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

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MODIFICATION TO AEQUALIS SHOULDER FRACTURE SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

Kwart

FDA UDI
COOK INCORPORATED·00827002149120·Kwart Retro-Inject Ureteral Stent Set

SCANLAN® Titanium Forceps

FDA UDI
SCANLAN INTERNATIONAL INC·00846159003567·Dennis Micro Forceps, RH, 1 mm DD ring tips, 10...

LINK Endo-Model EVO Knee System

FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575274758·Replacement set, CoCrMo, UHMWPE, Ti6Al4V, for ...

HARDY DISK CLARITHROMYCIN, 15MCG

FDA 510(k)
FDA Class 2 ·Microbiology

MEDTRONIC SOLAN FIBEROPTIC CORNEAL LIGHT PROBE

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

UCSS SCREW SET

FDA Adverse Event
Malfunction ·WARSAW ORTHOPEDIC INC.·Product code MRW·June 4, 2009

UCSS SCREW SET

FDA Adverse Event
Malfunction ·WARSAW ORTHOPEDIC INC.·Product code HWC·June 4, 2009

UCSS

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code KWP·February 2, 2016

LIFEVEST WCD 4000 SYSTEM

FDA Adverse Event
Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·February 12, 2013

OMNISPAN MENISCAL FASTERNER, 0 DEGREE NEEDLE

FDA Adverse Event
Injury ·DEPUY MITEK·Product code MBI·February 23, 2011

EAVP WING ELECTRODE - DEVICE #1

FDA Adverse Event
Malfunction ·RICHARD WOLF MEDICAL INSTRUMENTS·Product code FAS·February 20, 2008

UCSS SCREW SET

FDA Adverse Event
Injury ·WARSAW ORTHOPEDIC, INC.·Product code KWP·January 3, 2011

ALLOFT-S ALLOCLASSIC SHL 52/II

FDA Adverse Event
Malfunction ·ZIMMER GMBH·Product code JDI·March 12, 2019

UCSS SCREW SET

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code KWP·April 23, 2020

ALLOFIT-S ALLOCLASSIC, SHELL WITH POLAR SCREW PLUG, UNCEMENTED, 52/II

FDA Adverse Event
Injury ·ZIMMER GMBH·Product code LZO·September 27, 2018

GUIDE, SURGICAL, INSTRUMENT

FDA Adverse Event
Death ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code FZX·September 25, 2019

Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy. Used to provide treatment for neonatal Hyperbilirubinemia. 006224 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad 006254 neoBLUE blanket LED Light Box 006895 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad 007299 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad EUR 007300 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad EUR 007296 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad UK 007298 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad UK 007301 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad AUS 007296 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad AUS

FDA Enforcement
Class II ·Terminated·Natus Medical Incorporated·December 21, 2016

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

1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

FDA Enforcement
Class II ·Ongoing·B-K Medical A/S·November 12, 2025