12 results
·
37ms
·
Sources: EU EUDAMED, US FDA
Bard RiteCath Intermittent Urinary Catheter
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
WHITACRE
FDA Adverse Event
Malfunction
·BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.·Product code BSP·January 27, 2026
AMPLIFE DIGITAL CLINICAL THERMOMETER
FDA 510(k)
FDA Class 2
·General Hospital
ORTHO MTA (MINERAL TRIOXIDE AGGREGATE)
FDA 510(k)
FDA Class 2
·Dental
LINEAR? ST
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·July 18, 2025
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 5, 2025
SENSIA SR
FDA Adverse Event
Death
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NVZ·June 3, 2013
JUVEDERM VOLUMA XC 27G 2 X 1ML
FDA Adverse Event
Injury
·ALLERGAN·Product code LMH·September 30, 2014
LEVEL 1 DISPOSABLE NORMOTHERMIC IV ADMINISTRATION SETS
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.,·Product code KZL·June 20, 2011
MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025
MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025
Surgical Table Cushion (HybriGel Pads) HybrGel Pads are an optional accessory to the Operon Surgical Table. The pads may be attached to the base section with a Velcro fastener. The HybriGel pad shapes and variants can differ depending on the scope of the delivery.
FDA Enforcement
Class II
·Terminated·Berchtold Corp.·June 15, 2016