21 results · 21ms · Sources: EU EUDAMED, US FDA

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MODIFICATION TO: MEDRAD SPECTRIS SOLARIS MR INJECTOR SYSTEM

FDA 510(k)
FDA Class 2 ·Cardiovascular

RIWOtrack Flexsensor

FDA UDI
Fiagon GmbH·04260759930096·Navigation probe, component of RIWOtrack Naviga...

NIDO Pedicle Screw System

FDA UDI
Kalitec Direct LLC·B07315K0120500·Screwdriver, Assembled Screws SNI1

InSePtion MIS Fixation System

FDA UDI
Kalitec Direct LLC·B07314K0120500·Inserter, All-In-One

PedFuse®

FDA UDI
SPINEFRONTIER, INC.·00190361012108·PedFuse Respond, SLD, 8.0mm x 50mm

FOSTER GRANT

FDA UDI
FGX INTERNATIONAL INC.·00193033444924·

SEEDNET, MODEL FP6T5, FP5T5, FP5T3

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

CYPRESS SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

0009613348-2024-012950

FDA Adverse Event
Injury ·INSTITUT STRAUMANN AG·Product code DZE·September 30, 2024

S-ROM HEAD FEMORAL COCR 28+3

FDA Adverse Event
Malfunction ·DEPUY ORTHOPAEDICS INC US·Product code JDG·August 8, 2008

PINN MAR LIP LNR 28IDX52OD

FDA Adverse Event
Malfunction ·DEPUY ORTHOPAEDICS INC US·Product code LPH·August 8, 2008

MODULAR HEAD COMPONENT 28 MM HEAD DIAMETER STANDARD NECK TYPE 1 TAPER

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code JDI·November 3, 2016

RINGLOC BI-POLAR 28X49MM

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code KWY·August 21, 2017

LIFEVEST WCD 4000 SYSTEM

FDA Adverse Event
Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·February 26, 2013

PRIMARY SUPER SECUR-FIT PLUS SIZE 7-11MM DISTAL S

FDA Adverse Event
Injury ·STRYKER ORTHOPAEDICS CORK·Product code MEH·March 2, 2011

MODEL 3000 30ML MED FLOW PUMP

FDA Adverse Event
Injury ·CODMAN & SHURTLEFF, INC.·Product code LKK·March 13, 2008

ULTRAPRO MESH UNKNOWN PRODUCT

FDA Adverse Event
Injury ·ETHICON INC.·Product code FTL·May 8, 2018

PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT

FDA Adverse Event
Injury ·ETHICON INC.·Product code FTL·May 8, 2018

G7 DUAL MOBILITY LINER 44MM F

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code LPH·November 14, 2018

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