11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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