23 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ZERION ALPHA, ; ZERION BETA
FDA 510(k)
FDA Class 2
·Dental
SOAR Retractor System
FDA UDI
SPINEOLOGY INC.·M7603061804·18mm x 40mm Portal Tube
Millennia Software
FDA UDI
BRAEMAR MANUFACTURING, LLC·B146C1MA041010·The Millennia Software system is indicated for:...
OsteoMed
FDA UDI
OSTEOMED LLC·00845694017626·MFx Tag, Auto-Drive Angulated Locking Screw, 4mm
NUMED Z-5 ATRIOSEPTOSTOMY CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
CAPIOX ARTERIAL FILTER WITH X-COATING, PRODUCT CODE CX*AFO2X
FDA 510(k)
FDA Class 2
·Cardiovascular
Acapella One
FDA UDI
Choice Spine, LP·00840996151108·ACAPELLA,TRIAL,PA,NS,14X18X4
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 14, 2025
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code FTL·April 16, 2013
COR/TRI ANT STEM INSERT SHAFT
FDA Adverse Event
Malfunction
·DEPUY ORTHOPAEDICS, INC.·Product code LXH·April 1, 2011
SYNERGY PLUS+
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·June 13, 2008
VASOPRESS DIGITAL MINI PUMP
FDA Adverse Event
Malfunction
·ZIMMER SURGICAL, INC.·Product code JOW·January 6, 2020
VASOPRESS DIGITAL MINI PUMP
FDA Adverse Event
Malfunction
·COMPRESSION THERAPY CONCEPTS, INC.·Product code JOW·February 18, 2020
VASOPRESS DIGITAL MINI PUMP
FDA Adverse Event
Malfunction
·COMPRESSION THERAPY CONCEPTS, INC.·Product code JOW·September 17, 2019
VASOPRESS DIGITAL MINI PUMP
FDA Adverse Event
Malfunction
·ZIMMER SURGICAL, INC.·Product code JOW·November 19, 2019
VASOPRESS DIGITAL MINI PUMP
FDA Adverse Event
Malfunction
·ZIMMER SURGICAL, INC.·Product code JOW·November 19, 2019
VASOPRESS DIGITAL MINI PUMP
FDA Adverse Event
Malfunction
·ZIMMER SURGICAL, INC.·Product code JOW·December 10, 2019
ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery System 6mm x 21mm 80 cm .018" REF PMP 8-6-21-80
FDA Recall
Terminated
·Product code FGE·January 29, 2004
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012
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