13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LEUCADIA AUTOLOK PEDICLE SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
CapSure® Spine System
FDA UDI
Spine Wave, Inc.·10840642104646·PS3 Screw 10.5mm x 120mm
SCREW,FIXATION,BONE
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code HWC·June 9, 2017
PROLITE PULSED LIGHT SYSTEM FOR THE REMOVAL OF UNWANTED HAIR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
RT600
FDA 510(k)
FDA Class 2
·Neurology
BD¿ LUER-LOK SYRINGE 60 ML
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·January 25, 2022
IMPAX CV OUTBOUND (RESULTS MANAGEMENT 2.08)
FDA Adverse Event
Malfunction
·AGFA HEALTHCARE CORP·Product code LLZ·February 28, 2014
LIGACLIP
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC.·Product code FZP·May 7, 2013
ASR ACETABULAR CUPS 54
FDA Adverse Event
Injury
·DEPUY INTL., LTD.·Product code KWA·May 20, 2011
BD NEXIVA¿ CLOSED IV CATHETER SYSTEM
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FOZ·March 8, 2018
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES SELZACH·Product code HWC·June 2, 2015
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES SELZACH·Product code HWC·June 3, 2015
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021