14 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PADPRO SYSTEM DEFIBRILLATOR ELECTRODE ADAPTERS
FDA 510(k)
FDA Class 3
·Cardiovascular
Custom Procedure Kit
FDA UDI
MEDIVATORS INC.·40677964023567·The ENDO CARRY-ON Procedure Kit contains all of...
GEN4 DIGITAL
FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828109840·GEN4 DIGITAL
NorthStar
FDA UDI
Seaspine Orthopedics Corporation·10889981196127·Poly. Screw, 3.5mm x 48mm
Genio System 2.1
FDA UDI
Nyxoah·05404031024755·The Genio External Stimulator Sales Kit include...
FETAL ASSIST
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
MODULAR ROTATING HINGE KNEE CROSSOVER TIBIAL BEARING COMPONENTS
FDA 510(k)
FDA Class 2
·Orthopedic
TI MULTI VECTOR DISTRACTOR BODY
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code DZL·February 28, 2013
DEPUY PINNACLE HIP/SECTOR II CUP, 60MM
FDA Adverse Event
Injury
·Product code LPH·February 19, 2011
PRECISE OTW NITINOL STENT
FDA Adverse Event
Injury
·CORDIS DE MEXICO·Product code NIM·February 25, 2008
Torque Limiting Adapter: Torque Limiting Attachment, Non Sterile, Distributed by Zimmer. PRECIMED, Torque Limiting Adaptor, Non Sterile.. Customer Number/Model: 00-2360-080-00 T10232, T116245 T116245, TLA025-25 TLA025-25, 00-2360-080-05 T10233, MAC21003 T116430, TLA025-30 TLA025-30, MAC21001 T112972, MAC21001 T13621, TLA025-20 TLA025-20.
FDA Enforcement
Class II
·Terminated·Greatbatch Medical·June 8, 2016
smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD, Inc.·December 4, 2024
e.cam Gamma Camera, an emission computed tomography system. It is intended to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·November 11, 2015
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020