22 results · 22ms · Sources: EU EUDAMED, 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