10 results · 18ms · Sources: EU EUDAMED, US FDA

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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