11 results
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26ms
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Sources: EU EUDAMED, US FDA
PROXIS SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
JOBST forMen
FDA UDI
BSN MEDICAL, INC.·04042809848588·FOR MEN 15-20 MM HG KNEE HIGH CLOSED TOE EXTRA ...
ADVANTAGE DRIVE SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS
FDA 510(k)
FDA Class 2
·Cardiovascular
TI PANGEA LOCKING CAP
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code NKB·June 5, 2012
E SERIES DEFIBRILLATOR
FDA Adverse Event
Death
·ZOLL MEDICAL CORPORATION·Product code MKJ·March 29, 2013
INTERSTIM
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code EZW·April 11, 2011
COBAS INTEGRA 800
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·May 22, 2008
TI PANGEA LOCKING CAP
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code NKB·June 5, 2012
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 CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-35; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024