44 results
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12ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
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Extremities Item Number: 1)113954 Hybrid Glenoid Glenoid Base, 4 MM 2) XL-115366 Comprehensive Reverse Shoulder Humeral Bearing, ArComXL, 44 MM X 41 MM, Standard 3) XL-115364 Comprehensive Reverse Shoulder Humeral Bearing, ArComXL, 44 MM X 36 MM, +3MM Standard Product Usage: is indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·June 3, 2020
Extremities Item Number: 1)113954 Hybrid Glenoid Glenoid Base, 4 MM 2) XL-115366 Comprehensive Reverse Shoulder Humeral Bearing, ArComXL, 44 MM X 41 MM, Standard 3) XL-115364 Comprehensive Reverse Shoulder Humeral Bearing, ArComXL, 44 MM X 36 MM, +3MM Standard Product Usage: is indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff.
FDA Recall
Terminated
·Biomet, Inc.·Product code PHX·April 17, 2020
VITEK 2 System, VITEK 2 XL 110V (Catalog #27227) and VITEK 2 XL 220V (Catalog #27228). VITEK 2 is an automated system consisting of instruments, software, and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. The system is intended for use to perform in vitro diagnostic organism identification and antimicrobial susceptibility testing in human applications.
FDA Recall
Terminated
·Biomerieux Inc·Product code LTW·June 2, 2011
AAMI 3 FABRIC REINFORCEDGown 2XL NS, Item Code 9571NA
FDA Recall
Terminated
·Cardinal Health·Product code FYA·January 11, 2020
AAMI 3 NONREINF SURGICAL GOWN 3XL, Item Code 9585
FDA Recall
Terminated
·Cardinal Health·Product code FYA·January 11, 2020
AAMI 3 ROYALSILK SURGGOWN BNS 2XL, Item Code 9578NB
FDA Recall
Terminated
·Cardinal Health·Product code FYA·January 11, 2020
AAMI 3 NONREINF SURG GOWN 2XL XLONG, Item Code 9575EL
FDA Recall
Terminated
·Cardinal Health·Product code FYA·January 11, 2020
AAMI 3 FABRIC REINF SURG GOWN 2XL, Item Code 9571
FDA Recall
Terminated
·Cardinal Health·Product code FYA·January 11, 2020
AAMI 3 NONREINF SURG GOWN 3XL BNS, Item Code 9585N
FDA Recall
Terminated
·Cardinal Health·Product code FYA·January 11, 2020
AAMI 3 NON-REINF SURG GOWN 2XL BNS, Item Code 9575NB
FDA Recall
Terminated
·Cardinal Health·Product code FYA·January 11, 2020
AAMI 3 NON-RNF SURG GOWN 3XL LONG, Item Code 95995N
FDA Recall
Terminated
·Cardinal Health·Product code FYA·January 11, 2020
AAMI 3 NONRNF SURG GWN 2XL XLNG BNS, Item Code 9575ELNA
FDA Recall
Terminated
·Cardinal Health·Product code FYA·January 11, 2020
AAMI 3 NON-REINF SURG GWN 3XL XLONG, Gown. Item Code 95995
FDA Recall
Terminated
·Cardinal Health·Product code FYA·January 11, 2020
VITEK 2 (version numbers 8.01, 8.02 (8.0x) and 9.01, 9.02 (9.0x) with the external communication configured to HL7 (system, test, automated, antimicrobial susceptibility, short incubation). VITEK 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. The VITEK 2 utilizes growth-based biochemical patterns to determine identification. The VITEK 2 provides minimal inhibitory concentration (MIC) results for most organism/drug combinations as well as a category interpretation (S, I, or R) consistent with accepted criteria.
FDA Enforcement
Class II
·Terminated·Biomerieux Inc·March 31, 2021
AAMI 3 NONREINF SURGICAL GOWN 3XL, Item Code 9585
FDA Enforcement
Class II
·Terminated·Cardinal Health·February 12, 2020
AAMI 3 FABRIC REINFORCEDGown 2XL NS, Item Code 9571NA
FDA Enforcement
Class II
·Terminated·Cardinal Health·February 12, 2020
AAMI 3 ROYALSILK SURGGOWN BNS 2XL, Item Code 9578NB
FDA Enforcement
Class II
·Terminated·Cardinal Health·February 12, 2020
AAMI 3 NONREINF SURG GOWN 2XL XLONG, Item Code 9575EL
FDA Enforcement
Class II
·Terminated·Cardinal Health·February 12, 2020
AAMI 3 FABRIC REINF SURG GOWN 2XL, Item Code 9571
FDA Enforcement
Class II
·Terminated·Cardinal Health·February 12, 2020
AAMI 3 NONREINF SURG GOWN 3XL BNS, Item Code 9585N
FDA Enforcement
Class II
·Terminated·Cardinal Health·February 12, 2020