11 results · 21ms · Sources: EU EUDAMED, US FDA

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RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound System

FDA 510(k)
FDA Class 2 ·Radiology

UniTip High Resolution Catheter

FDA UDI
Unisensor AG·07640172970362·

VERDICT -II BAR; VERDICT -II BZO

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

ORTHOPEDIATRICS BLADE PLATE SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

VENFLON I 20GA 1.0 MM X 32MM

FDA Adverse Event
Malfunction ·BECTON DICKINSON·Product code FOZ·February 24, 2021

COCR HEAD 28/+4 'L' 12/14

FDA Adverse Event
Injury ·ZIMMER GMBH·Product code MEH·January 26, 2026

NEXTAR SPINE

FDA Adverse Event
Malfunction ·MEDACTA INTERNATIONAL SA·Product code OLO·March 28, 2024

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 12, 2011

SECUR-FIT HA PSL CUP/CLUSTR SHELL 48MM

FDA Adverse Event
Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code MEH·October 29, 2014

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·July 8, 2013

ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017  S 2000 system 10441730  S 3000 system 10441701  S 1000 system 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.·August 5, 2015