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
60385–60408 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 09, 2007
LORENZ ORTHODONTIC ANCHORAGE SYSTEM
K063386 · OAT
Walter Lorenz Surgical, Inc.
Dental · 93d
Cleared Feb 09, 2007
NOVAMED MRI CONDITIONAL LARYNGOSCOPE SET
K063477 · CCW
Novamed, LLC
Anesthesiology · 85d
Cleared Feb 09, 2007
PALOMAR LUX2940 HANDPIECE
K063571 · GEX
Palomar Medical Technologies, Inc.
General & Plastic Surgery · 72d
Cleared Feb 09, 2007
CLEARFIL MAJESTY POSTERIOR
K063595 · EBF
Kuraray America, Inc.
Dental · 67d
Cleared Feb 09, 2007
INTRALASE FUSION LASER
K063682 · GEX
Intra Lase Corp.
General & Plastic Surgery · 60d
Cleared Feb 09, 2007
FORCE FIBER POLYETHYLENE NONABSORBABLE SUTURE
K063778 · GAT
Teleflex Medical
General & Plastic Surgery · 50d
Cleared Feb 09, 2007
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFAZOLIN (GN) 0.5-32UG/ML
K063811 · LON
Becton, Dickinson & CO
Microbiology · 49d
Cleared Feb 09, 2007
POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K070075 · LYZ
Jiangsu Cureguard Glove Co., Ltd.
General Hospital · 32d
Cleared Feb 09, 2007
TRILOGY RADIOTHERAPY DELIVERY SYSTEM AND TRILOGY TX DELIVERY SYSTEM
K070094 · IYE
Varian Medical Systems, Inc.
Radiology · 30d
Cleared Feb 09, 2007
AEGIS
K070244 · LLZ
Sentinelle Medical, Inc.
Radiology · 15d
Cleared Feb 08, 2007
DBX-H HEMOSTATIC DEMINERALIZED BONE MATRIX PUTTY
K061131 · MBP
Orthocon, Inc.
Orthopedic · 290d
Cleared Feb 08, 2007
EMBRYOASSIST
K061309 · MQL
Medicult A/S
Obstetrics & Gynecology · 274d
Cleared Feb 08, 2007
CLAVIS
K062478 · BXN
Medtronic A/S
Anesthesiology · 168d
Cleared Feb 08, 2007
FORSURE DISPOSABLE SYRINGE WITH NEEDLE, MODEL 1CC, 3C, 5CC, 10CC, 20CC, 50CC
K062753 · FMF
Surgimed, Inc.
General Hospital · 147d
Cleared Feb 08, 2007
INSTANTCHECK RTD-ECG MONITOR, MODEL RMH4.0
K062894 · DPS
Dailycare Biomedical, Inc.
Cardiovascular · 134d
Cleared Feb 08, 2007
HEMOCATH II
K062901 · MSD
Med-Conduit, Inc.
Gastroenterology & Urology · 134d
Cleared Feb 08, 2007
MICROLUX TRANSILLUMINATOR
K062961 · NTK
Addent, Inc.
Dental · 132d
Cleared Feb 08, 2007
POWDER NITRILE EXAMINATION GLOVE (WHITE AND BLUE COLOR)
K063522 · LZA
Hl Rubber Industries Sdn Bhd
General Hospital · 78d
Cleared Feb 08, 2007
MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH CHLORAMPHENICOL...
K063564 · LON
Dade Behring, Inc.
Microbiology · 72d
Cleared Feb 08, 2007
EUSOL-C
K063617 · LYX
Al.Chi.Mi.A
Ophthalmic · 65d
Cleared Feb 08, 2007
FINECUBE DENTAL CT
K063622 · OAS
The Yoshida Dental Mfg. Co., Ltd.
Radiology · 65d
Cleared Feb 08, 2007
KAVO EVEREST C-TEMP
K063624 · EBG
Kavo America
Dental · 64d
Cleared Feb 08, 2007
DURAFLEX
K063626 · EBI
Cosmetic Dental Materials, Inc.
Dental · 64d
Cleared Feb 08, 2007
OLYMPUS XEU-M60A ENDOSCOPIC ULTRASOUND CENTER
K063683 · IYN
Olympus Medical Systems Corporation
Radiology · 58d