22 results · 32ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set

FDA 510(k)
FDA Unclassified ·Unknown

BOSS Instruments

FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515068261·Weitlaner Ret, blunt prng, 2x3, 4"

BOSS Instruments

FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515027183·Weitlaner Ret, blunt prng, 2x3, 4"

FLOWTAIN & FLOWTAIN LV

FDA 510(k)
FDA Class 2 ·Dental

SPACELABS ARKON ANESTHESIA WORKSTATION

FDA 510(k)
FDA Class 2 ·Anesthesiology

I-STAT 6+ CARTRIDGE

FDA Adverse Event
Malfunction ·ABBOTT POINT OF CARE·Product code JGS·May 22, 2019

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·June 21, 2013

ECHELON*FLEX45 LONG

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·July 28, 2011

530G INSULIN PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·October 17, 2014

NAEOTOM Alpha.Prime Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS

FDA Enforcement
Class II ·Ongoing·Siemens Medical Solutions USA, Inc·February 11, 2026

IMPEDE-FX EMBOLIZATION PLUG

FDA Adverse Event
Malfunction ·SHAPE MEMORY MEDICAL INC.·Product code KRD·February 28, 2023

IMPEDE-FX EMBOLIZATION PLUG

FDA Adverse Event
Malfunction ·SHAPE MEMORY MEDICAL INC.·Product code KRD·May 7, 2024

IMPEDE-FX EMBOLIZATION PLUG

FDA Adverse Event
Malfunction ·SHAPE MEMORY MEDICAL INC.·Product code KRD·August 21, 2023

IMPEDE-FX EMBOLIZATION PLUG

FDA Adverse Event
Malfunction ·SHAPE MEMORY MEDICAL, INC.·Product code KRD·November 19, 2021

IMPEDE-FX EMBOLIZATION PLUG

FDA Adverse Event
Malfunction ·SHAPE MEMORY MEDICAL INC.·Product code KRD·February 16, 2024

IMPEDE-FX EMBOLIZATION PLUG

FDA Adverse Event
Malfunction ·SHAPE MEMORY MEDICAL INC.·Product code KRD·November 27, 2024

IMPEDE-FX EMBOLIZATION PLUG

FDA Adverse Event
Malfunction ·SHAPE MEMORY MEDICAL·Product code KRD·October 1, 2024

IMPEDE-FX EMBOLIZATION PLUG

FDA Adverse Event
Malfunction ·SHAPE MEMORY MEDICAL, INC.·Product code KRD·June 19, 2025

IMPEDE-FX EMBOLIZATION PLUG

FDA Adverse Event
Malfunction ·SHAPE MEMORY MEDICAL INC.·Product code KRD·November 9, 2021

IMPEDE-FX EMBOLIZATION PLUG

FDA Adverse Event
Malfunction ·SHAPE MEMORY MEDICAL INC.·Product code KRD·November 10, 2023