16 results
·
21ms
·
Sources: EU EUDAMED, US FDA
DENTURE DYNAMIC'S DENTURE MAGIC
FDA 510(k)
FDA Class 1
·Dental
GASTRIC SUCTION AND DRAINAGE CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MASIMO SET RAD 8 PULSE OXIMETER AND ACCESSORIES, MODEL RAD 8
FDA 510(k)
FDA Class 2
·Cardiovascular
RAD-8
FDA Adverse Event
Malfunction
·MASIMO CORPORATION·Product code DQA·July 15, 2015
CADD LEGACY PUMP
FDA Adverse Event
Malfunction
·ST PAUL·Product code FRN·April 11, 2022
CADD LEGACY PLUS PUMP
FDA Adverse Event
Malfunction
·ST PAUL·Product code FRN·September 8, 2022
CADD LEGACY PLUS PUMP
FDA Adverse Event
Malfunction
·ST PAUL·Product code FRN·September 23, 2022
CADD LEGACY PLUS PUMP
FDA Adverse Event
Malfunction
·ST PAUL·Product code FRN·September 22, 2022
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 9, 2013
TX1 TISSUE REMOVAL SYSTEM - MICROTIP
FDA Adverse Event
Malfunction
·TENEX HEALTH·Product code LFL·February 24, 2014
SETROX S 45
FDA Adverse Event
Malfunction
·BIOTRONIK SE & CO. KG·Product code NVZ·November 12, 2010
CADD LEGACY PLUS PUMP
FDA Adverse Event
Malfunction
·ST PAUL·Product code FRN·September 22, 2022
CADD LEGACY PLUS PUMP
FDA Adverse Event
Malfunction
·ST PAUL·Product code FRN·September 8, 2022
CADD LEGACY PLUS PUMPS
FDA Adverse Event
Malfunction
·ST PAUL·Product code FRN·October 29, 2022
CADD LEGACY PLUS PUMPS
FDA Adverse Event
Malfunction
·ST PAUL·Product code FRN·October 24, 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