14 results
·
28ms
·
Sources: EU EUDAMED, US FDA
BEBIG ISOSEED I-125
FDA 510(k)
FDA Class 2
·Radiology
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091033781·Baltic Denture System BDLoad BDLoad ↓ Mw7 PLSEu...
COOLTOUCH VARIA-II ND:YAG LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
RIDIDFIX 2.7MM BTB CROSS PIN KIT
FDA 510(k)
FDA Class 2
·Orthopedic
MEDTRONIC HALL PROSTHETIC HEART VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code LWQ·March 30, 2022
BD VACUTAINER SAFETY-LOK BLOOD COLLECTION SET
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code JKA·June 25, 2021
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 3, 2013
X-SMART
FDA Adverse Event
Malfunction
·DENTSPLY MAILLEFER·Product code LQY·March 23, 2011
GIA 60-3.8 SINGLE USE LOADING UNIT
FDA Adverse Event
Injury
·PONCE - USS·Product code GDW·April 25, 2008
GLIDESHEATH
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DYB·November 1, 2022
GLIDESHEATH
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DYB·December 16, 2022
GLIDESHEATH
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DYB·July 30, 2021
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
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024