12 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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InMode System with the Morpheus8 90 Applicator
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
11mm TAP CANNULATED
FDA UDI
Osteocentric Technologies, Inc.·00810189110458·11mm TAP CANNULATED
Amplatz
FDA UDI
COOK INCORPORATED·00827002460317·Clear Amplatz Sheath With Radiopaque Stripe
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523132782·ACP, Ø4mm x 17mm, Variable Angle Screw, Self-Ta...
Cook
FDA UDI
COOK INCORPORATED·00827002574687·Clear Amplatz Sheath with Radiopaque Stripe
ABC CAUDAL AND CRANIAL EXTENSION PLATE (E-PLATE)
FDA 510(k)
FDA Class 2
·Orthopedic
TRANSONIC HCM 102 SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
MENTOR SMOOTH ROUND MODERATE PROFILE
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FWM·July 2, 2018
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·September 8, 2011
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·November 3, 2014
ENERGEN
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 22, 2013
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