18 results · 21ms · Sources: EU EUDAMED, 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