13 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MODIFICATION TO VERTEBRON PSS PEDICLE SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Sklar®
FDA UDI
SKLAR CORPORATION·10649111117411·F.O. MAC SET W/HDL SZ1-4
NOBELACTIVE INTERNAL NP 3.5X11.5MM
FDA Adverse Event
Injury
·NOBEL BIOCARE AB·Product code DZE·August 13, 2020
NOBELACTIVE INTERNAL RP 4.3X10MM
FDA Adverse Event
Injury
·NOBEL BIOCARE USA INC·Product code DZE·September 8, 2020
NOBELACTIVE INTERNAL NP 3.5X11.5MM
FDA Adverse Event
Injury
·NOBEL BIOCARE AB·Product code DZE·August 13, 2020
EVERGREEN AND MULTIPLE PRIVATE LABELS NON-STERILE POWDERED LATEX PATIENT EXAMINATION GLOVES, WITH PROTEIN LABELING (200
FDA 510(k)
FDA Class 1
·General Hospital
TI-MAX PROTRUSIO CAGE
FDA 510(k)
FDA Class 2
·Orthopedic
XIA 3 TITANIUM BLOCKER
FDA Adverse Event
Malfunction
·STRYKER SPINE-SWITZERLAND·Product code MNI·January 21, 2016
SM204 M-SERIES W/BIG WHEEL
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FPO·April 22, 2013
LARGE NEEDLE DRIVER INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC.·Product code GCJ·July 7, 2008
UNKNOWN DEPUY ASR ACETABULAR CUP
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·April 13, 2011
CT EXPRES
FDA Adverse Event
Injury
·BRACCO INJENEERING S.A.·Product code IZQ·September 27, 2023
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