14 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
FIREBIRD SI Fusion System
FDA 510(k)
FDA Class 2
·Orthopedic
EdgePRO™
FDA UDI
US ENDODONTICS, LLC·00818365026647·EdgePRO™ Tinted Multi-Wavelength Protective Fil...
NA
FDA UDI
Synthes GmbH·10886982141446·1.3MM CORTEX SCREW SELF-TAPPING 16MM
MACROPOREMX MANDIBULAR FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Dental
Crosstex VH2O2 Chemical Indicators
FDA 510(k)
FDA Class 2
·General Hospital
ENRHYTHM DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code DXY·August 11, 2011
530G INSULIN PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO·Product code OZO·September 17, 2014
OBTRYX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 1, 2013
OPTETRAK KNEE SYSTEM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·July 23, 2024
SPECIFIC DEVICE NOT REPORTED
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·July 23, 2024
PS TIBIAL INSERTS SZ 2, 11MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·February 17, 2023
PS TIBIAL INSERTS SZ 2, 13MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·February 17, 2023
18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer 10041227 & 10789400 S1000 10441701 S2000 10041461 S2000 (Refurb) - 10440017 S3000 10441730 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·May 3, 2017
EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·February 3, 2021