13 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
INFUSOMAT SPACE
FDA Adverse Event
Malfunction
·B. BRAUN MELSUNGEN AG·Product code FRN·January 19, 2016
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·00304040067710·MOLAR BAND LR 1ST 33 (2)
TRIO LX SMALL CONNECTOR
FDA Adverse Event
Malfunction
·STRYKER SPINE BORDEAUX·Product code MNI·March 23, 2011
PARIETEX COMPOSITE (PCO) MESH
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
TRANSFER COMPANION HR 3000 MANUAL WHEELCHAIR
FDA 510(k)
FDA Class 1
·Physical Medicine
UNKNOWN EEA
FDA Adverse Event
Death
·US SURGICAL PUERTO RICO·Product code GDW·March 23, 2022
KINETRA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·April 17, 2013
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·June 18, 2008
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·April 12, 2011
Smiths Medical CADD Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper included. 100mL, Product Code 21-7302-24
FDA Enforcement
Class II
·Ongoing·ICU Medical Inc.·September 10, 2025
Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015