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
45625–45648 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 19, 2011
ADVANCED PERFUSION SYSTEM 1 (APS1) TUBE CLAMP ASSEMBLY, ROLLER PUMP 6 INCH...
K112587 · DWB
Terumo Cardiovascular Systems Corp.
Cardiovascular · 104d
Cleared Dec 19, 2011
LIPIFLOW THERMAL PULSATION SYSTEM
K112704 · ORZ
Tearscience, Inc.
Ophthalmic · 94d
Cleared Dec 19, 2011
MECTA-C
K112862 · ODP
Medacta International
Orthopedic · 80d
Cleared Dec 19, 2011
ZIMMER PLATES AND SCREWS SYSTEM SCREWS ONLY
K112885 · HWC
Zimmer, Inc.
Orthopedic · 80d
Cleared Dec 19, 2011
AXSOS LOCKING PLATE SYSTEM
K112926 · HRS
Stryker Corp.
Orthopedic · 77d
Cleared Dec 19, 2011
ACL TIGHTROPE,ACL TIGHTROPE DUUBLE BUNDLE
K112990 · HTY
Arthrex, Inc.
Orthopedic · 74d
Cleared Dec 19, 2011
LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS)
K113434 · NKB
Lanx, Inc.
Orthopedic · 28d
Cleared Dec 17, 2011
HD-IVUS ULTRASOUND IMAGING SYSTEM
K112997 · IYN
Silicon Vally Medical Instruments, Inc.
Radiology · 71d
Cleared Dec 17, 2011
8MP COLOR LCD MONITOR,RADIFORCE RX840
K113226 · LLZ
Eizo Nanao Corporation
Radiology · 46d
Cleared Dec 17, 2011
BIOGRAPH MCT FAMILY
K113448 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 26d
Cleared Dec 16, 2011
PRO FOCUS 2202, PRO FOCUS 2202 UV MODEL: TYPE 2202
K100919 · IYN
B-K Medical Aps
Radiology · 623d
Cleared Dec 16, 2011
MED GRAVITY SET, IMED PUMP SET
K102712 · KNT
Imed Technology, Inc.
Gastroenterology & Urology · 452d
Cleared Dec 16, 2011
LIQUIBAND FLOW CONTROL
K110184 · MPN
Medlogic Global Limited
General & Plastic Surgery · 329d
Cleared Dec 16, 2011
PROPHECY INBONE PRE-OPERATIVE NAVIGATION ALIGNMENT GUIDES
K110360 · HSN
Wrightmedicaltechnologyinc
Orthopedic · 311d
Cleared Dec 16, 2011
HYPERTENSION MANAGEMENT SOFTWARE CLAIENT SERVER (HMS-CS)
K110603 · DXN
I.E.M. GmbH
Cardiovascular · 288d
Cleared Dec 16, 2011
AMECATH AND AMECATH UNIQATH SOFT SHORT TERM DUAL HEMODIALYSIS CATHETERIZATION...
K110793 · MPB
Ameco Medical Industries
Gastroenterology & Urology · 269d
Cleared Dec 16, 2011
ULTRASONIC SURGICAL UNIT
K110881 · DZI
Dong IL Technology , Ltd.
Dental · 261d
Cleared Dec 16, 2011
SBV2, MULTICHARGER MODEL MC10V2
K111514 · LEL
Sleep Performance D.B.A. Fatigue Science
Neurology · 198d
Cleared Dec 16, 2011
IMMUNOCARD C. DIFFICILE GDH
K112048 · MCB
Meridian Bioscience, Inc.
Microbiology · 151d
Cleared Dec 16, 2011
AMSCO CHIMERON MEDIUM STEAM STERILIZER
K112055 · FLE
STERIS Corporation
General Hospital · 150d
Cleared Dec 16, 2011
DISPOSABLE THERMOMETER COVERS AND SHEATHS
K112289 · FLL
Kang ZE Industrial Co. Limited
General Hospital · 129d
Cleared Dec 16, 2011
LANX CERVICAL SA
K112388 · OVE
Lanx, Inc.
Orthopedic · 120d
Cleared Dec 16, 2011
VERIGENE STAPHYLOCOCCUS BLOOD CULTURE NUCLEIC ACID TEST (BC-S)
K112424 · NQX
Nanosphere, Inc.
Microbiology · 115d
Cleared Dec 16, 2011
NOVABONE DENTAL MORSELS - BIOACTIVE SYNTHETIC BONE GRAFT
K112428 · LYC
Novabone Products, LLC
Dental · 115d