12 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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EXACTECH EQUINOXE XL KEELED GLENOID, PEGGED GLENOID, EXACTECH EQUINOXE CAGE, GLENOID CONTD.
FDA 510(k)
FDA Class 2
·Orthopedic
MDLR CNLTD TRIDRV DRVR
FDA Adverse Event
Malfunction
·EXACTECH, INC.·Product code LXH·August 29, 2023
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450561508·
ACE BIO WIN TIBIAL NAILING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
UF BRACHYTHERAPY STAND
FDA 510(k)
FDA Class 2
·Radiology
SOL-MILLENNIUM
FDA Adverse Event
Malfunction
·SOL-MILLENNIUM MEDICAL INC·Product code FMF·May 16, 2025
ITRAK 3500
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code LLZ·April 26, 2013
INTERMATE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code FRN·September 16, 2014
ZIMMER TRABECULAR METAL HUMERAL STEM
FDA Adverse Event
Malfunction
·ZIMMER, INC.·Product code KWT·April 12, 2011
PATIENT INFORMATION CENTER IX
FDA Adverse Event
Injury
·PHILIPS MEDICAL SYSTEMS·Product code MHX·August 21, 2023
XP-XP Tibial Tray - Interlok 79 mm Item # 195758
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·September 18, 2019
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