17 results · 28ms · Sources: EU EUDAMED, US FDA

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Cardiac Trigger Monitor

FDA 510(k)
FDA Class 2 ·Cardiovascular

Fluid Retention Ring

FDA UDI
KATENA PRODUCTS, INC.·00841668112854·VIDAURRI FLUID RETENTION WELL 8.7MM

Corneal Trephine

FDA UDI
KATENA PRODUCTS, INC.·00841668112779·BARRON VACUUM PUNCH 8.0MM

Conventional Lead Apron .5mm Xtra Xtra Large 26 X 42

FDA UDI
Flow X Ray Corporation·00843696123918·Conventional Lead Apron .5mm XXL 26 X 42, Shimm...

Corneal Trephine

FDA UDI
KATENA PRODUCTS, INC.·00841668112939·CORNEAL TREPHINE BLADE8.0MM

SPECTRANETICS 0.035 SUPPORT CATHETER, MODEL 518-028

FDA 510(k)
FDA Class 2 ·Cardiovascular

PARADIGM SILHOUETTE, MODELS MMT-377, 378, 379, 380

FDA 510(k)
FDA Class 2 ·General Hospital

SCULPTRA

FDA Adverse Event
Injury ·Q-MED AB·Product code LMH·December 16, 2025

COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

FDA Adverse Event
Malfunction ·STAAR SURGICAL CO.·Product code HQL·October 16, 2008

ACRYSOF

FDA Adverse Event
Injury ·ALCON LABORATORIES IRELAND LTD.·Product code HQL·August 5, 2011

SYNCHROMED II

FDA Adverse Event
Malfunction ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 2, 2013

BLOOD PUMP PU VALVES 15 ML, IN/OUT Ø9 MM

FDA Adverse Event
Malfunction ·BERLIN HEART GMBH·Product code DSQ·January 4, 2022

BD DISCARDIT II - 2-PIECE SYRINGE

FDA Adverse Event
Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·May 17, 2023

THERMOCOOL SMARTTOUCH SF

FDA Adverse Event
Malfunction ·BIOSENSE WEBSTER, INC.·Product code LPB·August 8, 2024

PHOS2 PHOSPHATE (INORGANIC) VER.2

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code CEO·October 14, 2021

ECHELON

FDA Adverse Event
Injury ·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRA·March 2, 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