15 results
·
29ms
·
Sources: EU EUDAMED, US FDA
ACS ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST
FDA 510(k)
FDA Class 2
·Hematology
TI SCREW ES
FDA UDI
Biomet Sports Medicine, LLC·00880304008434·
CEEON EASYSERT INTRAOCULAR LENS INJECTOR, MODEL IMP-1
FDA 510(k)
FDA Class 1
·Ophthalmic
SYNTHES (USA) 2.4MM VA-LCP TWO-COLUMN NARROW VOLAR DISTAL RADIUS
FDA 510(k)
FDA Class 2
·Orthopedic
PERMACOL 10X15 1.5MM
FDA Adverse Event
Death
·COVIDIEN, FORMERLY TISSUE SCIENCE LABORATORIES, PLC·Product code FTL·September 3, 2013
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 8, 2014
RIATA ACTIVE FIXATION
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·January 8, 2013
LUMAX 340 VR-T
FDA Adverse Event
Injury
·BIOTRONIK SE & CO. KG·Product code LWS·November 12, 2010
3.0MM TI-SCREWANCHOR1BLUE SUTU
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code MBI·May 4, 2018
3.0MM TI-SCREWANCHOR1BLUE SUTU
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code MBI·March 15, 2018
3.0MM TI-SCREWANCHOR1BLUE SUTU
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code MBI·March 12, 2018
3.0MM TI-SCREWANCHOR1BLUE SUTU
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code MBI·May 4, 2018
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