1,214 results · 21ms · 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.

Novalung System

FDA 510(k)
FDA Class 2 ·Cardiovascular

OneLIF™

FDA UDI
Novapproach Spine LLC·G07001011914070·OneLIF Interbody, Small, 19 Degree, 14mm X 7mm

OneLIF™

FDA UDI
Novapproach Spine LLC·G07001111914070·Trial-OneLIF Interbody, Small, 19 Degree, 14mm ...

TRIPORT, TRIPORT+, TRIPORT15, QUADPORT

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

ALPHA HISTOPLASMA ANTIGEN EIA MODEL HAG102

FDA 510(k)
FDA Class 2 ·Microbiology

MONOPOLAR CURVED SCISSORSINSTRUMENT

FDA Adverse Event
Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·June 26, 2013

MRH TIB BP PEG EX SML

FDA Adverse Event
Malfunction ·STRYKER ORTHOPAEDICS LIMERICK·Product code KRO·July 28, 2011

LIFEPAK CR PLUS DEFIBRILLATOR

FDA Adverse Event
Malfunction ·PHYSIO-CONTROL, INC.·Product code MKJ·September 26, 2008

DGPHP RFA High-Power Single Use Grounding Pads and Cool-Tip RFA Electrode Kits (containing DGPHP RFA High-Power single use grounding pads) The product is used during ablation surgical procedures.

FDA Enforcement
Class II ·Terminated·Nellcor Puritan Bennett Inc. (dba Covidien LP)·September 5, 2012

ARTIS ZEE III CEILING

FDA Adverse Event
Malfunction ·SIEMENS HEALTHINEERS AG·Product code OWB·May 17, 2024

HEATER-COOLER SYSTEM 3T

FDA Adverse Event
Malfunction ·LIVANOVA DEUTSCHLAND GMBH·Product code DWC·January 5, 2022

HEATER-COOLER SYSTEM 3T

FDA Adverse Event
Malfunction ·LIVANOVA DEUTSCHLAND·Product code DWC·February 11, 2022

HEATER-COOLER SYSTEM 3T

FDA Adverse Event
Malfunction ·LIVANOVA DEUTSCHLAND GMBH·Product code DWC·August 19, 2020

HEATER-COOLER SYSTEM 3T

FDA Adverse Event
Malfunction ·LIVANOVA DEUTSCHLAND·Product code DWC·December 1, 2020

HEATER-COOLER SYSTEM 3T

FDA Adverse Event
Malfunction ·LIVANOVA DEUTSCHLAND·Product code DWC·October 27, 2020

HEATER-COOLER SYSTEM 3T

FDA Adverse Event
Malfunction ·LIVANOVA DEUTSCHLAND·Product code DWC·November 20, 2020

HEATER-COOLER SYSTEM 3T

FDA Adverse Event
Malfunction ·LIVANOVA DEUTSCHLAND·Product code DWC·May 7, 2021

HEATER-COOLER SYSTEM 3T

FDA Adverse Event
Malfunction ·LIVANOVA DEUTSCHLAND GMBH·Product code DWC·August 21, 2020

ARTIS ZEE III CEILING

FDA Adverse Event
Malfunction ·SIEMENS HEALTHINEERS AG·Product code OWB·December 3, 2024

HEATER-COOLER SYSTEM 3T

FDA Adverse Event
Malfunction ·LIVANOVA DEUTSCHLAND·Product code DWC·February 11, 2022