14 results
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24ms
·
Sources: EU EUDAMED, US FDA
PHantom Trilogy
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Fixion Nailing System
FDA UDI
CARBOFIX ORTHOPEDICS LTD·07290109330938·The interlocking intramedullary nail is intende...
Fixion Nailing System
FDA UDI
CARBOFIX ORTHOPEDICS LTD·07290109330259·The nail is intended for use in the fixation of...
OsteoMed
FDA UDI
OSTEOMED LLC·00845694020398·FPS 3.5mm x 34mm Standard Screw
BD RAPID DETECTION OF SARS-COV-2 VERITOR¿
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code QKP·November 19, 2021
OsteoMed
FDA UDI
OSTEOMED LLC·00845694074506·FPS 3.5 x 34mm Screw Sterile Qty 2
HEALIX KNOTLESS ANCHOR
FDA 510(k)
FDA Class 2
·Orthopedic
SELF-COUNTERSINKING BONE SCREW
FDA 510(k)
FDA Class 2
·Orthopedic
GMK-REVISION 02.07.0310SCF FIXED TIBIAL INSERT SC SIZE 3/10MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·April 5, 2023
PARADIGM REAL -TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 25, 2014
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·August 16, 2011
VITALITY 2
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·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
BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 15, 2021