16 results
·
27ms
·
Sources: EU EUDAMED, US FDA
MODIFICATION TO: CIC PRO CLINICAL INFORMATION CENTER CENTRAL STATION
FDA 510(k)
FDA Class 2
·Cardiovascular
WILSON-COOK ULTRASOUND BIOPSY NEEDLE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
KLOCK WATCH STYLE DIGITAL BLOOD PRESSURE MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
QUICK-CORE ULTRASOUND BIOPSY NEEDLE
FDA Adverse Event
Injury
·COOK ENDOSCOPY·Product code FCG·September 4, 2018
STRATUS CS
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW·Product code DAP·November 11, 2015
STRATUS CS
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW·Product code DAP·November 9, 2015
METASUL DUROM, COMPONENT FOR ACETABULUM, UNCEMENTED, 48, 42,CODE H
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·June 19, 2018
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 11, 2013
4.0MM AGGRESSIVE PLUS CUTTER, FORMULA (5BX)
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY PUERTO RICO·Product code HRX·March 16, 2011
ACCOLADE
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS CORK·Product code MEH·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