21 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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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