14 results · 30ms · 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.

TERASON USMART3200 AND BENQ UP200ULTRASOUND SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

MSI Precision Specialty Instruments

FDA UDI
Med Saver, Inc.·00194613017774·K-Wire, Double Ended, Trocar Point, Diameter Si...

PORTA SOLDER 1090 W

FDA 510(k)
FDA Class 2 ·Dental

POLYTEL(R) APT MODEL: PWA-08-01

FDA 510(k)
FDA Class 2 ·Cardiovascular

SYRINGE 1.0ML 29GA 1/2IN BLS 500 AU

FDA Adverse Event
Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·March 25, 2020

BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FOZ·February 7, 2022

DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·November 16, 2018

FEMORAL COMPONENT

FDA Adverse Event
Injury ·SMITH & NEPHEW, INC.·Product code JDH·May 31, 2013

PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·June 27, 2011

ACCU-CHEK COMFORT CURVE TEST STRIPS

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·August 28, 2008

SYRINGE 1.0ML 29GA 1/2IN BLS 500 AU

FDA Adverse Event
Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·March 23, 2020

CORAIL2 STD SIZE 12

FDA Adverse Event
Malfunction ·DEPUY IRELAND - 9616671·Product code LZO·May 30, 2024

TrueBeam Radiotherapy Delivery System and EDGE" Radiotherapy Delivery System, K140528. The TrueBeam and Edge Systems are intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation therapy is indicated for adults and pediatric patients.

FDA Recall
Terminated ·Vision RT Ltd Dove House, Arcadia Avenue London United Kingdom·Product code IYE·June 30, 2016

TrueBeam¿ Radiotherapy Delivery System and EDGE" Radiotherapy Delivery System, K140528. The TrueBeam and Edge Systems are intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation therapy is indicated for adults and pediatric patients.

FDA Enforcement
Class II ·Terminated·Vision RT Ltd·August 31, 2016