18 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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NICOLET VERSALAB
FDA 510(k)
FDA Class 2
·Radiology
Zirlux
FDA UDI
HENRY SCHEIN, INC.·H65890105210·Zirlux Titanium Screw compatible with: Nobel Bi...
Custom Procedure Kit
FDA UDI
MEDIVATORS INC.·00677964150685·Endo Carry-on Procedure Kit contains Intercept ...
Kalitec Special
FDA UDI
Kalitec Direct LLC·B073DRK0100210·SNII Awl Tap, 5.50mm
InSePtion MIS Fixation System
FDA UDI
Kalitec Direct LLC·B07314K0100210·Caddie Lid, Implant
Matira
FDA UDI
Kalitec Direct LLC·B07307K0100210·Assembly, Caddie, Plates and Screws, Hinged
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K0100210·Caddie Lid, Rods, 5.5mm
KEYSTONE HIP
FDA 510(k)
FDA Class 2
·Orthopedic
SOFTSENS
FDA 510(k)
FDA Class 2
·Neurology
Z.S.G.M. CUTTER 3:1 RATIO ( CAUTION: SHARP )
FDA Adverse Event
Malfunction
·ZIMMER SURGICAL, INC.·Product code FZW·January 4, 2024
Z.S.G.M. CUTTER 1.5:1 RATIO ( CAUTION: SHARP )
FDA Adverse Event
Malfunction
·ZIMMER SURGICAL, INC.·Product code FZW·January 4, 2024
Z.S.G.M. CUTTER 4:1 RATIO ( CAUTION: SHARP )
FDA Adverse Event
Malfunction
·ZIMMER SURGICAL, INC.·Product code FZW·January 4, 2024
OCTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·March 14, 2013
TMJ MED RT FOSSA COMPONENT
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code LZD·March 8, 2011
HELEX
FDA Adverse Event
W.L. GORE AND ASSOCIATES, IN.·Product code MLV·February 8, 2008
TEMPUS LS - MANUAL
FDA Adverse Event
Death
·SCHILLER AG·Product code LDD·February 4, 2022
Upper roller bracket (part number 1088370) for the Gen2 gantry enclosure for the Radixact Treatment Delivery System.
FDA Enforcement
Class II
·Completed·Accuray Incorporated·September 6, 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