71 results
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88ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and DENALI Mini) Spinal System, YUKON OCT Spinal System
FDA 510(k)
FDA Class 2
·Orthopedic
OsteoMed
FDA UDI
OSTEOMED LLC·00845694038928·1.6mm x 3.5mm Profile Zero AutoDrive Screw
Tasso+ Convenience Kit
FDA UDI
Tasso Inc.·00860006434564·Tasso+ convenience kit allows self-collection o...
NYOrtho APEX CORE Wheelchair Cushion Gel-Foam 18x16x3
FDA UDI
N.Y. ORTHOPEDIC USA, INC.·00811677015699·The NYOrtho APEX CORE Gel-Foam Cushion combines...
Paxeon Origin
FDA UDI
PAXEON RECONSTRUCTION LLC·08177570205042·
BEAUTIFIL FLOW PLUS
FDA 510(k)
FDA Class 2
·Dental
DIGITAL BALLISTOCARDIOGRAPH, MODEL DGB 300
FDA 510(k)
FDA Class 2
·Cardiovascular
ULTRATHANE COPE NEPHROURETEROSTOMY SET
FDA Adverse Event
Injury
·COOK INC·Product code FAD·February 22, 2022
SYNCHROMED II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·July 7, 2011
UNKNOWN IMPLANTABLE NEUROSTIMULATOR
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LGW·June 21, 2013
INSALL/BURSTEIN II MODULAR KNEE SYSTEM POSTERIOR STABILIZED CONDYLAR SERIES
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code JWH·September 29, 2008
BALL HEADS: MECTACER HEAD BIOLOX OPTION Ø 40
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·February 6, 2024
VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 58
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·July 28, 2023
SMS STEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·August 5, 2025
BALL HEADS: COCR BALL HEAD 12/14 Ø 36 SIZE M 0
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·June 1, 2023
VERSAFITCUP CC TRIO 01.26.3239HCT FLAT PE HC LINER Ø 32 / C
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·February 11, 2022
CUP: MPACT ACETABULAR SHELL 56 MULTI-HOLE
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·July 21, 2020
MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE L + 4
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·July 26, 2023
DOUBLE MOBILITY LINER
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·February 11, 2025
ULTRATHANE COPE NEPHROURETEROSTOMY SET
FDA Adverse Event
Injury
·COOK INC·Product code FAD·June 7, 2021