42 results
·
25ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
IMMULITE 2000; 3GALLERGY SPECIFIC IGE CONTROL VERIFICATION MATERIAL (CVM), TOTAL IGE CONTROL VERIFICATION MATERIAL (CVM)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Novo Surgical Inc.
FDA UDI
NOVO SURGICAL, INC.·00842331132087·iris scissors, standard pattern, straight, 4 1/...
ELATION® MB
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807133122601·ELATION® MB Base Rx 022/UR2 8T 9A
C-MAX, C-MAX U1, C-MAX U1 160KG, C-MAX U2, C-MAX U2 160KG, S-MAX, S-MAX AVIATION, S-MAX SELLA, S-MAX SELLA 160KG
FDA 510(k)
FDA Class 2
·Physical Medicine
5000Z SYSTEM (OTC)
FDA 510(k)
FDA Class 2
·Neurology
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
M.U.S.T. PEDICLE SCREW 7X45
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MNI·January 20, 2017
CUSTOM PROXIMAL TIBIA JTS
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 24, 2014
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)
FDA Adverse Event
Injury
·ALLERGAN·Product code LTI·May 24, 2013
COLLEAGUE PRE-P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 19, 2011
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR-REDWOOD CITY·Product code MGB·August 22, 2008
PEDICLE SCREW 03.50.030 PEDICLE SCREW 7X40
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code KWP·February 3, 2020
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
MECTALIF POSTERIOR
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MAX·October 8, 2025
ZELTIQ COOLCORE (6.3)
FDA Adverse Event
Injury
·ZELTIQ AESTHETICS INC.·Product code OOK·June 19, 2014
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