14 results · 20ms · Sources: EU EUDAMED, US FDA

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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