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
56761–56784 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 01, 2008
SYNTHES 6.5MM MIDFOOT FUSION BOLT
K081071 · HWC
Synthes (Usa)
Orthopedic · 16d
Cleared May 01, 2008
3-D IMAGING WORKSTATION
K081093 · LLZ
Eigen, LLC
Radiology · 14d
Cleared May 01, 2008
FUTAR (FUTAR, FUTAR D, FUTAR D FAST, FUTAR D SLOW, FUTAR SCAN BITE...
K081120 · ELW
Kettenbach GmbH & Co. KG
Dental · 10d
Cleared Apr 30, 2008
EMU-GRAPH EMULATOR, MODEL CI 131
K072408 · JOJ
Steritec Products Mfg Co, Inc.
General Hospital · 247d
Cleared Apr 30, 2008
DEMETECH ABSORBABLE SURGICAL SUTURE PLAIN & CHROMIC GUT
K072930 · GAL
Demetech Corp.
General & Plastic Surgery · 197d
Cleared Apr 30, 2008
VANTAGECATH INTRAVASCULAR CATHETER
K073471 · FOZ
Advantage Medical Device
General Hospital · 141d
Cleared Apr 30, 2008
WG-SURGICAL SUTURES WITH NEEDLE
K073614 · NEW
Foosin Medical Supplies, Inc.
General & Plastic Surgery · 126d
Cleared Apr 30, 2008
MAS TOX CONTROL
K080085 · DIF
Thermo Fisher Scientific
Toxicology · 110d
Cleared Apr 30, 2008
VITEK 2 GRAM POSITIVE INDUCIBLE CLINDAMYCIN RESISTANCE
K080201 · LON
bioMerieux, Inc.
Microbiology · 93d
Cleared Apr 30, 2008
P.004 ABUTMENTS, P.004 TEMPORARY COPINGS, P.004 PROTECTIVE CAPS, P.004...
K080239 · NHA
Straumann Manufacturing, Inc.
Dental · 90d
Cleared Apr 30, 2008
SYNTHES CRANIOFACIAL PLATE AND SCREW SYSTEM
K080331 · JEY
Synthes (Usa)
Dental · 84d
Cleared Apr 30, 2008
EndoWave Infusion System
K080392 · QEY
Ekos Corp.
Cardiovascular · 77d
Cleared Apr 30, 2008
OSSEOSPEED NARROW
K080396 · DZE
Astra Tech AB
Dental · 77d
Cleared Apr 30, 2008
REGENAFIL, REGENAFORM, ALRIVA DBM PASTE, SLTIVA DM WITH CORTICAL CANCELLOUS...
K080418 · NUN
Regeneration Technologies, Inc.
Dental · 75d
Cleared Apr 30, 2008
MODIFICATON TO: PYRAMID +4 ANTERIOR LUMBAR PLATE SYSTEM
K080429 · KWQ
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 71d
Cleared Apr 30, 2008
NON STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, BLUE, POLYMER COATING...
K080520 · LZA
Siam Sempermed Corp., Ltd.
General Hospital · 65d
Cleared Apr 30, 2008
CONTURA MULTI-LUMEN BALLOON SOURCE APPLICATOR FOR BRACHYTHERAPY, MODELS...
K080791 · JAQ
Senorx, Inc.
Radiology · 41d
Cleared Apr 30, 2008
EMAX 2 PLUS SYSTEM, MODEL EMAX 2 PLUS MOTOR, EMAX 2 CONSOLE>FIRMWARE...
K080802 · HBE
The Anspach Effort, Inc.
Neurology · 40d
Cleared Apr 30, 2008
ORWELL FLUID COLLECTION AND DISPOSAL SYSTEM
K080845 · JCX
Cardinalhealth
General & Plastic Surgery · 35d
Cleared Apr 30, 2008
MOND RVOT STYLET MODELS 4140, 4141, 4150, 4151
K080924 · DRB
St. Jude Medical, Cardiac Rhythm...
Cardiovascular · 28d
Cleared Apr 30, 2008
XIA SPINAL SYSTEM, STAINLESS STEEL UNI-PLANAR SCREWS
K080928 · NKB
Stryker Spine
Orthopedic · 28d
Cleared Apr 29, 2008
MPS OXIPORT AND MPS OXIPORT PLUS
K072379 · GWM
Innerspace, Inc.
Neurology · 249d
Cleared Apr 29, 2008
ENOLOK-FOR ENDOSCOPED WITH 12.8>DIA.<13.3MM SHAFT DIAMETER, MODEL AEL
K080317 · FDF
Syntheon, LLC
Gastroenterology & Urology · 83d
Cleared Apr 29, 2008
FASTLOCK, MODEL PC175M01, PC175MCE, PC005R01
K080621 · DSA
European Custom Manufacturing BV
Cardiovascular · 55d