAL PROBE
K122194 · KPI
Everyway Medical Instruments Co.,Ltd
Gastroenterology & Urology · 254d
Cleared Apr 04, 2013
NOVA MAX MINI BLOOD GLUCOSE AND B-KETONE MONITOR
K122688 · LFR
Nova Biomedical Corporation
Chemistry · 212d
Cleared Apr 04, 2013
HDRPLUS, ADD IN PROSTATE MODULE FOR HDRPLUS
K123263 · MUJ
Eckert & Ziegler Bebig GmbH
Radiology · 168d
Cleared Apr 04, 2013
KCI NPWT GAUZE DRESSING
K123507 · OMP
Kci USA, Inc.
General & Plastic Surgery · 142d
Cleared Apr 04, 2013
HYSTEROSCOPY PUMP HM6
K123732 · HIG
W.O.M. World of Medicine AG
Obstetrics & Gynecology · 120d
Cleared Apr 04, 2013
AGILITY
K123808 · IYE
Elekta , Ltd.
Radiology · 114d
Cleared Apr 04, 2013
PHANTOM FIBER BIOFIBER SUTURE
K130422 · NWJ
Tornier, Inc.
General & Plastic Surgery · 43d
Cleared Apr 04, 2013
ELITECH CLINICAL SYSTEMS ELICAL 2
K130765 · JIX
Elitechgroup
Chemistry · 15d
Cleared Apr 03, 2013
PORTABLE THERAPEUTIX SQUID ACTIVE COLD COMPRESSION DEVICE AND COLD PACK
K123829 · IRP
Portable Therapeutix, LLC
Physical Medicine · 112d
Cleared Apr 03, 2013
STRYKER IVAS BALLOON CATHETER
K123942 · NDN
Stryker Corporation
Orthopedic · 104d
Cleared Apr 03, 2013
K100 NEUTRAL DISPLACEMENT NEEDLE FREE CONNECTOR
K130023 · FPA
Np Medical, Inc.
General Hospital · 90d
Cleared Apr 03, 2013
ACCULIF XL CAGE
K130194 · MAX
Coalign Innovations, Inc.
Orthopedic · 65d
Cleared Apr 03, 2013
PROGENT LARGE DIAMETER CONTACT LENS CASE FOR RIGID GAS PERMEABLE LENS
K130285 · LRX
The Lagado Corp.
Ophthalmic · 57d
Cleared Apr 03, 2013
THE RICHARD WOLF ENDOCAM LOGIC HD CAMERA SYSTEM 5525
K130423 · FET
Richard Wolf Medical Instruments Corp.
Gastroenterology & Urology · 42d
Cleared Apr 03, 2013
SPEQRT ULTRASOUND SYSTEM
K130659 · IYN
Signostics Pty, Ltd.
Radiology · 22d
Cleared Apr 02, 2013
INTUITION
K121916 · LLZ
Terarecon,Inc.
Radiology · 274d
Cleared Apr 02, 2013
SYNGO.CT NEURO PERFUSION
K123541 · JAK
Siemens Medical Systems, Inc.
Radiology · 134d
Cleared Apr 02, 2013
BOSSONG HOSIERY MEDICAL COMPRESSION STOCKINGS 8-15 MMHG, BOSSONG HOSIERY...
K123820 · DWL
Bossong Hosiery Mills, Inc.
General Hospital · 111d
Cleared Apr 02, 2013
INMODE SR IPL DEVICE
K123860 · ONF
Inmode MD , Ltd.
General & Plastic Surgery · 109d