22 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ADI Cervical Interbody Fusion Device
FDA 510(k)
FDA Class 2
·Orthopedic
Custom Healthcare Systems, Inc.
FDA UDI
Manus Medical, LLC·00811870033414·
Compression Staple System
FDA UDI
TORNIER, INC.·00846832058808·Staple
FRONTIER DEVICES CRANIOMAXILLOFACIAL, CRANIO CLOSURE, ORTHOGNATHIC, MANDIBLE RECONSTRUCTION AND MESH SYSTEMS
FDA 510(k)
FDA Class 2
·Dental
CONSTRUX MINI PEEK SPACER SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MECTACER BIOLOX DELTA FEMORAL BALL HEAD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·April 24, 2025
STEM: M-VIZION PROXIMAL BODY 20MM L 80MM STD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·May 17, 2021
STEM: M-VIZION PROXIMAL BODY Ø20MM L 60MM STD WITH HOLES
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·August 19, 2022
ZEPHYR XL DR
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code LWP·January 13, 2014
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·August 4, 2011
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·INVAMEX·Product code IOR·June 26, 2013
M-VIZION FEMORAL REVISION SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·July 29, 2025
M-VIZION FEMORAL REVISION SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·March 27, 2025
Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038301; Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
FDA Enforcement
Class I
·Ongoing·Medline Industries, LP·May 20, 2026
M-VIZION PROXIMAL BODY HANDLE
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code LXH·March 28, 2024
M-VIZION FEMORAL REVISION SYSTEM
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code LZO·May 28, 2026
STEM: M-VIZION PROXIMAL BODY 20MM L 50MM LAT
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·February 24, 2021
M-VIZION INSERTER ROD
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code LXH·May 28, 2024
M-VIZION FEMORAL REVISION SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·September 16, 2025
Dexcom G4 PLATINUM (Pediatric) Receiver Receiver Part Number: MT22430 Receiver (mg/dL), Black (pediatrics); MT22430-PNK, Receiver (mg/dL), Pink (pediatrics); MT22430-BLU, Receiver (mg/dL); Blue (pediatrics). Intended to detect trends and track glucose patterns in persons with diabetes.
FDA Enforcement
Class I
·Terminated·Dexcom Inc·April 20, 2016