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

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175,820 results
43129–43152 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 03, 2012
GEMINUS FOSSA SPECIFIC PLATE SYSTEM
K122737 · HRS
Skeletal Dynamics, LLC
Orthopedic · 27d
Cleared Oct 03, 2012
ELTECH CHINICAL SYSTEM AMYLASE SL ELITECH CLINICAL SYSTEMS ELICAL2 ELTECH...
K122858 · JFJ
Elitechgroup
Chemistry · 15d
Cleared Oct 03, 2012
CD HORIZON SPINAL SYSTEM
K122862 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 16d
Cleared Oct 02, 2012
AOS SOLID LOCKING LAG SCREW, AOS TELESCOPING LAG SCREW
K120148 · HSB
Advanced Orthopaedic Solutions, Inc.
Orthopedic · 258d
Cleared Oct 02, 2012
SHIGA TOXIN QUIK CHEK
K121364 · GMZ
Techlab Inc., Corporate Research Center
Microbiology · 148d
Cleared Oct 02, 2012
SHIGA TOXIN CHEK
K121411 · GMZ
Techlab Inc., Corporate Research Center
Microbiology · 144d
Cleared Oct 02, 2012
SPEEDICATH COMPACT SET (12 FR)
K121457 · GBM
Coloplast Corp.
Gastroenterology & Urology · 139d
Cleared Oct 02, 2012
ESON NASAL MASK
K121597 · BZD
Fisher & Paykel Healthcare Limited
Anesthesiology · 124d
Cleared Oct 02, 2012
ULTHERA SYSTEM
K121700 · OHV
Ulthera, Inc.
General & Plastic Surgery · 117d
Cleared Oct 02, 2012
6-8MM X 30 MM INTRAFIX PEEK TAPERED SCREW 7-9MM X 30MM INTRAFIX PEEK TAPERED...
K122123 · MBI
Depuy Mitek, Inc., A Johnson and...
Orthopedic · 76d
Cleared Oct 02, 2012
AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING
K122133 · MWI
Airstrip Technologies, LP
Cardiovascular · 76d
Cleared Oct 02, 2012
GIRAFFE AND PANDA WARMERS
K122267 · FMT
Ohmeda Medical, A Division of...
General Hospital · 64d
Cleared Oct 02, 2012
EPIX IRRIGATION PUMP, EPIX SUCTION IRRIGATION TUBING SET
K122619 · BTA
Applied Medical
General & Plastic Surgery · 35d
Cleared Oct 02, 2012
PENUMBRA PUMP MAX (110VAC), PENUMBRA PUMP MAX (230VAC), PENUMBAR PUMP MAX...
K122756 · JCX
Penumbra, Inc.
General & Plastic Surgery · 25d
Cleared Oct 01, 2012
INVIA MOTION NEGATIVE PRESSURE WOUND THERAPY SYSTEM
K113678 · OMP
Medela AG
General & Plastic Surgery · 292d
Cleared Oct 01, 2012
SERF ABLATION SYSTEM SERF ABLATION NEEDLE
K120116 · GEI
Thermedical
General & Plastic Surgery · 262d
Cleared Oct 01, 2012
SMARTLUX
K120460 · GEX
Medmix Co., Ltd.
General & Plastic Surgery · 229d
Cleared Oct 01, 2012
TANGORS MULTIFUNCTIONAL POSTERIOR SYSTEM
K120891 · NKB
Ulrich GmbH & Co. KG
Orthopedic · 192d
Cleared Oct 01, 2012
SOLSTICE CROSS CONNECTOR
K120998 · KWP
Life Spine
Orthopedic · 182d
Cleared Oct 01, 2012
ORTHOLOC 3DI ANKLE FUSION PLATING SYSTEM
K121425 · HRS
Wrightmedicaltechnologyinc
Orthopedic · 140d
Cleared Oct 01, 2012
SPEEDICATH COMPACT SET (12/18 FR)
K121458 · GBM
Coloplast A/S
Gastroenterology & Urology · 138d
Cleared Oct 01, 2012
AFT PROXIMAL HUMERUS FRACTURE PLATE
K121672 · HRS
Shoulder Options, Inc.
Orthopedic · 117d
Cleared Oct 01, 2012
NOVATION LPI PRIME FEMORAL STEM
K121684 · LPH
Exactech, Inc.
Orthopedic · 116d
Cleared Oct 01, 2012
REVERE STABILIZATION SYSTEM
K122226 · NKB
Globus Medical, Inc.
Orthopedic · 67d