21 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MODEL 5000 MULTIPLACE HYPERBARIC THERAPY
FDA 510(k)
FDA Class 2
·Anesthesiology
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·H65810027941·Feathered Gutta Percha Pts CC
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·10304040140533·Feathered Gutta Percha Pts CC
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·00304040099629·Feathered Gutta Percha Pts CC
GRADIA®
FDA UDI
Gc America Inc.·D0470027941·GRADIA® DIRECT X Unitips - 10 tips 0.16 mL/0.30...
GRADIA®
FDA UDI
Gc America Inc.·14548161322331·GRADIA® DIRECT X Unitips - 10 tips 0.16 mL/0.30...
MODIFICATION TO MARSPO2, MODEL 2001
FDA 510(k)
FDA Class 2
·Cardiovascular
EBI ANTERIOR CERVICAL PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
RESTORE ADVANCED
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LGW·May 15, 2012
FOXCROSS PTA CATHETER
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code LIT·March 13, 2013
ACCU-CHEK SPIRIT COMBO
FDA Adverse Event
Malfunction
·ROCHE INSULIN DELIVERY SYSTEMS, INC.·Product code LZG·February 8, 2011
CELL-DYN SAPPHIRE ANALYZER
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS DIVISION/CELLDYN·Product code GKZ·February 26, 2008
Stryker End Cap, Standard T2 Humerus ¿6 mm Catalog Number: 18300003S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
FDA Enforcement
Class II
·Terminated·Stryker GmbH·June 24, 2020
VUELOCK SCREW, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code KWQ·April 16, 2020
VEULOCK SCREW, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code KWQ·April 16, 2020
VEULOCK SCREW, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code KWQ·April 16, 2020
VUELOCK PLATE, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code KWQ·April 16, 2020
VEULOCK SCREW, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code KWQ·April 16, 2020
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/11 MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·December 22, 2022
Dynamic Locking Screw System (DLS) 3.7mm & Dynamic Locking Screw (DLS) 5.0mm; intended for use in long bone fractures, the fixation of osteopenic bone, the fixation of osteotomies, and for the fixation of non-unions and malunions.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·September 30, 2015