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
65233–65256 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 05, 2005
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - DAPTOMYCIN 0.125 - 32 UG/ML
K051689 · LON
Becton, Dickinson & CO
Microbiology · 43d
Cleared Aug 05, 2005
7F SHERPA NX GUIDE CATHETER
K051846 · DQY
Medtronic Vascular
Cardiovascular · 29d
Cleared Aug 05, 2005
CLEVER CHEK TD-4225, MODEL TD-4225
K051854 · NBW
Taidoc Technology Corporation
Chemistry · 28d
Cleared Aug 05, 2005
DATEX-OHMEDA S/5 EEG MODULE, E-EEG AND DATEX-OHMEDA S/5 EEG HEADBOX, N-EEG...
K051883 · OLT
Ge Healthcare
Neurology · 24d
Cleared Aug 05, 2005
CHARLOTTE SMALL MTP FUSION PLATE
K051884 · HRS
Wrightmedicaltechnologyinc
Orthopedic · 24d
Cleared Aug 05, 2005
POLAR CATH PERIPHERAL DILATATION SYSTEM
K051916 · LIT
Cryo Vascular Systems, Inc.
Cardiovascular · 21d
Cleared Aug 05, 2005
4.5 MM LS FACET COMPRESSION DEVICE WITH POLYMER WASHER, MODEL LSPW-45-3040
K051949 · MRW
Triage Medical, Inc.
Orthopedic · 21d
Cleared Aug 05, 2005
MODEL 3000 AXYALOOP BIO-ABSORBABLE BONE ANCHOR
K051983 · MAI
Axya Medical, Inc.
Orthopedic · 14d
Cleared Aug 05, 2005
GII QUICKANCHOR PLUS WITH ORTHOCORD SUTURE
K051989 · JDR
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 14d
Cleared Aug 05, 2005
MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM
K052037 · KTT
Howmedica Osteonics Corp.
Orthopedic · 8d
Cleared Aug 05, 2005
OMNI SPHINCTEROTOME
K052051 · KNS
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 7d
Cleared Aug 05, 2005
SPLASH! IMPRESSION MATERIAL DEVICE
K052090 · ELW
Discus Dental, Inc.
Dental · 3d
Cleared Aug 04, 2005
OSTEOGUIDE ANORGANIC BONE MINERAL PRODUCTS
K043034 · NPM
Collagen Matrix, Inc.
Dental · 274d
Cleared Aug 04, 2005
MERITS HEALTH PRODUCTS OXYGEN CONCENTRATOR
K050430 · CAW
Merits Health Products Co., Ltd.
Anesthesiology · 167d
Cleared Aug 04, 2005
IMMUNALYSIS COCAINE ELISA FOR HAIR
K050465 · DIO
Immunalysis Corporation
Chemistry · 154d
Cleared Aug 04, 2005
INION ANCHRON BIODEGRADABLE ANCHOR SYSTEM, MODEL ANC-6000
K051362 · MAI
Inion OY
Orthopedic · 71d
Cleared Aug 04, 2005
INNER-LOCK INTRODUCER SHEATH
K051468 · DYB
Rex Medical
Cardiovascular · 62d
Cleared Aug 04, 2005
COBALT BONE CEMENT
K051496 · LOD
Biomet, Inc.
Orthopedic · 59d
Cleared Aug 04, 2005
AMBU NEUROLINE GROUND
K051529 · GXY
Ambu, Inc.
Neurology · 56d
Cleared Aug 04, 2005
VIEWSEND MEDICAL SYSTEM
K051586 · LLZ
Kenei Co., Ltd.
Radiology · 50d
Cleared Aug 04, 2005
PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH
K051601 · DYB
Terumo Medical Corp.
Cardiovascular · 49d
Cleared Aug 04, 2005
QUILL SYNTHETIC ABSORBABLE BARBED SUTURE
K051609 · NEW
Quill Medical, Inc.
General & Plastic Surgery · 48d
Cleared Aug 04, 2005
DENTRONIX DDS 7000 RAPID DRY HEAT STERILIZER STERILIZATION SYSTEM
K051660 · KMH
Coltene/Whaledent, Inc.
General Hospital · 43d
Cleared Aug 04, 2005
JMS SYSLOC MINI A.V. FISTULA NEEDLE SET AND APHERESIS NEEDLE SET
K051814 · FIE
Jms North America Corp.
Gastroenterology & Urology · 30d