10 results
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18ms
·
Sources: EU EUDAMED, US FDA
NEONATAL PHOTOTHERAPY UNIT
FDA 510(k)
FDA Class 2
·General Hospital
Synergy
FDA UDI
Rmo, Inc.·00885797101099·SYN BENCH 185HK 345 5-5 20EA
SURE-SNAP
FDA UDI
Gc Orthodontics America Inc.·E53580270200001·SURE-SNAP 2. MOLAR UPR LFT SZ 02
EXACTECH EQUINOXE REVERSE SHOULDER SYSTEM+15MM HUMERAL ADAPTER TRAY
FDA 510(k)
FDA Class 2
·Orthopedic
NEUROTOLOGY DRAPE, MODEL TBD
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
INFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code FRN·May 9, 2014
LIGASURE ADVANCE
FDA Adverse Event
Malfunction
·COVIDIEN KENDALL·Product code GEI·September 12, 2012
SOFTHEAT
FDA Adverse Event
Other
·KAZ, INC.·Product code IRT·August 6, 2010
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