15 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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C2000 AUTOMATED MANIFOLD KIT
FDA 510(k)
FDA Class 2
·Cardiovascular
JOBST forMen
FDA UDI
BSN MEDICAL, INC.·04042809845716·FOR MEN 20-30 MM HG KNEE HIGH CLOSED TOE LARGE ...
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·June 3, 2020
REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
INTRAORAL LENS OPTION TO SPECTROSHADE
FDA 510(k)
FDA Class 1
·Dental
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·January 6, 2021
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code LXH·March 31, 2017
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·May 7, 2020
ALTRUA
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·April 11, 2013
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·March 15, 2011
DEEP BRAIN STIMULATION LEAD (X2)
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO·Product code MHY·May 23, 2008
CD HORIZON® SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code NKB·December 29, 2024
INFUSE BONE GRAFT/LT-CAGE
FDA Adverse Event
Injury
·MEDTRONIC·Product code NEK·November 12, 2013
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Malfunction
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·February 17, 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