13 results
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28ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CONCORDE VBR SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
JOBST forMen
FDA UDI
BSN MEDICAL, INC.·04042809845730·FOR MEN 20-30 MM HG KNEE HIGH CLOSED TOE SMALL-...
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·June 3, 2020
ICE BATON
FDA 510(k)
FDA Unclassified
·Unknown
VINYL EXAMINATION GLOVES, POWDER FREE, VANILLA COLOR
FDA 510(k)
FDA Class 1
·General Hospital
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code LXH·March 31, 2017
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·March 11, 2022
ACTIVA
FDA Adverse Event
Malfunction
·NEURO - VILLALBA·Product code MHY·April 11, 2013
ASR UNI FEMORAL IMPL SIZE 45
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·April 7, 2011
ACRYSOF RESTOR
FDA Adverse Event
Malfunction
·ALCON MANUFACTURING, LTD./HUNTINGTON·Product code MFK·May 23, 2008
CD HORIZON® SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code NKB·December 29, 2024
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
CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024