10 results
·
25ms
·
Sources: EU EUDAMED, US FDA
NOVAPATH C. TRACHOMATIS DIRECT SPEC COLLECTION KIT
FDA 510(k)
FDA Class 1
·Microbiology
CoRoent
FDA UDI
Nuvasive, Inc.·00887517160904·CoRoent® XLF, 18x18x60mm 10°
Mallet
FDA UDI
KATENA PRODUCTS, INC.·00841668108604·MALLET LEAD FILLED STAINLESS
MODIFICATION TO: VIPER SPINE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Sureclear aligners
FDA 510(k)
FDA Class 2
·Dental
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 13, 2014
NOT APPLICABLE (INCIDENT OCCURRED IN BCI WAREHOUSE)
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·October 16, 2010
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·December 13, 2012
S7 STAFF ASSEMBLED 110V
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code HAW·June 2, 2020
dS Breast 7ch 3.0T
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 4, 2024