28 results · 21ms · Sources: EU EUDAMED, US FDA

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CASPIAN SPINAL SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

Sasmar Vanilla

FDA UDI
Sasmar Pharmaceuticals SPRL·09337213008266·PERSONAL LUBRICANT

Ultra-Pro e™ Variable Angle Needle Guide

FDA UDI
CIVCO MEDICAL INSTRUMENTS CO., INC.·10841436101964·Sterile needle guide with (14 x 147cm) telescop...

SAVANNAH

FDA UDI
SPINAL ELEMENTS·00840916150051·MISCELLANEOUS CADDY 4.00 X 7.40 X 1.13IN

Endo Carry-On Procedure Kit

FDA UDI
MEDIVATORS INC.·00677964074684·Endo Carry-On Procedure Kit

Endo Carry-On Procedure Kit

FDA UDI
MEDIVATORS INC.·00677964077876·Endo Carry-On Procedure Kit

SYRINGE 60ML E/T

FDA Adverse Event
Malfunction ·Product code FMF·August 24, 2021

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code KWP·June 10, 2020

MANDREL GUIDEWIRE ASSEMBLY

FDA 510(k)
FDA Class 2 ·Cardiovascular

TRANS FX ADJUSTABLE PIN TO BAR CLAMP

FDA 510(k)
FDA Class 2 ·Orthopedic

INFUSE BONE GRAFT

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·January 5, 2018

DURATA STS OPTIM ACTIVE FIXATION

FDA Adverse Event
Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·May 9, 2013

SOFTCLIX ® LANCET DEVICE

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·May 24, 2011

CARPENTIER-EDWARDS PORCINE AORTIC BIOPROSTHESIS

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES·Product code LWR·August 4, 2008

SUBCUTANEOUS, UNIPOLAR LEAD

FDA Adverse Event
Malfunction ·MPRI·Product code LWS·May 21, 2025

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code NKB·April 19, 2019

Battery Power Line II Battery Oscillator, DePuy Synthes Power Tools, The Anspach Effort Inc.

FDA Enforcement
Class II ·Terminated·The Anspach Effort, Inc.·July 13, 2016

Sensis/ Sensis Vibe systems with software VD1X as follows: (1)Sensis Model 10764561 (2) Sensis Vibe Hemo Model 11007641 (3)Sensis Vibe Combo Model 11007642 Intended Use: A diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies

FDA Enforcement
Class II ·Ongoing·Siemens Medical Solutions USA, Inc·November 24, 2021

TherMax Blood Warmer Unit

FDA Enforcement
Class II ·Terminated·Baxter Healthcare Corporation·November 6, 2019

INTUA CRT-P, Model Numbers: a) V272 b) V273 c) W273

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021