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
61729–61752 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 08, 2006
MODIFICATION TO: ORLUS MINI SCREW
K052968 · DZE
Ortholution Co., Ltd.
Dental · 322d
Cleared Sep 08, 2006
DIALYSIS SERVICES, INC., TYPHOON BICARB MIXING AND DISTRIBUTION SYSTEM
K060333 · FIN
Dialysis Services, Inc.
Gastroenterology & Urology · 211d
Cleared Sep 08, 2006
EUROIMMUN PR3 ELISA KIT. EUROIMMUN MPO ELISA KIT.
K060700 · MOB
Euroimmun Us, LLC
Immunology · 177d
Cleared Sep 08, 2006
QUICKVUE RSV (20 TEST KIT), MODEL 20193
K061008 · MCE
Quidel Corp.
Microbiology · 149d
Cleared Sep 08, 2006
SCREW-VENT IMPLANT SYSTEM, SV
K061410 · DZE
Zimmer Dental, Inc.
Dental · 109d
Cleared Sep 08, 2006
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K061591 · KWP
Medtronic Sofamor Danek, Inc.
Orthopedic · 92d
Cleared Sep 08, 2006
FORMCORE DC, MODEL 28-700100
K061664 · EBF
J. Morita USA, Inc.
Dental · 86d
Cleared Sep 08, 2006
ANTI-SNORING / SLEEP APNEA DEVICE
K061688 · LRK
Tomed Dr. Toussaint GmbH
Dental · 85d
Cleared Sep 08, 2006
ZIMMER ONE-PIECE IMPLANT, 3.7 MM, ANGLED
K061717 · DZE
Zimmer Dental, Inc.
Dental · 81d
Cleared Sep 08, 2006
INFIBRA, MODEL 1200
K061735 · EBI
Global Dental Products, Inc.
Dental · 80d
Cleared Sep 08, 2006
STRYKER SILVERGLIDE BIPOLAR FORCEPS REUSABLE CABLE
K061835 · GEI
Stryker Instruments
General & Plastic Surgery · 71d
Cleared Sep 08, 2006
SYNTHES LCP ANKLE ARTHRODESIS PLATES
K061940 · HRS
Synthes (Usa)
Orthopedic · 60d
Cleared Sep 08, 2006
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - MOXIFLOXACIN (STREP) 0.0625 - 8UG/ML
K062206 · LON
Becton, Dickinson & CO
Microbiology · 38d
Cleared Sep 08, 2006
VPAP MALIBU WITH H2I
K062291 · BZD
Resmed, Ltd.
Anesthesiology · 32d
Cleared Sep 08, 2006
SUPERDIMENSION/BRONCHUS PREMIUM 2
K062315 · JAK
Superdimension, Ltd.
Radiology · 30d
Cleared Sep 08, 2006
TIMESH SELF DRILLING SCREW
K062348 · HWC
Medtronic Neurosurgery
Orthopedic · 28d
Cleared Sep 08, 2006
TRANSEAR BONE CONDUCTION HEARING AID
K062404 · LXB
Ear Technology Corp.
Ear, Nose, Throat · 22d
Cleared Sep 08, 2006
5F SHERPA ACTIVE NX GUIDE CATHETER
K062420 · DQY
Medtronic Vascular
Cardiovascular · 21d
Cleared Sep 08, 2006
MINI POWER CHAIR, MODEL MN 5000
K062483 · ITI
Line Ind.(Shanghai) Co., Ltd.
Physical Medicine · 14d
Cleared Sep 08, 2006
INCORIS AL
K062506 · EIH
Sirona Dental Systems GmbH
Dental · 11d
Cleared Sep 08, 2006
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K062522 · LYZ
Jiangsu Jaysun Glove Co., Ltd.
General Hospital · 11d
Cleared Sep 07, 2006
KLS MARTIN STERNAL TALON
K051165 · HRS
KLS-Martin L.P.
Orthopedic · 490d
Cleared Sep 07, 2006
PROXIS SYSTEM
K052523 · NFA
Velocimed, Inc.
Cardiovascular · 358d
Cleared Sep 07, 2006
TRUMPET VALVE HANDLE WITH 3-METRE TUBING, SINGLE SPIKE, 5MM CANNULA, TRUMPET...
K060182 · GCJ
Australian Surgical Devices
General & Plastic Surgery · 226d