13 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Single Use Retrieval Nitinol Basket V
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
OsteoMed
FDA UDI
OSTEOMED LLC·00842528103128·7.0 x 110mm Cann Hdless Screw, 32mm Thd
OsteoMed
FDA UDI
OSTEOMED LLC·00842528107485·7.0 x 110mm Hdls Screw 32Thd Sterile 2Pk
IMPEDIMED - EXTRACELLULAR FLUID ANALYZER MODEL: L-DEX U400
FDA 510(k)
FDA Class 2
·Cardiovascular
CORDLESS PORTABLE DENTAL X-RAY SYSTEM, MODEL ADX4000
FDA 510(k)
FDA Class 2
·Dental
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 2, 2025
CAREFUSION
FDA Adverse Event
Malfunction
·CAREFUSION·Product code CBK·May 23, 2013
TOTALCARE
FDA Adverse Event
Malfunction
·HILL-ROM INC.·Product code FNL·June 22, 2011
ENCORE KNEE INSTRUMENT
FDA Adverse Event
Malfunction
·ENCORE MEDICAL, L.P.·Product code HWB·September 15, 2008
PENUMBRA COIL 400
FDA Adverse Event
Injury
·PENUMBRA, INC.·Product code HCG·November 29, 2016
STABLE BASE
FDA Adverse Event
Injury
·LEONHARD LANG GMBH·Product code DRX·December 18, 2018
MICROVASCULAR PLUG
FDA Adverse Event
Injury
·MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR·Product code KRD·August 27, 2018
CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024