255 results
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29ms
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Sources: EU EUDAMED, US FDA
Lenses, Soft Contact, Daily Wear
FDA Pre-Market Approval
FDA Class 2
·SCANLENS (SCAFILCON A CONTACT LENS)
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·SCANLENS (SCAFILCON A CONTACT LENS)
Pro Advantage
FDA UDI
NATIONAL DISTRIBUTION & CONTRACTING, INC.·M220P8500932·Pro Advantage Electrode Foam 2 3/4 Round 4PK
PRO ADVANTAGE
FDA UDI
NATIONAL DISTRIBUTION & CONTRACTING, INC.·M220P7500333·PRO ADVANTAGE GOWN EXAM TPT 30X42 BLUE 50/CS
KOTEX MAXI PADS
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
Reprocessed Microline Scissor Tips intended to be used with a reusable hand piece and designed for minimally invasive and open surgical procedures to facilitate cutting, preparation, mobilization, and coagulation of tissue. Model #'s MIC3112, MIC3122, MIC3132, MIC3142, MIC3152, MIC3162.
FDA Enforcement
Class II
·Terminated·STERILMED, INC.·June 8, 2016
MICRA
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code PNJ·December 30, 2019
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·June 4, 2014
COLONRING/COMPRESSION ANASTOMOSIS RING (CAR27)
FDA Adverse Event
Injury
·NOVOGI LTD.·Product code FZP·November 26, 2012
SECURE II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER CORP. MEDICAL DIVISION·Product code FNL·September 27, 2010
MICRA
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code PNJ·December 27, 2019
Implant, Dermal, For Aesthetic Use
FDA Pre-Market Approval
FDA Class 3
·HYDRELLE
Leadless Pacemaker
FDA Pre-Market Approval
FDA Class 3
·MEDTRONIC MICRA TRANSCATHETER PACEMAKER SYSTEM
Leadless Pacemaker
FDA Pre-Market Approval
FDA Class 3
·Micra
Implant, Dermal, For Aesthetic Use
FDA Pre-Market Approval
FDA Class 3
·HYDRELLE
Leadless Pacemaker
FDA Pre-Market Approval
FDA Class 3
·MEDTRONIC MICRA TRANSCATHETER PACEMAKER SYSTEM
Leadless Pacemaker
FDA Pre-Market Approval
FDA Class 3
·Micra VR TPS
Leadless Pacemaker
FDA Pre-Market Approval
FDA Class 3
·Micra AV TPS; Micra TPS; Micra VR TPS
Leadless Pacemaker
FDA Pre-Market Approval
FDA Class 3
·Micra TPS
Leadless Pacemaker
FDA Pre-Market Approval
FDA Class 3
·Micra TPS