16 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DIMENSION VISTA MYO REAGENT CARTRIDGE AND CALIBRATOR
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496053576·MICROMASSAGE ARMBANDS CCL1, SIZE M, NERO, GRADU...
PERICSCOPE, MODEL # PERISC1
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Q-TEL RMS (REHABILITATION MANAGEMENT SYSTEM), MODEL 000503
FDA 510(k)
FDA Class 2
·Cardiovascular
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 4, 2020
METASUL DUROM, COMPONENT FOR ACETABULUM, UNCEMENTED, 48, 42,CODE H
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·June 19, 2018
PLUM 4-PORT 15 FLTR 2CLV PE LINE 216CM
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·June 27, 2013
VITALITY 2
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 11, 2013
COGNIS
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·April 13, 2011
PALINDROME EMERALD 28/45KIT VT
FDA Adverse Event
Other
·TYCO HEALTHCARE/KENDALL·Product code MPB·May 28, 2008
METASUL DUROM, COMPONENT FOR ACETABULUM, UNCEMENTED, 54, 48, CODE N
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·March 28, 2019
METASUL DUROM, COMPONENT FOR ACETABULUM, UNCEMENTED, 50, 44, CODE J
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·February 20, 2018
METASUL DUROM, COMPONENT FOR ACETABULUM, UNCEMENTED, 50, 44, CODE J
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·February 20, 2018
METASUL DUROM, COMPONENT FOR ACETABULUM, UNCEMENTED, 46/ 40, CODE F
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·June 13, 2018
METASUL DUROM, COMPONENT FOR ACETABULUM, UNCEMENTED, 62/56, CODE V
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·January 31, 2018
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