9 results
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27ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ZIMMER PATIENT-SPECIFIC ABUTMENT, INTERNAL HEX, TITANIUM
FDA 510(k)
FDA Class 2
·Dental
MODIFICATION TO BIOZ.COM HEMODYNAMIC MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
ORTHOCEPH OC100 D
FDA 510(k)
FDA Class 2
·Dental
TENDRIL DX
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code NVN·January 14, 2014
ENDURANT II
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·April 22, 2013
TOTAL ASR FEM IMP SIZE 47
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·April 13, 2011
RD SET NEO CS-3
FDA Adverse Event
Malfunction
·MASIMO - 52 DISCOVERY·Product code DQA·January 29, 2021
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012
Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024