13 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
SERFAS ENERGY SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SOAR Retractor System
FDA UDI
SPINEOLOGY INC.·M7403041810·18mm x 100mm Portal Tube
URISITE URINE COLLECTION KIT FOR MICROALBUMIN/CREATININE TESTING
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ORTHOGENESIS LPS PROXIMAL TIBIAL REPLACEMENT AND ORTHOGENESIS LPS TIBIAL BEARING
FDA 510(k)
FDA Class 2
·Orthopedic
REMSTAR AUTO M SERIES
FDA Adverse Event
Injury
·RESPIRONICS, INC.·Product code BZD·April 14, 2024
OT VERIO TEST STRIPS
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 8, 2013
TELIGEN
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 6, 2011
MERIDIAN SR
FDA Adverse Event
Injury
·CARDIAC PACEMAKERS, INC·Product code DXY·May 8, 2008
M-LNCS Y-I
FDA Adverse Event
Malfunction
·MASIMO - 40 PARKER·Product code DQA·August 12, 2017
BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code JKA·February 18, 2022
The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018
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
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