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
67753–67776 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 20, 2004
OSSATURA DENTAL
K042706 · LYC
Isotis Orthobiologics, Inc.
Dental · 20d
Cleared Oct 20, 2004
ERA 3000 PACING SYSTEM ANALYZER
K042708 · DTE
Biotronik, Inc.
Cardiovascular · 20d
Cleared Oct 20, 2004
OPTIMA MX
K042759 · EIA
Bien-Air SA Switzerland
Dental · 15d
Cleared Oct 20, 2004
MODIFICATION TO ACUSON CV70 CARDIOVASCULAR SYSTEM
K042770 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 15d
Cleared Oct 19, 2004
COMPLETE BLINK-N-CLEAN LENS DROPS
K040839 · MRC
Advanced Medical Optics, Inc.
Ophthalmic · 202d
Cleared Oct 19, 2004
FIRST RESPONSE ONE-STEP DIGITAL PREGNANCY TEST
K040866 · LCX
Armkel, LLC
Chemistry · 200d
Cleared Oct 19, 2004
AURORA DS
K041969 · GEX
Syneron Medical, Ltd.
General & Plastic Surgery · 89d
Cleared Oct 19, 2004
OPUS SPEEDSTITCH SUTURE DEVICE
K042031 · GAT
Opus Medical, Inc.
General & Plastic Surgery · 83d
Cleared Oct 19, 2004
KOLIBRI IMAGE GUIDED SURGERY SYSTEM
K042391 · HAW
Brainlab AG
Neurology · 47d
Cleared Oct 19, 2004
SITE-RITE NEEDLE GUIDE KITS AND PROBE COVER KIT
K042445 · ITX
Bard Access Systems, Inc.
Radiology · 40d
Cleared Oct 19, 2004
PS MEDICAL STRATA II VALVE
K042465 · JXG
Medtronic Neurosurgery
Neurology · 36d
Cleared Oct 19, 2004
HAND STC, MODEL 60MM
K042492 · GDW
Niti Medical Technologies , Ltd.
General & Plastic Surgery · 35d
Cleared Oct 19, 2004
VITROS CHEMISTRY PRODUCTS C3 AND CR REAGENT, CALIBRATOR KIT 20, PROTEIN...
K042494 · CZW
Ortho-Clinical Diagnostics
Immunology · 35d
Cleared Oct 19, 2004
GDC-10 360 DEGREE COIL SR
K042539 · HCG
Boston Scientific Corp
Neurology · 29d
Cleared Oct 19, 2004
RETIC-CHEX FOR CELL-DYN
K042587 · JPK
Streck Laboratories, Inc.
Hematology · 27d
Cleared Oct 19, 2004
DYNACT
K042646 · IZI
Siemens Medical Systems, Inc.
Radiology · 21d
Cleared Oct 19, 2004
COLON CAR 1.2
K042674 · NWE
Medicsight
Radiology · 20d
Cleared Oct 19, 2004
ISC-1000 PENTAX CONFOCAL LASER SYSTEM
K042740 · GCJ
Pentax Medical Company
General & Plastic Surgery · 15d
Cleared Oct 19, 2004
EC-3870CILK, CONFOCAL VIDEO COLONOSCOPE
K042741 · GCJ
Pentax Medical Company
General & Plastic Surgery · 15d
Cleared Oct 19, 2004
IPACS CARDIO
K042781 · LLZ
Realtimeimage, Inc.
Radiology · 13d
Cleared Oct 18, 2004
ALPHA METASUL 28MM AND 32MM ACETABULAR INSERTS, STANDARD AND HOODED
K033943 · KWA
Centerpulse Orthopedics, Inc.
Orthopedic · 304d
Cleared Oct 18, 2004
JEJE TEETHER
K034017 · MEF
Vibe 2000
Dental · 299d
Cleared Oct 18, 2004
MAXAIR SURGICAL HELMET SYSTEM
K040485 · FYA
Bio-Medical Devices, Inc.
General Hospital · 236d
Cleared Oct 18, 2004
DRG SOFTRELEASE
K041018 · HHT
Doctor'S Research Group, Inc.
Obstetrics & Gynecology · 181d