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

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ORTRON 90* HIP PROSTHESIS

FDA 510(k)
FDA Class 2 ·Orthopedic

ACUMED

FDA UDI
Acumed LLC·10806378103209·Small Frag Base Set Platter 3, VA

SURE-SNAP

FDA UDI
Gc Orthodontics America Inc.·E53580262700001·SURE-SNAP 1. MOLAR UPR LFT SZ 27

MINXRAY, MODEL CMDR-1S AND CMDR-1S-MIL

FDA 510(k)
FDA Class 2 ·Radiology

ATRIUM MEDICAL CORPORATION CLEARWAY PTFE BALLOON CATHETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

INFUSE BONE GRAFT

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·May 9, 2014

840 VENTILATOR

FDA Adverse Event
Malfunction ·COVIDIEN, FORMERLY NELLCOR·Product code CBK·October 19, 2012

PRIMEADVANCED

FDA Adverse Event
Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·May 28, 2015

ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B

FDA Enforcement
Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022

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