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