131 results
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26ms
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Sources: EU EUDAMED, US FDA
PROMATRON 3000
FDA 510(k)
FDA Class 2
·Physical Medicine
Printed Lower ROC Pack for Herbst LR5 14mm
FDA UDI
SPECIALTY APPLIANCES, LLC·D8199015660·
Map-iT
FDA UDI
ACCESS POINT TECHNOLOGIES, INC.·00818083010577·Fixed, 10 electrode, CS, 2-8-2mm electrode spacing
Elite®Opti-MIM® Bondable Buccal Tubes
FDA UDI
Ortho Organizers, Inc.·00190707069957·.022 LL SOLO TUBE -25T OPTI-MIM DB
ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS
FDA 510(k)
FDA Class 2
·Orthopedic
VITEK 2 YEAST CASPOFUNGIN
FDA 510(k)
FDA Class 2
·Microbiology
BONE SPREADER 12MM BEAK WIDTH
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HWN·April 18, 2024
AMISTEM-P STD STEM SIZE 5
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·April 15, 2020
CALCIUM GEN. 2
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code CHW·June 30, 2014
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·November 10, 2010
HS III PROXIMAL SEAL SYSTEM 3.8MM
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC·Product code DXC·January 4, 2013
LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 5, RIGHT, REF 71426005, QTY 1, Smith & Nephew, knee prosthesis Usage:orthopedic.
FDA Recall
Terminated
·Smith & Nephew, Inc.·Product code JWH·November 4, 2014
LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 6, LEFT, REF 71426006, QTY 1, Smith & Nephew, knee prosthesis Usage:orthopedic.
FDA Recall
Terminated
·Smith & Nephew, Inc.·Product code JWH·November 4, 2014
LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 4, LEFT, REF 71425004, QTY 1, Smith & Nephew, knee prosthesis Usage:orthopedic.
FDA Recall
Terminated
·Smith & Nephew, Inc.·Product code JWH·November 4, 2014
smith&nephew Mini-Fragment Plating System, VLP(R) Mini-Mod Small Bone Plating System, EVOS(R) Mini Plating system, 2.0MM STRAIGHT PLATE, 8 HOLE VLP(R) MIN-MOD, REF 74442024, QTY: (1), STERILE R Bone plates and bone screws from the Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System (VLP MINI-MOD) are intended for use in internal fixation of small bones and small bone fragments and non-load bearing stabilization and reduction of bone fragments in long bones.
FDA Recall
Terminated
·Smith & Nephew, Inc.·Product code HRS·December 11, 2017
smith&nephew Mini-Fragment Plating System, VLP(R) Mini-Mod Small Bone Plating System, EVOS(R) Mini Plating system, 2.0MM STOUT STRAIGHT PLATE, 8 HOLE VLP(R) MIN-MOD, REF 74442030, QTY: (1), STERILE R Bone plates and bone screws from the Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System (VLP MINI-MOD) are intended for use in internal fixation of small bones and small bone fragments and non-load bearing stabilization and reduction of bone fragments in long bones.
FDA Recall
Terminated
·Smith & Nephew, Inc.·Product code HRS·December 11, 2017
Smith & Nephew Dyonics Saw Blade, Long, Special, Product Number 3706
FDA Recall
Terminated
·Smith & Nephew, Inc.·Product code HAB·February 2, 2017
Smith & Nephew Dyonics Saw Blade, Short, Product Number 3703
FDA Recall
Terminated
·Smith & Nephew, Inc.·Product code HAB·February 2, 2017
Smith & Nephew Dyonics Saw Blade, Narrow, Product Number 3705
FDA Recall
Terminated
·Smith & Nephew, Inc.·Product code HAB·February 2, 2017
Smith & Nephew Dyonics Saw Blade, Standard, Product Number 3701
FDA Recall
Terminated
·Smith & Nephew, Inc.·Product code HAB·February 2, 2017