10 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Argyle Peritoneal Dialysis Cathetor and Kit, Ritus Peritoneal Dialysis Catheter Tunneling Tool Kit
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TLC Uni Knee Tibial Plate
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215077143·
InSitu Hip System
FDA UDI
NEXTSTEP ARTHROPEDIX, LLC·00816127022500·Femoral Head, 36mm, +4mm, Biolox
AAP LOQTEQ PROXIMAL LATERAL TIBIA PLATE 4.5 SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
HNC-63-INT NEUROVASCULAR ARRAY COIL
FDA 510(k)
FDA Class 2
·Radiology
HEMOSPHERE FORESIGHT MODULE
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code MUD·February 26, 2026
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 13, 2014
ACCESS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MALTA·Product code FPA·August 16, 2011
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·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