52 results
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15ms
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Sources: EU EUDAMED, US FDA
Grafton DMB Matrix, Model Numbers: a) T42200, b) T42210; Demineralized Bone Matrix
FDA Enforcement
Class II
·Ongoing·Medtronic Sofamor Danek USA Inc·November 1, 2023
Bacterin International, Inc., Osteoselect Demineralized Bone Matrix DMB Putty; Graft ID# B090056-664 Donor# B090056 2.5cc Expiration Date: 12/25/2011; LBL 210-0010-1 REV: 040109; and Graft ID# B090056-675. Bone void filler for voids or gaps in bone. Indicated for treatment of surgically created osseous defects. On 07/12/2012 an additional expired product was discovered by a Bacterin sales rep. B100078-908 with expiration date 04/27/2012
FDA Enforcement
Class II
·Terminated·Bacterin International, Inc.·February 20, 2013
JUGGERKNOT 2.9MM 2 #2 MB Product Usage: For use in hip arthroplasty
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·March 21, 2018
VITROS Immunodiagnostic VITROS Folate Reagent Pack 1/2
FDA Enforcement
Class II
·Ongoing·Ortho-Clinical Diagnostics, Inc.·August 21, 2024
KliniTray Platte Faxitron ,groB "R" sterile. Tissue resection margin examination board/large Model Number: 2001155-F The medical device KliniTrayTM is a system for the precise monitoring, recording and visualization of alignment during surgical procedures. It ensures the exact orientation and positioning of tissue to be removed in the patient's body, enabling improved surgical precision and patient safety.
FDA Enforcement
Class II
·Ongoing·Klinika Mdical Gmb·May 21, 2025
KliniTray. KlinioTray. Tissue resection margin examination board/small. Model Number: 2001105-F The medical device KliniTrayTM is a system for the precise monitoring, recording and visualization of alignment during surgical procedures. It ensures the exact orientation and positioning of tissue to be removed in the patient's body, enabling improved surgical precision and patient safety.
FDA Enforcement
Class II
·Ongoing·Klinika Mdical Gmb·May 21, 2025
ProScreen 10 Drug Panel Cassette Test, Item No. CPSP-10PPX; ProScreen 10 Panel Cup, Item No. PSCup-10MMO-300, PSCup-10M, PSCupA-10MO, PSCUp-10AB; ProScreen 10 Panel Cup with Adulterants, Item No. PSCupA-10AM; ProScreen 10 Panel Dip Card, Item No. PSD-10MMO-300, PSD-10MOX, PSD-10M, PSD-10CMO3, PSD-10APO-300; ProScreen 10 Panel Dip Card w/Adult, Item No. PSDA-10MO, PSDA-10MMO-300; ProScreen 11 Panel Dip Card, Item No. PSD-11MT; ProScreen 12 Drug Cup w/Adulteration, Item No. PSCupA-12TBU; ProScreen 12 Panel Cup w/Adult., Item No. PSCupA-12M, PSCupA-12PP; ProScreen 12 Panel Dip Card, Item No. PSD-12BUP ProScreen 5 Panel Dip Card, Item No. PSD-5MB; ProScreen 5 Panel Dip Card w/Adult, Item No. PSDA-5MB-300; ProScreen 6 Panel Cassette w/Adult (AU), Item No. PSPA-6MBAU; ProScreen 6 Panel Cup w/Adult (AU), Item No. PSCupA-6MBAU; ProScreen 6 Panel Dip Card, Item No. PSD-6MBO, PSD-6MTDBO-300, PSD-6MB, PSD-6BUPO; ProScreen 7 Panel Dip Card, Item No. PSD-7MO, PSD-7M; ProScreen 8 Panel Dip Card, Item No. PSD-8P; ProScreen 8 Panel Dip Card w/Adult, Item No. PSDA-8P; ProScreen 9 Panel Dip Card, Item No. PSD-9P; ProScreen CLIA Waived Cup 6 Drugs w/Adul, Item No. PSCupA-6MB-W; ProScreen CLIA Waived Cup with 6 Drugs, Item No. PSCup-6BO-W; ProScreen CLIA Waived Cup with 8 Drug, Item No. PSCup-8P-W; ProScreen Cup, Item No. PSCup-6MB-W, PSCupA-6MB-W, PSCup-6BO-W, PSCup-8P-W, PSCUp-10AB, PSCup-10MMO-300; ProScreen Cup CLIA with 6 Panel Drug, Item No. PSCup-6MB-W; These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use. ¿¿¿
FDA Enforcement
Class II
·Terminated·Ameditech Inc·November 25, 2015
Radiography 7300 C; Model Number: 712037;
FDA Enforcement
Class II
·Ongoing·Philips Medical Systems DMC GmbH·November 19, 2025
DigitalDiagnost 4.1 High Performance (Stitching Patient Support) 712031
FDA Enforcement
Class II
·Terminated·Philips Medical Systems Gmbh, DMC·August 29, 2018
EasyDiagnost Eleva DRF (Stitching Patient Support) 706032
FDA Enforcement
Class II
·Terminated·Philips Medical Systems Gmbh, DMC·August 29, 2018
DigitalDiagnost 4 High Performance (Stitching Patient Support) 712027
FDA Enforcement
Class II
·Terminated·Philips Medical Systems Gmbh, DMC·August 29, 2018
DigitalDiagnost 4 Chest / Emergency (Stitching Patient Support) 712029
FDA Enforcement
Class II
·Terminated·Philips Medical Systems Gmbh, DMC·August 29, 2018
DigitalDiagnost Single Detector (Stitching Patient Support) 712020
FDA Enforcement
Class II
·Terminated·Philips Medical Systems Gmbh, DMC·August 29, 2018
CombiDiagnost R90 (Stitching Patient Support) 709030
FDA Enforcement
Class II
·Terminated·Philips Medical Systems Gmbh, DMC·August 29, 2018
DigitalDiagnost 2.x Upgrades (Stitching Patient Support) 712082
FDA Enforcement
Class II
·Terminated·Philips Medical Systems Gmbh, DMC·August 29, 2018
DigitalDiagnost Classic 1.x Upgrades (Stitching Patient Support) 712081
FDA Enforcement
Class II
·Terminated·Philips Medical Systems Gmbh, DMC·August 29, 2018
DigitalDiagnost 4.1 High Performance (Stitching Patient Support) 712031
FDA Enforcement
Class II
·Terminated·Philips Medical Systems Gmbh, DMC·August 29, 2018
DigitalDiagnost Dual Detector (Stitching Patient Support) 712022
FDA Enforcement
Class II
·Terminated·Philips Medical Systems Gmbh, DMC·August 29, 2018
DigitalDiagnost Release 3 (Stitching Patient Support) 712025
FDA Enforcement
Class II
·Terminated·Philips Medical Systems Gmbh, DMC·August 29, 2018
DigitalDiagnost Classic, Dual-Detector (Stitching Patient Support) 712052
FDA Enforcement
Class II
·Terminated·Philips Medical Systems Gmbh, DMC·August 29, 2018