10 results
·
18ms
·
Sources: EU EUDAMED, US FDA
INTERFLO MEDICAL MODEL OXI/CO FILA. THERMO. CATH.
FDA 510(k)
FDA Class 2
·Cardiovascular
NA
FDA UDI
Zimmer, Inc.·00889024156050·
N/A
FDA UDI
UTAH MEDICAL PRODUCTS, INC.·H6719026270·Arterial Blood Collection Kit w/o Transducer
CT2011 SONICSTIMU PAIN RELIEF DEVICE
FDA 510(k)
FDA Class 2
·Physical Medicine
ATRIUM MEDICAL CORPORATION CLEARWAY PTFE BALLOON CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
CS300
FDA Adverse Event
Malfunction
·DATASCOPE CORP.·Product code DSP·May 9, 2014
ENDOPATH*XCEL
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·November 18, 2010
RIATA ACTIVE FIXATION
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·January 8, 2013
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