24 results · 39ms · Sources: EU EUDAMED, US FDA

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Advance 14LP Low Profile PTA Balloon Dilatation Catheter

FDA 510(k)
FDA Class 2 ·Cardiovascular

ADVANCE 14 LP LOW PROFILE BALLOON CATHETER

FDA Adverse Event
Malfunction ·COOK INC·Product code LIT·September 12, 2019

ADVANCE 14 LP LOW PROFILE BALLOON CATHETER

FDA Adverse Event
Malfunction ·COOK INC·Product code LIT·January 2, 2019

ADVANCE 14 LP LOW PROFILE BALLOON CATHETER

FDA Adverse Event
Malfunction ·COOK INC·Product code LIT·February 12, 2019

ADVANCE 14 LP LOW PROFILE BALLOON CATHETER

FDA Adverse Event
Malfunction ·COOK INC·Product code LIT·March 8, 2019

ADVANCE 14 LP LOW PROFILE BALLOON CATHETER

FDA Adverse Event
Malfunction ·COOK INC·Product code LIT·February 18, 2019

ADVANCE 14 LP LOW PROFILE BALLOON CATHETER

FDA Adverse Event
Malfunction ·COOK INC·Product code LIT·January 3, 2020

ADVANCE 14 LP LOW PROFILE BALLOON CATHETER

FDA Adverse Event
Malfunction ·COOK INC·Product code LIT·January 2, 2020

ADVANCE 14 LP LOW PROFILE BALLOON CATHETER

FDA Adverse Event
Malfunction ·COOK INC·Product code LIT·July 26, 2019

ADVANCE 14 LP LOW PROFILE BALLOON CATHETER

FDA Adverse Event
Malfunction ·COOK INC·Product code LIT·November 20, 2019

ADVANCE 14 LP LOW PROFILE BALLOON CATHETER

FDA Adverse Event
Malfunction ·COOK INC·Product code LIT·November 8, 2019

ADVANCE 14 LP LOW PROFILE BALLOON CATHETER

FDA Adverse Event
Malfunction ·COOK INC·Product code LIT·July 12, 2024

ENVITEC OXIPEN PULSE OXIMETER AND ACCESSORIES

FDA 510(k)
FDA Class 2 ·Cardiovascular

OTOMAG BONE CONDUCTION HEARING SYSTEM

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

SLEEPSTYLE AUTO

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BZD·January 2, 2025

SLEEPSTYLE AUTO

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BZD·February 18, 2025

T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code OZO·June 20, 2019

SLEEPSTYLE AUTO

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BZD·September 12, 2024

SLEEPSTYLE AUTO

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BZD·November 14, 2024

EEA 28MM SINGLE-USER STAPLER

FDA Adverse Event
Injury ·COVIDIEN, FORMERLY USSC·Product code GDW·June 7, 2013