9 results
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17ms
·
Sources: EU EUDAMED, US FDA
ANAIROBE-TEK
FDA 510(k)
FDA Class 1
·Microbiology
SURE-SNAP
FDA UDI
Gc Orthodontics America Inc.·E53580262600001·SURE-SNAP 1. MOLAR UPR LFT SZ 26
VEGA MEDICAL SUCTION EQUIPMENT, MODEL SU-01/SU-DC01
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PAM 3000
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
COVIDIEN, FORMERLY NELLCOR·Product code CBK·October 19, 2012
RADIOLUCENT DRIVE MARK II
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HWE·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