11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Kitazato ET Catheters
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Phasix
FDA UDI
Davol Inc.·00801741107658·Phasix Mesh, 10" x 16" (25 cm x 40 cm), Rectangle
PIVOX™ Oblique Lateral Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169599314·TRIAL 2192540 O25 IB 27MM 12 DEG 16X40
EXPERIENCE®
FDA UDI
Gc Orthodontics America Inc.·D78819254000201·EXMRC MBT 022/U4 & 5 UNIV - 7T 0A
EXPERIENCE
FDA UDI
Gc Orthodontics America Inc.·D78819254000071·Exp CCO RH 022/U4&5 -9T 0A
PTFE PORTABLE INTRODUCER
FDA 510(k)
FDA Class 2
·Cardiovascular
C-PS PEEK OPTIMA CERVICAL INTERBODY SPACER, L-PS PEEK OPTIMA LUMBAR INTERBODY SPACER
FDA 510(k)
FDA Class 2
·Orthopedic
INTERMATE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code FRN·August 5, 2011
SCD EXPRESS COMPRESSION SYSTEM
FDA Adverse Event
Malfunction
·COVIDIEN·Product code JOW·June 19, 2013
HUT EXT DR FINAL ASSY-STANDARD
FDA Adverse Event
Malfunction
·LIEBEL FLARSHEIM·Product code IXR·October 22, 2014
SENSE XL TORSO COIL 1.5T. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model Numbers: 453567141882, 453567141883. Coils may be included in kits with Mode Numbers: 989603014351 & 989603014352.
FDA Enforcement
Class I
·Ongoing·Philips North America Llc·July 3, 2024