14 results
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20ms
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Sources: EU EUDAMED, US FDA
INOVEL HEALTH CARE MODEL N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Medstone
FDA UDI
Stille AB·07332339231101·Set of 2 UDI products as a convenience kit
MODIFIED MOSS MIAMI 4.35MM DIAMETER POLYAXIAL SCREWS
FDA 510(k)
FDA Class 2
·Orthopedic
MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP-3BU1
FDA 510(k)
FDA Class 2
·Cardiovascular
GRAFTON DBM
FDA Adverse Event
Injury
·MEDTRONIC EATONTOWN·Product code NUN·July 6, 2019
SCORPIOFLEX TOTAL KNEE PS
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code JWH·September 14, 2018
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·April 10, 2013
COOK CELECT VENA CAVA FILTER
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE, APS·Product code DTK·May 22, 2008
SHILEY CUFFLESS FENESTRATED
FDA Adverse Event
Injury
·COVIDIEN/FORMERLY TYCO HEALTHCARE·Product code JOH·April 6, 2011
NEURO IR TRAY , Model No WENI56J
FDA Enforcement
Class II
·Ongoing·American Contract Systems Inc·March 26, 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
The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022
The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022
The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022