9 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PLEURX PERITONEAL CATHETER SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BIO-MODULAR SHOULDER SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304214057·
AO USB RECEIVER, WI-BOX, WI-BOX PSU KIT, WI-BOX XPRESS CABLE, PW USB RECEIVER
FDA 510(k)
FDA Class 2
·Cardiovascular
MARK 5000 QUADRATURE SHOULDER COIL
FDA 510(k)
FDA Class 2
·Radiology
STAPLE, IMPLANTABLE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·May 15, 2013
PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES
FDA Adverse Event
Malfunction
·INVACARE REHABILITATION EQUIP·Product code BTI·September 24, 2014
ROUND FLUTED BUR, LONG
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS CORK·Product code GFF·May 17, 2011
Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Model Number L131, ESSENTIO DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025