10 results
·
27ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Fibrillar Collagen Wound Dressing
FDA 510(k)
FDA Unclassified
·Unknown
iTero Lumina Mobile upgrade from Element Plus
FDA UDI
Align Technology, Inc.·00816063021445·Upgrade kit for existing iTero users who upgrad...
CD-Chex Plus
FDA UDI
STRECK, INC.·00844509000112·A positive procedural control for monitoring im...
NATURAL EXTENSIONS
FDA UDI
BENCO DENTAL SUPPLY CO.·00366975030740·
ARTHREX PEC REPAIR BUTTON, ARTHREX LARGE PEC BUTTON, ARTHREX BICEPS BUTTON, ARTHREX PROXIMAL BICEPS BUTTON
FDA 510(k)
FDA Class 2
·Orthopedic
GUIDESHOT OPTION, SCENARIA WHOLE-BODY X-RAY CT SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
RESERVOIR 1.8ML
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·October 25, 2014
ASR UNI FEMORAL IMPL SIZE 47
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·August 12, 2011
MINICAP
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·July 9, 2013
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