12 results
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27ms
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Sources: EU EUDAMED, US FDA
TRANSPORT INCUBATOR
FDA 510(k)
FDA Class 2
·General Hospital
VASERlipo System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
FDA 510(k)
FDA Class 1
·General Hospital
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code LWS·May 5, 2014
KAPPA 900 DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code DXY·October 15, 2012
SENTINOL SELF-EXPANDING NITINOL VASCULAR STENT SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code FGE·August 10, 2010
VASERLIPO SYSTEM
FDA Adverse Event
Injury
·SOLTA MEDICAL, INC·Product code QPB·January 5, 2023
VASERLIPO SYSTEM
FDA Adverse Event
Injury
·SOLTA MEDICAL, INC·Product code QPB·January 10, 2023
VASERLIPO SYSTEM
FDA Adverse Event
Injury
·SOLTA MEDICAL, INC·Product code QPB·October 21, 2022
ICU Medical 14" (36 cm) Appx 3.6 ml, Bifuse Transfer Set w/Rotating Luer, REF: 14237-28 The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).
FDA Recall
Completed
·ICU Medical, Inc.·Product code FMG·August 20, 2018
PROPONENT DR SL (Model L201)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Number 314-02-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024