41 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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HAC-12 AND HAC-30 HEAD ARRAY COIL
FDA 510(k)
FDA Class 2
·Radiology
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091033152·Baltic Denture System BDLoad BDLoad Mn7 PLSEbi...
INSTANT-VIEW Barbiturate Urine Cassette Test
FDA UDI
ALFA SCIENTIFIC DESIGNS, INC.·10796918000610·INSTANT-VIEW Barbiturate Urine Cassette Test
SOMATOM SMILE
FDA 510(k)
FDA Class 2
·Radiology
ATAC PAK DIRECT HDL REAGENT AND ATAC DIRECT HDL CALIBRATOR KITS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CUSTOM JTS NON-INVASIVE DISTAL FEMUR IMPLANT
FDA Adverse Event
Injury
·STANMORE IMPLANTS WORLDWIDE LTD.·Product code LWJ·May 15, 2015
CUSTOM JTS NON-INVASIVE DISTAL FEMUR IMPLANT
FDA Adverse Event
Malfunction
·STANMORE IMPLANTS WORLDWIDE LTD.·Product code KRO·December 24, 2014
CUSTOM JTS NON-INVASIVE DISTAL FEMUR IMPLANT
FDA Adverse Event
Malfunction
·STANMORE IMPLANTS WORLDWIDE LTD.·Product code KRO·December 23, 2014
CUSTOM PROXIMAL TIBIA JTS
FDA Adverse Event
Malfunction
·STANMORE IMPLANTS WORLDWIDE LTD·Product code KRO·December 24, 2014
KIT IMPLANTABLE SLIM TIP LEAD, 50CM
FDA Adverse Event
Injury
·ABBOTT MEDICAL·Product code PMP·October 19, 2023
CUSTOM JTS NON-INVASIVE DISTAL FEMUR IMPLANT
FDA Adverse Event
Malfunction
·STANMORE IMPLANTS WORLDWIDE LTD.·Product code KRO·December 24, 2014
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·March 1, 2013
TOTALCARE-
FDA Adverse Event
Malfunction
·HILL-ROM INC.·Product code FNL·February 28, 2011
PRECISION XTRA/OPTIUM
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE LIMITED UK·Product code NBW·April 22, 2008
JTS DRIVE UNIT FOR CUSTOM JTS NON-INVASIVE DISTAL FEMUR IMPLANT
FDA Adverse Event
Malfunction
·STANMORE IMPLANTS WORLDWIDE LTD·Product code KRO·December 24, 2014
MONOCRYL" (poliglecaprone 25) Suture REF Y936H MONOCRYL" Sutures are indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular and neurological tissues, microsurgery or ophthalmic surgery.
FDA Recall
Open, Classified
·ETHICON, INC. Calle Durango 2751 Col. Parque Industrial Americas, Juarez Juarez Mexico·Product code GAN·October 8, 2024
JTS EXTENDIBLE DISTAL FEMUR IMPLANT
FDA Adverse Event
Malfunction
·STANMORE IMPLANTS WORLDWIDE LTD·Product code KRO·December 23, 2014
DISTAL FEMUR MINIMALLY INVASIVE GROWER (MIG)
FDA Adverse Event
Malfunction
·STANMORE IMPLANTS WORLDWIDE LTD·Product code KRO·February 11, 2015
CUSTOM DISTAL FEMUR JTS REPLACEMENT IMPLANT
FDA Adverse Event
Malfunction
·STANMORE IMPLANTS WORLDWIDE LTD·Product code KRO·April 10, 2015
CUSTOM JTS NON-INVASIVE DISTAL FEMUR IMPLANT
FDA Adverse Event
Malfunction
·STANMORE IMPLANTS WORLDWIDE LTD·Product code KRO·December 19, 2014