12 results
·
28ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Micro-current facial cold and hot service (model: TPML-100)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Vitique
FDA UDI
DMG Chemisch-Pharmazeutische Fabrik GmbH·EDMG2130391·Highly esthetic permanent composite luting ceme...
SMITH & NEPHEW RADIOPAQUE TRIAL NECKS
FDA 510(k)
FDA Class 2
·Orthopedic
INION CPS 2.0 ORTHOGNATHIC PLATE
FDA 510(k)
FDA Class 2
·Dental
INRATIO
FDA Adverse Event
Malfunction
·BIOSITE INCORPORATED·Product code GJS·June 22, 2009
INRATIO
FDA Adverse Event
Malfunction
·BIOSITE INCORPORATED·Product code JPA·June 24, 2009
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 16, 2011
LOTUS INTRODUCER SET
FDA Adverse Event
Injury
·CREGANNA-TACTX MEDICAL·Product code DYB·October 24, 2014
ENDOTAK RELIANCE
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NVY·July 9, 2013
MAGNETOM Cima.X (DE). Model Number: 11647158.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025
LAPIPLASTY 4.0MM FULLY THREADED SCREW
FDA Adverse Event
Injury
·TREACE MEDICAL CONCEPTS, INC.·Product code HWC·March 14, 2025
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