16 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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WATCHMAN TruSteer Access System (M635TU90050)
FDA 510(k)
FDA Class 2
·Cardiovascular
13mm TAP CANNULATED
FDA UDI
Osteocentric Technologies, Inc.·00810189110465·13mm TAP CANNULATED
Sapphire NC ULTRA Coronary Dilatation Catheter
FDA UDI
OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955982507·
Panama™
FDA UDI
FLOSPINE LLC·B1830802400180·Self Tapping Variable Screw, 4.0x18mm
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523132799·ACP, Ø4mm x 18mm, Variable Angle Screw, Self-Ta...
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523118076·SA Cervical Screw 4.0mm Self Tapping, 18mm
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523159239·4.0mm x 18mm Fixed Angle, Self Drilling
TSP HIP FRACTURE PLATING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE, MODELS 6410, 6411, 6412
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
KIT IMPLANTABLE SLIM TIP LEAD, 50CM
FDA Adverse Event
Injury
·ABBOTT MEDICAL·Product code PMP·July 10, 2024
BD SERO-FUGE¿ 2001 CENTRIFUGE, 1 SPEED, 115V
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code LXG·October 10, 2018
6800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·November 3, 2014
INTEGRITY SR
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWP·September 8, 2011
INCEPTA
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 22, 2013
MENTOR SMOOTH ROUND MODERATE PROFILE
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FWM·December 10, 2018
Rotarex Atherectomy System and Instructions for Use, BD SET Rotarex: S 6 F x 110 cm, REF: 80236; S 6 F x 135 cm, REF: 80237; S 8 F x 85 cm, REF: 80238; S 8 F x 110 cm, REF: 80239
FDA Enforcement
Class I
·Ongoing·Bard Peripheral Vascular Inc·March 12, 2025