10 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODELS IR1DA1-2, IR1DE1-2
FDA 510(k)
FDA Class 2
·General Hospital
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091033817·Baltic Denture System BDLoad BDLoad ↓ Sw6 PLSEu...
GLO-SPEC
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
PATTERN RESIN
FDA 510(k)
FDA Class 2
·Dental
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·February 10, 2025
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 3, 2013
UNKNOWN DEPUY ASR HIP
FDA Adverse Event
Injury
·DEPUY INT'L., LTD.·Product code KWA·March 17, 2011
GDC 10-ULTRASOFT STRETCH RESISTANT COIL
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORP.·Product code HCG·April 24, 2008
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