14 results · 24ms · 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.

CareTaker Continuous Non-Invasive Blood Pressure Monitor, CareTaker Wireless VItal Signs Monitor

FDA 510(k)
FDA Class 2 ·Cardiovascular

Bernafon

FDA UDI
Bernafon AG·05711584055403·SA5 ITED, WL L BE SAPHIRA 5

ProLift Trial

FDA UDI
Life Spine, Inc.·00190837088316·

JOURNEY CR KNEE SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

INTRAVASCULAR ADMINISTRATION SET AND EXTENSION SET

FDA 510(k)
FDA Class 2 ·General Hospital

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·June 26, 2024

530G INSULIN PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·October 8, 2014

ATTAIN ABILITY

FDA Adverse Event
Injury ·MPRI·Product code OJX·June 7, 2013

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·June 24, 2011

BD MAXPLUS¿ PRESSURE RATED EXTENSION SET WITH REMOVABLE NEEDLELESS CONNECTOR

FDA Adverse Event
Malfunction ·BECTON DICKINSON·Product code FPA·January 3, 2023

BD MAXPLUS¿ PRESSURE RATED EXTENSION SET WITH REMOVABLE NEEDLELESS CONNECTOR

FDA Adverse Event
Malfunction ·BECTON DICKINSON·Product code FPA·January 3, 2023

AES-50SP PARADIGM EDGE HIP PROBE, 50 DEGREE

FDA Adverse Event
Injury ·CONMED UTICA·Product code GEI·May 18, 2023

AES-50SP PARADIGM EDGE HIP PROBE, 50 DEGREE

FDA Adverse Event
Malfunction ·CONMED UTICA·Product code GEI·May 25, 2023

Medical Linear Accelerator

FDA Enforcement
Class II ·Terminated·Elekta, Inc.·September 14, 2016