31 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ARTHREX KNOTLESS SUTURETAK ANCHOR
FDA 510(k)
FDA Class 2
·Orthopedic
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780180043·Integra® Jarit® Olsen-Hegar Needle Holder, 6-3/4"
PMT® CORPORATION HALO
FDA UDI
PMT CORPORATION·00650551044925·HEADHOLDER, FOR ATTACHING OPEN BACK RINGS
Diversatek Healthcare
FDA UDI
DIVERSATEK HEALTHCARE, INC.·M7831201550·Endoscopy Basic Procedure Kit
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197539937·Caspar Laminectomy Ronguer downwards ang
led 5x...
Cortium Universal OCT Spinal Fixation System
FDA UDI
Ulrich Medical Usa, Inc.·00814386028301·Tap, Ø 5.5mm, thoracic, AO coupling, cannulated...
TRUVUE WIRELESS AMBULATORY ECG MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
DYNA-LOK CLASSIC SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
TOTAL FEMUR
FDA Adverse Event
Injury
·STANMORE IMPLANTS WORLDWIDE·Product code KRO·June 7, 2018
IN00087 CLERMONT FERRAND PH
FDA Adverse Event
Death
·SORIN GROUP ITALIA·Product code DWF·March 7, 2014
CUSTOM TOTAL FEMUR REPLACEMENT IMPLANT
FDA Adverse Event
Injury
·STANMORE IMPLANTS WORLDWIDE LTD.·Product code KRO·December 24, 2014
ENDURO MENISCAL COMPONENT F2 22MM
FDA Adverse Event
Malfunction
·AESCULAP AG & CO. KG·Product code KRO·December 9, 2014
AccessPLUS Large Bore Hemostasis Valves, Catalog Code: 580758001, 580774001, IN8152/C, K04-01197, K05T-01863, K09-09102B, K09-10388A, K09-12917, K09-13501AP, K10-05457AP, K10-05635, K10-05868P, K10-05872P, K12-08303, K12-10346, K12-10375, K12-10724AP, K12-10962, K12-11413, MAP150/F, MAP152/B, MAP152/F, K12-01551, K12-YP064A, K12-YP114, K12-YP115, K12-YS047A, IN8152, K12-01551
FDA Enforcement
Class II
·Ongoing·Merit Medical Systems, Inc.·April 20, 2022
ENDURO MENISCAL COMPONENT F2 10MM
FDA Adverse Event
Malfunction
·AESCULAP AG AND CO. KG·Product code KRO·January 14, 2015
ASR ACETABULAR IMPLANT 56
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·May 20, 2013
ATTAIN OTW
FDA Adverse Event
Death
·MPRI·Product code LWP·September 25, 2014
KINETRA
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code MHY·June 6, 2011
CUSTOM TOTAL FEMUR REPLACEMENT
FDA Adverse Event
Malfunction
·STANMORE IMPLANTS WORLDWIDE LTD·Product code JDI·July 24, 2015
INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DTZ·January 7, 2016
AccessPLUS Large Bore Hemostasis Valves, Catalog Code: 580758001, 580774001, IN8152/C, K04-01197, K05T-01863, K09-09102B, K09-10388A, K09-12917, K09-13501AP, K10-05457AP, K10-05635, K10-05868P, K10-05872P, K12-08303, K12-10346, K12-10375, K12-10724AP, K12-10962, K12-11413, MAP150/F, MAP152/B, MAP152/F, K12-01551, K12-YP064A, K12-YP114, K12-YP115, K12-YS047A, IN8152, K12-01551
FDA Recall
Open, Classified
·Merit Medical Systems, Inc.·Product code DTL·March 1, 2022