24 results
·
38ms
·
Sources: EU EUDAMED, US FDA
HAE 1
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
DBX STRIP
FDA 510(k)
FDA Class 2
·Orthopedic
Flexor Tuohy-Borst Side-Arm Introducer, Ansel Modification; Flexor Check-Flo Introducer, Ansel Modification; Flexor Check-Flo Introducers, Ansel Modification with High-Flex Dilator and Hydrophilic Coating; Flexor Check-Flo Introducer Balkin Up and Over Contralateral Design; Flexor Up and Over Balkin Contralateral Introducer; Flexor Check-Flo Introducer, Raabe Modification; Flexor Check-Flo Performer Introducer
FDA 510(k)
FDA Class 2
·Cardiovascular
FLEXOR RTPS GUIDING SHEATH
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·February 27, 2020
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·July 27, 2015
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·February 5, 2013
BELT CLIP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code LZG·July 17, 2014
FLEXOR SHUTTLE TIBIAL GUIDING SHEATH
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·September 29, 2020
FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·March 3, 2020
THAL-QUICK CHEST TUBE SET
FDA Adverse Event
Malfunction
·COOK INC·Product code GBX·January 7, 2020
FLEXOR ANSEL GUIDING SHEATH
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·March 3, 2020
UNKNOWN
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·January 10, 2022
FLEXOR ANSEL GUIDING SHEATH
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·October 22, 2019
FLEXOR RAABE GUIDING SHEATH
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·December 11, 2019
FLEXOR ANSEL GUIDING SHEATH
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·October 22, 2019
FLEXOR RAABE GUIDING SHEATH
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·November 27, 2019
FLEXOR ANSEL GUIDING SHEATH
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·November 18, 2019
UNKNOWN
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·September 15, 2020
FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·February 11, 2019
FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH
FDA Adverse Event
Injury
·COOK INC·Product code DYB·March 2, 2020