33 results
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26ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MEDTRONIC EXTENSION PASSER TUNNELING SYSTEM (38 CM), MODEL 3555-38; MEDTRONIC EXTENSION PASSER TUNNELING SYSTEM (60 CM),
FDA 510(k)
FDA Class 2
·Neurology
SABLE - Kavo Multiflex
FDA UDI
Sable Industries Inc·00841359050052·SABLE - KAVO Multiflex Type 5-Hole Coupler
eWave 6-Lead EKG
FDA UDI
Wearlinq, Inc.·K00010·Continuous wearable electrocardiogram (ECG) mon...
Golden Isles Pedicle Screw System
FDA UDI
Intelivation, LLC·G079C5020001050·Tap, Double Lead, Ø10.5mm
Mariner Outrigger
FDA UDI
Seaspine Orthopedics Corporation·10889981172657·Axial, Closed, 105mm
Golden Isles Pedicle Screw System
FDA UDI
Intelivation, LLC·G079C2520001050·Curved Ti Rod, 105mm
PediFlex
FDA UDI
ORTHOPEDIATRICS CORP.·00841132133279·POST - SLIDING, F-TOOL
RUMI II,BACKLOADABLE
FDA Adverse Event
Malfunction
·COOPERSURGICAL, INC.·Product code LKF·June 14, 2023
Taurus Pedicle Screw System
FDA UDI
SINTX Technologies, Inc.·M555500000105·Taurus Implant Case- Base
DELTA-TT ACETABULAR CUP Ø54 MM
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A.·Product code LPH·August 26, 2021
FlowLogic Agile
FDA UDI
SONENDO, INC.·00810209420079·FlowLogic Agile Shaping File 15/.04, 21mm
CURE 2.0™ ACP
FDA UDI
MEDITECH SPINE, LLC·B167T21000001050·
BARCOMED 2MP2
FDA 510(k)
FDA Class 2
·Radiology
IMMULITE VALPROIC ACID, IMMULITE 2000 VALPROIC ACID, CATALOG # LKVA1, LKVA5 & L2KVA2, L2KVA6
FDA 510(k)
FDA Class 2
·Clinical Toxicology
6000105-1999-00002
FDA Adverse Event
Malfunction
·December 22, 1999
6000105-1999-00001
FDA Adverse Event
Malfunction
·December 22, 1999
A.T.S.® 3000
FDA UDI
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.·00889024209091·A.T.S. 3000 LOP Sensor Assembly
ADVANCE(R) DRILL BIT W/QUICK DISCONNECT***
FDA Adverse Event
Malfunction
·MICROPORT ORTHOPEDICS INC.·Product code LXH·August 1, 2014
ADVANCE(R) UNI POSTERIOR RESECTION BLOCK***
FDA Adverse Event
Malfunction
·MICROPORT ORTHOPEDICS INC.·Product code LXH·August 1, 2014
VASCUTRAK 2 PTA BALLOON DILATATION CATHETER
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code DQY·February 8, 2013