19 results
·
33ms
·
Sources: EU EUDAMED, US FDA
Pentax Medical Valve Set
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
LUPINE ORTHOCORD
FDA UDI
DEPUY MITEK, LLC·10886705008582·LUPINE LOOP ANCHOR Poly Lactic Acid Absorbable ...
MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
GLIDESHEATH SLENDER MODEL RM* ES6J10HQS, GLIDESHEATH SLENDER MODEL RM* ES6F16HQ, GLIDESHEATH SLENDER MODEL RM * RS6J10PQ
FDA 510(k)
FDA Class 2
·Cardiovascular
SYRINGE 3ML LL 200 S/C
FDA Adverse Event
Malfunction
·BECTON DICKINSON DE MEXICO·Product code FMF·July 9, 2019
LUPINE LOOP O-C VIOLET *EA
FDA Adverse Event
Malfunction
·DEPUY MITEK LLC US·Product code MAI·July 26, 2018
PINNACLE 300 ACET CUP 50MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·February 19, 2013
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY NELLCOR·Product code CBK·August 10, 2011
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·August 6, 2014
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 12, 2013
ASPHERE M SPEC 12/14 36 -2
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·November 17, 2012
PINNACLE MTL INS NEUT36IDX50OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·November 17, 2012
ASPHERE M SPEC 12/14 36 -2
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·November 17, 2012
PINNACLE MTL INS NEUT36IDX50OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·November 17, 2012
LUPINE DRILL GUIDE
FDA Adverse Event
Malfunction
·DEPUY MITEK·Product code HRX·October 5, 2009
Depuy Mitek- Lupine Loop O-C violet Catalog Number: 222980 The Lupine Anchor System is indicated for use in soft tissue bone fixation.
FDA Recall
Terminated
·DePuy Mitek, Inc., a Johnson & Johnson Co.·Product code MAI·January 27, 2012
DePuy Mitek Panalock Loop w/ Orthocord Catalog #222980 The LUPINE BR Anchor System is indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization.
FDA Recall
Terminated
·DePuy Mitek, Inc., a Johnson & Johnson Co.·Product code MAI·October 31, 2011
Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcutaneous infusion of medication.
FDA Enforcement
Class II
·Terminated·Unomedical As·July 1, 2015
SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels
FDA Enforcement
Class I
·Terminated·Zimmer Biomet, Inc.·November 7, 2018