13 results · 22ms · Sources: EU EUDAMED, US FDA

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SMITH & NEPHEW MIS HIP STEM WITH STIKTITE

FDA 510(k)
FDA Class 2 ·Orthopedic

Conformis Hip System

FDA UDI
Conformis, Inc.·00850268007934·REAMER, ACETABULAR, 44MM FULL

RZ Medizintechnik GmbH

FDA UDI
RZ-Medizintechnik GmbH·04049197541381·Ferreira Style Breast Retractor 80x25m...

LINEAR ST

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·August 6, 2021

EUROSPITAL EU-TTG IGA UMANA

FDA 510(k)
FDA Class 2 ·Immunology

SCANDINAVIAN IVF SCIENCES AB, G1.2

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

PLATE,FIXATION,BONE

FDA Adverse Event
Malfunction ·SYNTHES USA·Product code HRS·May 9, 2014

DVT CALF GARMENTS STANDARD

FDA Adverse Event
Injury ·ARJOHUNTLEIGH POLSKA SP. ZO.O.·Product code JOW·April 4, 2013

RIGIDFIS 3.3 MM ST CROSS PIN

FDA Adverse Event
Injury ·DEPUY MITEK·Product code MBI·April 25, 2011

SYNERGY BALLOON DILATATION CATHETER

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC·Product code LIT·July 22, 2008

Infant reusable blood pressure cuffs, one tube, male slip luer connector, P/N 2930 , manufactured for Welch Allyn Protocol, Inc. and labeled in part: '***Reusable Blood Pressure Cuffs Infant 50 Cuffs REF 008-0625-00 PROTOCOL SYSTEMS, INC. Beaverton, OR 97008-7107 USA Assembled in Mexico***.'

FDA Recall
Terminated ·GE Medical Systems Information Technologies·March 7, 2001

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

CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024