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
67033–67056 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 10, 2005
ROCHE AMPLICHIP CYP450 TEST
K043576 · NTI
Roche Molecular Systems, Inc.
Chemistry · 14d
Cleared Jan 07, 2005
5.0 CANNULATED DRILL PIN, 6.0 CANNULATED DRILL-PIN
K033856 · KTT
Peter Stevens, MD
Orthopedic · 393d
Cleared Jan 07, 2005
SOLAR 2 ANATOMIC SHOULDER
K040432 · HSD
Stryker Orthopaedics
Orthopedic · 323d
Cleared Jan 07, 2005
B-R-A-H-M-S PCT LIA
K040887 · NTM
Brahms Aktiengesellschaft
Microbiology · 277d
Cleared Jan 07, 2005
X-TREME ARTHROSCOPIC PUMP AND SHAVER SYSTEM
K041824 · HRX
Future Medical Systems, SA
Orthopedic · 185d
Cleared Jan 07, 2005
PLASIATEK ACTUATOR
K041917 · BTR
Plasiatek, LLC
Anesthesiology · 175d
Cleared Jan 07, 2005
PROXIS SYSTEM, MODEL EPS 101
K042117 · DQY
Velocimed, Inc.
Cardiovascular · 155d
Cleared Jan 07, 2005
ACETAMINOPHEN-SL ASSAY
K042330 · LDP
Diagnostic Chemicals , Ltd.
Toxicology · 133d
Cleared Jan 07, 2005
CHEMVIEW-10
K042641 · JIL
Cenogenics Corp.
Chemistry · 102d
Cleared Jan 07, 2005
GLAXY 3.2 SPINAL SYSTEM
K043020 · KWP
Medtronic Sofamor Danek
Orthopedic · 65d
Cleared Jan 07, 2005
EMIT II PLUS ECSTASY ASSAY
K043028 · DKZ
Dade Behring, Inc.
Toxicology · 65d
Cleared Jan 07, 2005
SYNTHES (USA) CHRONOS
K043045 · MQV
Synthes (Usa)
Orthopedic · 64d
Cleared Jan 07, 2005
DYNATRON IBOX IONTOPHORESIS DEVICE
K043047 · EGJ
Dynatronics Corp.
Physical Medicine · 64d
Cleared Jan 07, 2005
TRUGRAFT BGS SYRINGE, MODEL 600-041
K043172 · FMF
Osteobiologics, Inc.
General Hospital · 52d
Cleared Jan 07, 2005
RUSCH EASY TUBE
K043205 · BTR
Teleflex Medical
Anesthesiology · 49d
Cleared Jan 07, 2005
LIQUID ASSAYED MULTIQUAL CONTROL
K043208 · JJY
Bio-Rad
Chemistry · 49d
Cleared Jan 07, 2005
BF+
K043347 · MQV
Ldr Spine USA
Orthopedic · 32d
Cleared Jan 07, 2005
4100 PATIENT OXIMETER MODULE
K043359 · DQA
Nonin Medical, Inc.
Anesthesiology · 32d
Cleared Jan 07, 2005
POWDERED VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED)
K043477 · LYZ
Shijiazhuang Winful Plastic Co., Ltd.
General Hospital · 22d
Cleared Jan 07, 2005
MEDELA DOMINANT 35 C/I SECRETION AND SURGICAL ASPIRATOR
K043544 · BTA
Medela AG
General & Plastic Surgery · 15d
Cleared Jan 07, 2005
MODIFICATION TO VERTE-STACK SPINAL SYSTEM
K043566 · MQP
Medtronic Sofamor Danek
Orthopedic · 11d
Cleared Jan 06, 2005
VANGUARD REPROCESSED PULSE OXIMETER SENSORS
K042316 · NLF
Vanguard Medical Concepts, Inc.
Anesthesiology · 133d
Cleared Jan 06, 2005
VITROS CHEMISTRY PRODUCTS GENT, TOBRA & VANC REAGENTS
K042479 · LCD
Ortho-Clinical Diagnostics, Inc.
Toxicology · 115d
Cleared Jan 06, 2005
INVACARE PRO, COMPACT AND PORTABLE DESKTOP
K042483 · CAF
Invacare Corporation
Anesthesiology · 115d