12 results
·
22ms
·
Sources: EU EUDAMED, US FDA
EMIT-STM ETHYL ALCOHOL URINE CALIBRATOR
FDA 510(k)
FDA Class 2
·Clinical Toxicology
LOCATOR
FDA UDI
Zest Anchors, LLC·00840481100987·LOCATOR Bar Processing Replacement Male, (Yello...
36M - MSHA Miners
FDA UDI
Certified Safety Manufacturing, Inc.·00766588026206·36M - MSHA Miners
SURE-SNAP
FDA UDI
Gc Orthodontics America Inc.·E53580262000001·SURE-SNAP 1. MOLAR UPR LFT SZ 20
ONCE-A-DAY VERTOS TEST PACK
FDA 510(k)
FDA Class 2
·General Hospital
SURESMILE SYSTEM
FDA 510(k)
FDA Class 1
·Dental
SMR HUMERAL HEAD Ø48 MM
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A.·Product code KWT·May 8, 2024
CONTOUR NEXT EZ
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE LLC·Product code NBW·May 9, 2014
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY NELLCOR·Product code CBK·October 19, 2012
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·September 18, 2007
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