19 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PINNACLE ACETABULAR SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526189799·LEVAMED ACTIVE ANKLE SUP BLACK R IV
Optiglaze™
FDA UDI
Gc America Inc.·D0470015341·Optiglaze™ Brush Flat #1, 10 pieces per box
Optiglaze™
FDA UDI
Gc America Inc.·14548161391924·Optiglaze™ Brush Flat #1, 10 pieces per box
artVeneer life
FDA UDI
Merz Dental GmbH·D7092001534·artVeneer life upper anteriors, BS, BL1
Scanlan® VASCU-STATT® II single-use bulldog clamp w/firmer clamping press
FDA UDI
SCANLAN INTERNATIONAL INC·00846159000115·Scanlan® VASCU-STATT® II single-use bulldog cla...
Regenalase
FDA UDI
IPG Medical Corporation·00810071230530·Laser System
X-Series Size 1 Posterior YELLOW Bite Block 3-pack
FDA UDI
CLIKTECH LLC·00856200001534·X-Series Size 1 Posterior YELLOW Bite Block 3-pack
3M™ Unitek™
FDA UDI
3m do Brasil Ltda.·00652221002334·Unitek(TM) Twin Torque Curved Bracket L5 -22T/0...
COBAS INTEGRA REAGENT CASSETTE FOR RHEUMATOID FACTOR II
FDA 510(k)
FDA Class 2
·Immunology
MODEL APS ALTERNANS PROCESSING SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
LONGY-N IMPLANT
FDA Adverse Event
Injury
·NORIS MEDICAL LTD·Product code DZE·January 26, 2026
EONC
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·March 5, 2013
IVENT 201
FDA Adverse Event
Malfunction
·VERSAMED MEDICAL SYSTEMS, LTD.·Product code CBK·January 26, 2011
STARCLOSE VASCULAR CLOSURE SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR , VASCULAR SOLUTIONS-REDWOOD CITY·Product code MGB·February 21, 2008
Sunrise Brand Zippie Voyage, Chair with Casters, Early Intervention Device (Stroller), Model: EIZ14; Product is manufactured and distributed by Sunrise Medical (US) LLC., Fresno, CA. Used by a person to move from one place to another while sitting.
FDA Enforcement
Class II
·Terminated·Sunrise Medical (US) LLC·December 11, 2013
Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
FDA Enforcement
Class I
·Ongoing·Covidien·November 8, 2023
1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 23, 2013