22 results · 21ms · Sources: EU EUDAMED, US FDA

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FLAMENCO SPINAL FIXATION SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04049772814541·GENUMEDI SAND SIZE III

Endo Carry-On Procedure Kit

FDA UDI
MEDIVATORS INC.·00677964073908·Endo Carry-On Procedure Kit

CORAIL2 NON COL HO SIZE 10

FDA Adverse Event
Injury ·DEPUY FRANCE SAS - 3003895575·Product code KWA·September 12, 2019

SCITON IMAGE HAIR REMOVAL LASER

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

SMART GLOVE STERILE NITRILE EXAM GLOVE

FDA 510(k)
FDA Class 1 ·General Hospital

WALLSTENT RP ENDOPROSTHESIS

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code MAF·April 19, 2023

IVT DISPOSABLE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - CALI·Product code KPE·May 9, 2013

FLOGARD

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 19, 2014

4.5MM OLECRANON THREADED COMPRESSION ROD

FDA Adverse Event
Injury ·ACUMED LLC·Product code HSB·May 25, 2011

WALLSTENT? RP ENDOPROSTHESIS

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FGE·July 21, 2025

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

EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209

FDA Enforcement
Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021

Model Number L211 PROPONENT DR SL MRI Pacemaker

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

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

Hemodialysis Delivery System, Software Version 2.x.

FDA Enforcement
Class II ·Ongoing·Baxter Healthcare Corporation·November 17, 2021