17 results · 27ms · Sources: EU EUDAMED, US FDA

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VINTAGE ZR

FDA 510(k)
FDA Class 2 ·Dental

BD INSYTE AUTOGUARD -P AND BD INSYTE AUTOGUARD -P WINGED IV CATHETERS

FDA 510(k)
FDA Class 2 ·General Hospital

MULTIFUNCTION ENDOSCOPIC INSTRUMENT

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

HUDSON ET TUBE, SHER-I-BRONCH, RS, 35 FR

FDA Adverse Event
Malfunction ·Product code CBI·June 7, 2021

BD INTIMA-II Y 22GAX1.00IN PRN/EC SLM

FDA Adverse Event
Malfunction ·BD SUZHOU (MDS)·Product code FOZ·September 23, 2024

ACCU-CHEK SPIRIT COMBO

FDA Adverse Event
Malfunction ·ROCHE DIABETES CARE AG·Product code LZG·April 11, 2013

CVC KIT: 2-LUMEN 5 FR X 55 CM

FDA Adverse Event
Malfunction ·ARROW INTERNATIONAL INC·Product code LJS·March 2, 2011

ACCU-CHEK COMFORT CURVE TEST STRIPS

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·May 21, 2008

BD INTIMA-II Y 22GAX1.00IN PRN/EC SLM

FDA Adverse Event
Malfunction ·BD SUZHOU (MDS)·Product code FOZ·November 27, 2024

BD INTIMA-II Y 22GAX1.00IN PRN/EC SLM

FDA Adverse Event
Malfunction ·BD SUZHOU (MDS)·Product code FOZ·November 12, 2024

BD INTIMA-II Y 22GAX1.00IN PRN/EC SLM

FDA Adverse Event
Malfunction ·BD SUZHOU (MDS)·Product code FOZ·October 2, 2024

TI LOW PROFILE NEURO SCREW SELF-DRILLING 4MM

FDA Adverse Event
Malfunction ·SYNTHES GMBH·Product code JEY·October 12, 2023

BD INTIMA-II Y 22GAX1.00IN PRN/EC SLM

FDA Adverse Event
Malfunction ·BD SUZHOU (MDS)·Product code FOZ·September 23, 2024

TI LOW PROFILE NEURO SCREW SELF-DRILLING 4MM

FDA Adverse Event
Malfunction ·SYNTHES GMBH·Product code JEY·August 8, 2023

TI LOW PROFILE NEURO SCREW SELF-DRILLING 4MM

FDA Adverse Event
Malfunction ·SYNTHES GMBH·Product code JEY·October 26, 2023

BD INTIMA-II Y 22GAX1.00IN PRN/EC SLM

FDA Adverse Event
Malfunction ·BD SUZHOU (MDS)·Product code FOZ·December 2, 2024

Anthem Model Numbers: PM3210, PM3212; Allure/Relieve Model Numbers: PM3222, PM3242, PM3262, PM3542, PM3224, PM3244 Implantation of a single-chamber pulse generator, dual-chamber pulse generator, or CRT-P is indicated in one or more of the following permanent conditions: Syncope, Presyncope, Fatigue, Disorientation, Or any combination of those symptoms. Implantation of a CRT-P is indicated for: Maintaining synchrony of the left and right ventricles in patients who have undergone an AV nodal ablation for chronic atrial fibrillation and have NYHA Class II or III heart failure. The reduction of the symptoms of moderate to severe heart failure (NYHA Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction d35% and a prolonged QRS duration

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·October 25, 2017