14 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Clavicle and Scapula System
FDA 510(k)
FDA Class 2
·Orthopedic
Q IFA ANA Hep-2 18-Well Test System
FDA UDI
ZEUS SCIENTIFIC, INC.·00845533001687·The ZEUS ANA HEp-2 Test System is a prestandard...
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780455516·Integra® Jarit® Cobb Style Bone Curette, Hollow...
Oticon
FDA UDI
Sbo Hearing A/S·05714464053063·OTICON ZIRCON 1 MINIRITE R C090
LCP
FDA UDI
Synthes GmbH·10886982164988·4.5MM LCP® T-PLATE 8 HOLES 147MM
ACCESS DHEA-S REAGENT ASSAY
FDA 510(k)
FDA Class 1
·Clinical Chemistry
MEDOS HILITE INFANT OXYGENATOR
FDA 510(k)
FDA Class 2
·Cardiovascular
DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL·Product code NVN·August 12, 2023
INTERSTIM II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code EZW·March 5, 2013
INTERSTIM II
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·August 6, 2015
530G INSULIN PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·November 10, 2014
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 9, 2011
ALIGN RADIAL HEAD SYSTEM
FDA Adverse Event
Other
·SKELETAL DYNAMICS LLC·Product code KWI·July 16, 2013
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