12 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
SAXON RIBBED CONDOMS
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Brigade
FDA UDI
Nuvasive, Inc.·00887517453549·Brigade HL Trial, 12x34x24mm 15°
icotec Lumbar Cage PLIF 0° / 25 mm x 09 mm
FDA UDI
icotec AG·07640164848235·icotec Lumbar Cage PLIF 0° / 25 mm x 09 mm
icotec Lumbar Cage PLIF 0° / 25 mm x 09 mm
FDA UDI
icotec AG·07640140438214·icotec Lumbar Cage PLIF 0° / 25 mm x 09 mm
EDWARDS LIFESCIENCES VENOUS RETURN CANNULAE
FDA 510(k)
FDA Class 2
·Cardiovascular
NOVALIS (SHAPED BEAM SURGERY SYSTEM)
FDA 510(k)
FDA Class 2
·Radiology
TRILOGY 100
FDA Adverse Event
Malfunction
·RESPIRONICS INC.·Product code CBK·May 7, 2014
RIATA ACTIVE FIXATION
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·January 8, 2013
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·ANIMAS CORP.·Product code LZG·November 12, 2010
Beckman Coulter UniCel DxI 600, Part Numbers: A71460, A30260; Photometric Chemistry Analyzer
FDA Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·November 12, 2025
UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260
FDA Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·August 13, 2025
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