12 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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NAVITRACK SYSTEM TOTAL HIP REPLACEMENT,MODEL 900.200
FDA 510(k)
FDA Class 2
·Neurology
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197151986·Micro surgery scalpel blades
# 64 ...
K012364
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JDI·February 3, 2015
AML HIP PROSTHESIS
FDA 510(k)
FDA Class 2
·Orthopedic
PROTEMP H
FDA 510(k)
FDA Class 2
·Dental
WAVEWRITER ALPHA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·December 2, 2021
OVAL SOLID BUR - MEDIUM
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code GFF·March 27, 2013
PROWLER SELECT MICROCATHETERS
FDA Adverse Event
Malfunction
·CORDIS NEUROVASCULAR, INC.·Product code KRA·March 17, 2011
PRECISION XTRA/OPTIUM
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE UK·Product code NBW·March 27, 2008
BD ULTRA FINE¿ PEN NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·January 31, 2022
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
Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018