52 results
·
32ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
COMPUMEDICS SOMTE PSG RECORDING SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496072201·BE YOU STEP-UP CURVY, SIZE S-XL, NERO, OPAQUE M...
Genius Total Knee System
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215021580·
PREMICRON NONABSORBABLE PET SURGICAL SUTURE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ELECTROSTATIC HYDROPHOBIC BREATHING FILTER
FDA 510(k)
FDA Class 2
·Anesthesiology
Crescendo Meniscal Insert CR Ultracongruent 10mm Size 1
FDA UDI
AMPLITUDE SAS·03701089524599·
SPRINT QUATTRO SECURE S MRI SURESCAN
FDA Adverse Event
Injury
·MPRI·Product code LWS·February 6, 2024
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 23, 2013
ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - CORK·Product code MCX·April 28, 2011
SPRINT
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·July 10, 2008
LEAD MODEL 303
FDA Adverse Event
Malfunction
·LIVANOVA USA, INC.·Product code MUZ·November 16, 2021
LEAD MODEL 304
FDA Adverse Event
Malfunction
·LIVANOVA USA, INC.·Product code LYJ·August 29, 2025
INFINION CX
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·March 5, 2020
LEAD MODEL 300
FDA Adverse Event
Malfunction
·CYBERONICS - HOUSTON·Product code LYJ·March 31, 2025
LEAD MODEL 304
FDA Adverse Event
Malfunction
·LIVANOVA USA, INC.·Product code LYJ·August 8, 2025
LEAD MODEL 304
FDA Adverse Event
Malfunction
·LIVANOVA USA, INC.·Product code LYJ·July 13, 2021
Dual Tip Marker, Sterile Product Usage: A writing instrument intended to mark paper and plastic items around the sterile field during surgery. It has two tips. One is black for miscellaneous use. The other is for surgical skin marking.
FDA Enforcement
Class III
·Terminated·Viscot Medical LLC·April 10, 2013
CAPSUREFIX NOVUS LEAD MRI SURESCAN
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO VILLALBA·Product code DTB·November 15, 2025
LEAD MODEL UNKNOWN
FDA Adverse Event
Malfunction
·LIVANOVA USA, INC.·Product code LYJ·July 7, 2023
PREMICRON GREEN 4/0(1,5)4X45 HR13 TOM
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAT·January 29, 2020