18 results
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26ms
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Sources: EU EUDAMED, US FDA
THE SPIRA ELEKTRO 2
FDA 510(k)
FDA Class 1
·Anesthesiology
GC Initial™
FDA UDI
Gc America Inc.·J0228711511·GC Initial™ LF Inside IN-51 Olive, 20g
GC Initial™
FDA UDI
Gc America Inc.·15400556705671·GC Initial™ LF Inside IN-51 Olive, 20g
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704292749·
Key Surgical K-Wires and Steinmann Pins
FDA UDI
KEY SURGICAL, INC.·00849771012504·K-Wires, Single trocar, .035-inch (.9mm) diamet...
NA
FDA UDI
KEY SURGICAL, INC.·10849771049088·K-Wires, Single trocar, .035-inch (.9mm) diamet...
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·14026704912381·
K-Wire w. trocar/round end 0.89mm/229mm, 6 pcs./unit
FDA UDI
mahe medical gmbh·EMAHKM711510·K-Wire w. trocar/round end
0.89mm...
mahe medical GmbH
FDA UDI
mahe medical gmbh·04050659484283·K-Wire w. trocar/round end _x000D_...
ORTHOSOURCE
FDA UDI
ORTHOSOURCE·D9118711510·Superb Detailing Step 1/4 mm
TENSION BAND ANTERIOR SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ACRON TLIF System
FDA 510(k)
FDA Class 2
·Orthopedic
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND·Product code CBK·April 14, 2014
ALTRUA
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·October 15, 2010
FENESTRATED BIPOLAR FORCEPS INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·December 12, 2012
BW Lasso 2515 ANV eco Variable Diagnostic EP Catheter, REF D134301 Diagnostic electrophysiology (EP) catheters are specially designed electrode catheters that transmit electrical impulses and can be positioned for endocardial recording or stimulation.
FDA Enforcement
Class II
·Terminated·Stryker Sustainability Solutions·January 30, 2019
SPRYSTEP VECTOR, Custom made device dynamic ankle-foot orthosis (AFO) , Reference numbers: 17V1030, 17V2030, 17V1031, 17V2031, 17V1032, 17V2032, 17V1033, 17V2033, 17V1035, 17V2035, 17V1036, 17V2036, 17V1037, 17V2037
FDA Enforcement
Class II
·Completed·Townsend Design·January 17, 2024
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015