20 results
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37ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Ergoline Prestige 1600 Hybrid Performance
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Comprehensive® Reverse Shoulder
FDA UDI
Biomet Orthopedics, LLC·00880304677180·
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197453271·CCR Titanium Longitudinal Blade
24x55m...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197083591·SWEDISH Pattern TC Needle Holder
200mm,...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197083539·PAR TC Needle Holder, straight, serrated
11.5cm...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197083607·SWEDISH Pattern TC Needle Holder
250mm,...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197083560·SWEDISH Pattern TC Needle holder
15cm, ...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197083577·SWEDISH PATTERN TC Needle Holder
170mm,...
SOFIA AUTOMATED TOMOGRAPHIC ULTRASOUND (ATUS)
FDA 510(k)
FDA Class 2
·Radiology
APEX-LNK ACETABULAR INSERT, E, APEX-LNK ACETABULAR INSERT, F, APEX-LNK
FDA 510(k)
FDA Class 2
·Orthopedic
M7 CONICAL MALLET ADAPTOR
FDA Adverse Event
Injury
·ORTHOFIX SRL·Product code HSB·February 11, 2021
LIFECARE XL
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·October 15, 2014
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·June 20, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 27, 2011
PREVENA PLUS INCISION MANAGEMENT SYSTEM
FDA Adverse Event
Injury
·KINETIC CONCEPTS, INC·Product code OMP·September 24, 2021
MODIFIED NOVY CORNUAL CANNULATION SET
FDA Adverse Event
Malfunction
·COOK INC·Product code MOV·March 14, 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