23 results · 22ms · Sources: EU EUDAMED, US FDA

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RELINE-IT MODEL RELINE-IT

FDA 510(k)
FDA Class 2 ·Dental

Endeavour™ TruColor™

FDA UDI
METREX RESEARCH, LLC·00615375013533·Endeavour™ TruColor™ headlight system - North A...

Ambu

FDA UDI
Bosma Enterprises·10818634025132·Ambu aScope 4 RhinoLaryngo Slim 5/Box

RANDOX THEOPHYLLINE

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

ORTHOVITA PEEK SPACER

FDA 510(k)
FDA Class 2 ·Orthopedic

BD LUER SLIP¿ TUBERCULIN SYRINGE

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FMF·February 8, 2018

CATHETER AND CANNULA

FDA Adverse Event
Malfunction ·TERUMO CARDIOVASCULAR SYSTEM CORP·Product code DWF·May 3, 2013

TERUMO ADVANCED PERFUSION SYSTEM 1

FDA Adverse Event
Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTQ·May 10, 2011

TALENT ABDOMINAL STENT GRAFT SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC CARDIOVASCULAR·Product code MIH·August 7, 2008

PERSONA TRABECULAR METAL 2 PEG TIBIAL COMPONENT

FDA Adverse Event
Injury ·ZIMMER, INC.·Product code MBH·August 29, 2016

SYRINGE 5ML LL TIP BULK CONVENIENCE PAK

FDA Adverse Event
Malfunction ·BECTON DICKINSON·Product code FMF·January 27, 2021

Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410. Model Number: WA91307C. The ESG-410 Electrosurgical Generator is an electrosurgical generator which utilizes monopolar and bipolar high frequency current and supports ultrasonic instruments during open surgery, laparoscopic surgery, including single-site surgery, and endoscopic surgery.

FDA Enforcement
Class II ·Ongoing·Olympus Corporation of the Americas·August 27, 2025

HA FlexTrak-Patient transport functionality to transport the patient from the preparation area to the MR system, Product Number: 989710006411

FDA Enforcement
Class II ·Ongoing·Philips North America Llc·June 12, 2024

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

Model Number L211 PROPONENT DR SL MRI Pacemaker

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

Accolade pacemaker, Models: a) L300 b) L301 c) L310 d) L311 e) L321 f) L331

FDA Enforcement
Class II ·Ongoing·Boston Scientific Corporation·July 14, 2021

VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

INGENIO DR EL (pacemakers), Model Numbers: a) J174 b) J177 c) K174 (added 7/15/2021) d) K184 (added 7/15/2021) e) K187 (added 7/15/2021)

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

INVIVE CRT-P, Model Numbers: a) V172 b) V173 c) V182 d) V183 e) W172 f) W173

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

ADVANTIO DR EL (pacemaker), Model Numbers: a) J064 b) J067 c) K064 (added 7/15/2021) d) K084 (added 7/15/2021) e) K087 (added 7/15/2021)

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021