13 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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