13 results
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32ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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The Luminance RED Acne Device
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MARA PROBE
FDA Adverse Event
Injury
·COOPERSURGICAL, INC.·Product code MNB·June 12, 2024
NLITE SYSTEM,MODEL A00-1051
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
HARONIS ACE LAPAROSCOPIC 5MM DIAMETER SHEARS 36CM LENGTH +ADAPTIVE TISSUE TECHNOLOGY HARMONIC ACE 5MM DIAMETER SHEARS 23
FDA 510(k)
FDA Unclassified
·Unknown
5.5MM SHORT SECONDARY PORT
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY USSC PUERTO RICO INC·Product code GCJ·November 3, 2014
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·August 23, 2011
IMPAX CV REPORTING
FDA Adverse Event
Malfunction
·AGFA HEALTHCARE CORP·Product code LLZ·July 8, 2013
PATIENT TRACKER 9734887XOM NON-INVASIVE
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code HAW·January 17, 2024
NON-INVASIVE PATIENT TRACKER
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code HAW·January 18, 2024
AxiEM" Non-Invasive Patient Tracker
FDA Enforcement
Class II
·Ongoing·Medtronic Navigation, Inc.·February 8, 2023
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
FDA Enforcement
Class II
·Terminated·Cook Inc.·November 27, 2019
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
FDA Enforcement
Class II
·Terminated·Cook Inc.·November 27, 2019
ARROW Endurance Extended Dwell Peripheral Catheter System
FDA Enforcement
Class I
·Ongoing·ARROW INTERNATIONAL Inc.·June 28, 2023