20 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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HARDYDISK CINOXACIN, 100 MCG
FDA 510(k)
FDA Class 2
·Microbiology
ODYSSEY®
FDA UDI
Microport Orthopedics Inc.·M684K00143871·
GRADIA®
FDA UDI
Gc America Inc.·D0470014871·GRADIA® ENAMEL INTENSIVE EI1
TruForm
FDA UDI
Rmo, Inc.·00885797099679·MAN MOLAR BDS PEDO ASST 100
GRADIA®
FDA UDI
Gc America Inc.·14548161392785·GRADIA® ENAMEL INTENSIVE EI1
artVeneer life
FDA UDI
Merz Dental GmbH·D7092001487·artVeneer life lower anteriors, UBM, D3
ActivHeal
FDA UDI
ADVANCED MEDICAL SOLUTIONS LIMITED·15032749001484·SILICONE FOAM BORDER 10x10CM
PTA BALLOON CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
MEDTRADE PRODUCTS ALGINATE ISLAND
FDA 510(k)
FDA Unclassified
·Unknown
LINEAR 3-4
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·September 19, 2022
POLYFORM SYNTHETIC MESH
FDA Adverse Event
Injury
·PROXY BIOMEDICAL LTD.·Product code FTL·November 9, 2012
TECNIS IOL
FDA Adverse Event
Malfunction
·AMO PUERTO RICO MFG. INC.·Product code HQL·June 4, 2024
CHARGING SYSTEM
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·March 5, 2013
CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Death
·EDWARDS LIFESCIENCES·Product code DYE·February 25, 2011
CYPHER SIROLIMUS-ELUTING CORONARY STENT
FDA Adverse Event
Injury
·CORDIS DE MEXICO·Product code NIQ·February 19, 2008
Li-Ion battery used in the Oxus Portable Oxygen Concentrator (POC), RS-00400. Also branded as Reliability Plus byDrive. The Portable Oxygen Concentrator is intended to deliver concentrated oxygen for adult patients with chronic pulmonary diseases.
FDA Enforcement
Class II
·Terminated·Oxus America, Inc.·February 13, 2013
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
Xhibit Telemetry Receiver, Model: 96280
FDA Enforcement
Class II
·Ongoing·Spacelabs Healthcare, Inc.·August 17, 2022
Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025
Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly
FDA Enforcement
Class II
·Ongoing·Covidien·August 28, 2024