22 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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HEALIX ADVANCE BR ANCHOR
FDA 510(k)
FDA Class 2
·Orthopedic
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197029025·Iris Scissors
straig...
EXACTECH RESORBABLE BONE PASTE
FDA 510(k)
FDA Class 2
·Orthopedic
MODIFIED STRAIGHT FIRE LASER FIBER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Widex
FDA UDI
Widex A/S·05706069923193·WIDEX MOMENT MBB3D 220 (Mediterranean turquoise)
Trilogy®
FDA UDI
Zimmer, Inc.·00889024361423·
NA
FDA UDI
Zimmer, Inc.·00889024186774·
Trilogy®
FDA UDI
Zimmer, Inc.·00889024361447·
Widex
FDA UDI
Widex A/S·05706069971996·WIDEX MOMENT MBB2 220 (Mediterranean turquoise)
Widex
FDA UDI
Widex A/S·05706069806281·Widex EVOKE E-FA (Mediterranean turquise ) 220,...
Trilogy®
FDA UDI
Zimmer, Inc.·00889024116801·
Trilogy®
FDA UDI
Zimmer, Inc.·00889024361430·
Widex
FDA UDI
Widex A/S·05706069884289·WIDEX MOMENT MRR2D (Mediterranean turquise ) 22...
Widex
FDA UDI
Widex A/S·05706069817232·Widex UNIQUE U-FA (Mediterranean turquise ) 220...
TRANSPORT SERIES OBS10/25/04
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FPO·May 20, 2013
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 25, 2014
AED PRO
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORP·Product code MKJ·May 26, 2011
1) Accolade II 127 Neck Angle Hip Stem, Size # 3 2) Accolade II 127 Neck Angle Hip Stem, Size #5 Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 USA Telephone # +1 201-831-5000 Stryker France ZAC Satolas Green Pusignan Av de Satolas Green 69881 MEYZIEU Cedex France Intended for cementless application in total or hemiarthroplasty procedures.
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·December 18, 2013
MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-000005-01R , MON-000006 , MON-000006-RFB, MON-000008 with software
FDA Enforcement
Class II
·Ongoing·Auris Health, Inc·February 25, 2026
Monarch Platform (Endoscopy), REF: MON-000005-01, MON-000005-01R. Monarch Platform (Bronchoscopy), REF: MON-000006, MON-000006-RFB.
FDA Enforcement
Class II
·Ongoing·AURIS HEALTH INC·October 16, 2024