14 results · 24ms · Sources: EU EUDAMED, US FDA

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VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS

FDA 510(k)
FDA Class 2 ·Cardiovascular

Surestream

FDA UDI
ORIDION MEDICAL 1987 LTD.·20884521552163·SMART SURELINE PLUS O2 ADULT

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450286708·

SOFIA VERGARA

FDA UDI
FGX INTERNATIONAL INC.·00193033440568·

BIOSORBFX AND BIOSORBPDX MESH

FDA 510(k)
FDA Class 2 ·Dental

ZYNERGY Z4 TRANSVENOUS BIPOLAR PACING CATHETER, MODEL 04-X-02-3-10-3

FDA 510(k)
FDA Class 2 ·Cardiovascular

CONTACT DETACH

FDA Adverse Event
Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·November 17, 2025

CONTACT DETACH

FDA Adverse Event
Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·November 18, 2025

LIFEVEST WCD 4000 SYSTEM

FDA Adverse Event
Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·February 22, 2013

ASR UNI FEMORAL IMPL SIZE 45

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·February 24, 2011

HEARTMATE XVE LVAS

FDA Adverse Event
Injury ·THORATEC CORPORATION·Product code DSQ·March 12, 2008

STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 3, SHORT NECK

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JDI·September 9, 2024

ARROW OnControl Bone Marrow Biopsy System Tray, Sterile, Rx only, Manufactured for: Teleflex Medical, The Arrow OnControl Bone Marrow Aspiration System is intended for bone marrow aspiration of the iliac crest of adult and pediatric patients. The Arrow¿ OnControl Bone Marrow Biopsy System is intended for bone marrow core biopsy of the anterior or posterior iliac crest of adult patients

FDA Enforcement
Class II ·Terminated·Teleflex Medical·December 7, 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