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

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RVT CTO DEVICE

FDA 510(k)
FDA Class 2 ·Cardiovascular

UniTip High Resolution Catheter

FDA UDI
Unisensor AG·07640172973646·

UniTip High Resolution Catheter

FDA UDI
Unisensor AG·07640172973561·

Procure

FDA UDI
Twin Med, LLC·10840330700709·Trach Tie Medium, Foam w/moisture repellent bac...

ACTI-FLEX IV ADMINISTRATION SET

FDA 510(k)
FDA Class 2 ·General Hospital

ALKALINE PHOSPHATASE LIQUID REAGENT

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·April 29, 2025

GALAXY G3 MINI 1MM X 1CM

FDA Adverse Event
Malfunction ·MEDOS INTERNATIONAL SARL·Product code KRD·August 13, 2020

9900

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 1, 2013

MOSS MIAMI SI FINAL TIGHTENER

FDA Adverse Event
Malfunction ·DEPUY SYNTHES SPINE·Product code HXX·September 19, 2014

9800

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 11, 2011

MEDTRONIC TRANSCATHETER VALVE

FDA Adverse Event
Death ·MEDTRONIC MEXICO S. DE R.L. DE CV·Product code NPT·December 19, 2025

MEDTRONIC TRANSCATHETER VALVE

FDA Adverse Event
Injury ·MEDTRONIC MEXICO S. DE R.L. DE CV·Product code NPT·December 19, 2025

TherMax Blood Warmer Unit

FDA Enforcement
Class II ·Terminated·Baxter Healthcare Corporation·November 6, 2019

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

Model Number L231, PROPONENT DR EL MRI Pacemaker

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

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