17 results
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36ms
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Sources: EU EUDAMED, US FDA
CD HORIZON SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
DP-REPAIR
FDA UDI
Denplus Inc·D8451061304·DP-REPAIR-R, SPI, 11.3 kg
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496061304·BURLESQUE 70, SIZE L, MIELE, GRADUATED COMPRESS...
Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR70613041·Sprint II Brackets McLaugh/Benn/Trev. .018" 100...
OsteoMed
FDA UDI
OSTEOMED LLC·00845694017053·MFx Tag, Standard Angulated Locking Screw, 4mm
PROLITE PULSED LIGHT SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
OB-1 FETAL MONITOR
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
BD Q-SYTE CLOSED LUER ACCESS DEVICE
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FPA·March 4, 2025
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIQ·April 16, 2013
OBTRYX MESH SLING SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code FTL·June 13, 2008
VANDERLIFT 450
FDA Adverse Event
Other
·VANCARE, INC.·Product code FSA·April 5, 2011
ENCOREANYWHERE
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·February 17, 2016
PECTUS SYSTEM JANTON 12" TI PECTUS BAR 3.048CM (12") (L) TITANIUM
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code HRS·January 2, 2019
ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System 5mm x 18mm 80 cm .014" REF PMB 4-5-18-80
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
Fortify Assura, Sterile EO, Model #/ Part #: CD1257-40/100042322, 100059623; CD1257-40Q/100042341, 100059535; CD1259-40/100041914, 100042338, 100059536, 100059646, 100081567; CD1259-40Q/100041931, 100042339, 100059537, 100059620, 100059626, 100078685; CD1263-40/100042948; CD1263-40Q/100042949; CD1357-40C/100080365, 100080377, 100083441; CD1357-40Q/100080389, 100080390, 100083388; CD1359-40/100078740, 100083267, 100096839; CD1359-40C/100078500, 100078969, 100079372, 100079373, 100083442, 100083443, 100117545; CD1359-40Q/100078804, 100079155, 100079413, 100083445, 100096884; CD1359-40QC/100078603, 100079145, 100079146, 100079239, 100083405, 100083444, 100117632, 100127000, 100127065; CD1363-40C/100080349; CD1363-40Q/100080317; CD1391-40C/100080756; CD1391-40QC/100080783; CD2257-40/100042337, 100059839; CD2257-40Q/100042342, 100059842; CD2259-40/100041893, 100042308, 100059794, 100059907, 100082567; CD2259-40Q/100041894, 100042309, 100059845, 100059873, 100078610; CD2263-40/100042950; CD2263-40Q/100043201; CD2357-40C/100080404, 100080413, 100083490; CD2357-40Q/100080319, 100080412, 100083492; CD2359-40/100078750, 100083466; CD2359-40C/100078651, 100079201, 100079240, 100079442, 100083501, 100083502, 100117546; CD2359-40Q/100078841, 100079109, 100083472; CD2359-40QC/100078652, 100079156, 100079157, 100079337, 100083407, 100083465, 100117580, 100127092, 100127103; CD2363-40C/100080416; CD2363-40Q/100080407; CD2391-40C/100080784; CD2391-40QC/100080744
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018