16 results · 27ms · Sources: EU EUDAMED, US FDA

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STAR/VENT INTERNAL HEX SCREW IMPLANT

FDA 510(k)
FDA Class 2 ·Dental

JOBST Elvarex

FDA UDI
BSN-Jobst GmbH·04019702367614·ELVAREX 3/KNEE HIGH/SLANT-CLOSED TOE-ELEPHANTIA...

JOBST Elvarex

FDA UDI
BSN-Jobst GmbH·04019702248098·Elvarex 2/Thigh High/Slant-Open Toe-Elephantias...

primaLOK SP

FDA UDI
Wenzel Spine, Inc.·00813210021785·primaLOK SP 28mm Medium Boxless Implant, Steril...

VISIQUANT ANTI-NUCLEAR ANTIBODY TEST SYSTEM

FDA 510(k)
FDA Class 2 ·Immunology

SYMMETRIC UNICOMPARTMENTAL KNEE SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

SPINNING SPIROS® CLOSED MALE LUER, RED CAP

FDA Adverse Event
Malfunction ·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code FPA·November 4, 2025

45MM LEFT STANDARD MANDIBULAR

FDA Adverse Event
Malfunction ·BIOMET MICROFIXATION·Product code LZD·April 2, 2010

BD SYRINGE 1ML S/T BNS

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·June 18, 2024

10MM/130 DEG TI CANN TROCH FIXATION NAIL 235MM-STERILE

FDA Adverse Event
Malfunction ·SYNTHES MONUMENT·Product code HSB·April 29, 2013

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 11, 2014

SYNCHROMED II

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·May 3, 2011

BD SYRINGE 1ML S/T BNS

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·August 2, 2024

BD SYRINGE 1ML S/T BNS

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·August 2, 2024

On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

FDA Enforcement
Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014

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