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

Filters: Cleared only ×
175,820 results
45313–45336 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 27, 2012
NNC GOLD ABUTMENT FOR BRIDGES
K113606 · NHA
Straumann USA
Dental · 52d
Cleared Jan 27, 2012
NCB STRAIGHT NARROW SHAFT PLATES
K113718 · HRS
Zimmer GmbH
Orthopedic · 39d
Cleared Jan 27, 2012
CATHETER CONNECTIONS' DUALCAP SOLO
K113842 · QBP
Catheter Connections, Inc.
General Hospital · 30d
Cleared Jan 26, 2012
CYNOSURE CELLULAZE LASER
K102541 · OYW
Cynosure, Inc.
General & Plastic Surgery · 510d
Cleared Jan 26, 2012
AQUILION PRIME
K110066 · JAK
Toshiba America Medical Systems, In.C
Radiology · 381d
Cleared Jan 26, 2012
CLICKFINE AUTOPROTECT PEN NEEDLE
K110312 · FMI
Ypsomed AG
General Hospital · 358d
Cleared Jan 26, 2012
NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE, TESTED FOR USE WITH...
K111134 · LZA
Siem Aempemed Corp., Ltd.
General Hospital · 279d
Cleared Jan 26, 2012
GAP ENDO-EXO MEDULLARY SYSTEM
K111232 · HSB
Pega Medical, Inc.
Orthopedic · 269d
Cleared Jan 26, 2012
HOFFMANN 3 MODULAR EXTERNAL FIXATION SYSTEM
K111786 · KTT
Stryker Corp.
Orthopedic · 216d
Cleared Jan 26, 2012
LOGIC LAPAROSCOPIC INSTRUMENT SYSTEM
K111986 · GEI
Surgical Innovations Plc
General & Plastic Surgery · 197d
Cleared Jan 26, 2012
ANAXBLEND MODEL 20XXX (SEVERAL), ANAXGUM MODEL 25XXX (U), MOCK-UP DIRECT...
K112044 · EBF
Anaxdent GmbH
Dental · 192d
Cleared Jan 26, 2012
SIMPLELINE II ABUTMENT SYSTEM
K112045 · NHA
Dentium Co., Ltd.
Dental · 192d
Cleared Jan 26, 2012
BICARB MIXING AND DISTRIBUTION SYSTEM
K112427 · FIN
Isopure, Corp.
Gastroenterology & Urology · 156d
Cleared Jan 26, 2012
GIZA(R) VERTEBRAL BODY REPLACEMENT
K112429 · MQP
Eden Spine, LLC
Orthopedic · 156d
Cleared Jan 26, 2012
FORE-SIGHT ABSOLUTE TISSUE OXIMETER
K112820 · MUD
Cas Medical Systems, Inc.
Cardiovascular · 120d
Cleared Jan 26, 2012
CALG-STR EXERCISE ECG ANALYSIS ALGORITHM
K112959 · DPS
Philips Health Care
Cardiovascular · 114d
Cleared Jan 26, 2012
SPINEOLOGY PEEK BULLET LUMBAR INTERBODY FUSION DEVICE
K113030 · MAX
Spineology, Inc.
Orthopedic · 106d
Cleared Jan 26, 2012
LOGICSCAN 64 LOGICSCAN 128
K113184 · IYN
Telemed
Radiology · 90d
Cleared Jan 26, 2012
GAL-1A BLOOD GLUCOSE MONITORING SYSTEM
K113208 · CGA
Apex BioTechnology Corp.
Chemistry · 86d
Cleared Jan 26, 2012
PIONEER RELEASE LAMINOPLASTY PLATING SYSTEM
K113218 · NQW
Pioneer Surgical Technology, Inc.
Orthopedic · 86d
Cleared Jan 26, 2012
RISE SPACER
K113447 · MAX
Globus Medical, Inc.
Orthopedic · 66d
Cleared Jan 26, 2012
PILOT TUBE REPAIR KIT
K113644 · BSK
Instrumentation Industries, Inc.
Anesthesiology · 45d
Cleared Jan 26, 2012
INFX-8000V WITH
K120073 · OWB
Toshibamedical Systems Corporation
Radiology · 16d
Cleared Jan 26, 2012
AM-6000 ANESTHESIA MACHINE
K120075 · BSZ
Advanced Instrumentations, Inc.
Anesthesiology · 16d