18 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TEMP BASIC, TEMP PREMIUM, TEMP PREMIUM FLEXIBLE, MULTISTRATUM FLEXIBLE, THERAPON, TRY-IN, BURNOUT, TRY-IN & BURNOUT
FDA 510(k)
FDA Class 2
·Dental
Comprehensive® Reverse Shoulder
FDA UDI
Biomet Orthopedics, LLC·00880304677296·
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197083881·WANGENSTEEN TC Vascular needle holder
TC, 27...
LATITUDE ELBOW PROSTHESIS
FDA 510(k)
FDA Class 2
·Orthopedic
TELAMON PEEK SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
TELAMON FUSION DEVICE
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code MAX·August 5, 2016
TELAMON® FUSION DEVICE
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code MAX·August 3, 2012
TELAMON® FUSION DEVICE
FDA Adverse Event
Injury
·MSD DEGGENDORF MFG·Product code MAX·August 3, 2012
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·October 15, 2014
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 27, 2011
OPTICAP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SWINFORD·Product code KDJ·June 20, 2013
MODIFIED NOVY CORNUAL CANNULATION SET
FDA Adverse Event
Malfunction
·COOK INC·Product code MOV·March 14, 2024
LATITUDE ELBOW ANATOMIC HUMERAL SPOOL SZ PETIT+ SIDE GAUCHE
FDA Adverse Event
Injury
·TORNIER INC·Product code JDC·May 7, 2024
MODIFIED NOVY CORNUAL CANNULATION SET
FDA Adverse Event
Malfunction
·COOK INC·Product code MOV·January 10, 2024
MODIFIED NOVY CORNUAL CANNULATION SET
FDA Adverse Event
Malfunction
·COOK INC·Product code MOV·November 22, 2024
Comprehensive Reverse Shoulder System, Item numbers 115394, 115395, 115396, 115398, 180550, 180551, 180552, 180553, 180554, 180555, 180556, 180557, 180558, 180559, 180560, 180562 - Product Usage: indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthroplasty and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff The patient must anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·December 23, 2020
Comprehensive Reverse Shoulder System, Item numbers 115394, 115395, 115396, 115398, 180550, 180551, 180552, 180553, 180554, 180555, 180556, 180557, 180558, 180559, 180560, 180562 - Product Usage: indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthroplasty and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff The patient must anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary.
FDA Recall
Terminated
·Biomet, Inc.·Product code KWS·November 25, 2020
Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Product Usage: Boston Scientific cardiac resynchronization therapy defibrillators (CRT-Ds) are indicated for patients with moderate to severe heart failure who remain symptomatic despite stable, optimal heart failure drug therapy and have left ventricular dysfunction and QRS duration > or equal to 120 ms. This family of pulse generators provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Cardiac Resynchronization Therapy (CRT), which treats heart failure by resynchronizing ventricular contractions through biventricular electrical stimulation; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 29, 2014