10 results · 21ms · Sources: EU EUDAMED, 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