19 results
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21ms
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Sources: EU EUDAMED, US FDA
SPIDERX EMBOLIC PROTECTION DEVICE
FDA 510(k)
FDA Class 2
·Cardiovascular
Premier Amalgam Carrier
FDA UDI
PREMIER DENTAL PRODUCTS COMPANY·00348783008753·AMALGAM CARRIER (METAL) REG/LRG
Rumor
FDA UDI
Ortho Organizers, Inc.·00190707004415·Rumor .022 UL1 17T 4A 0O
PREMICRON NONABSORBABLE PET SURGICAL SUTURE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ELECTROSTATIC HYDROPHOBIC BREATHING FILTER
FDA 510(k)
FDA Class 2
·Anesthesiology
ATTUNE RP TIB BASE SZ 8 CEM
FDA Adverse Event
Injury
·DEPUY IRELAND - 9616671·Product code NJL·August 15, 2024
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·April 16, 2013
KAIROS DR
FDA Adverse Event
Malfunction
·BIOTRONIK GMBH AND CO.·Product code DXY·June 13, 2008
PROGRAMMING SOFTWARE
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·April 11, 2011
PREMICRON GREEN 4/0(1,5)4X45 HR13 TOM
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAT·January 29, 2020
PREMICRON GREEN 2/0 (3) 75CM HR26 (M)
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAW·June 28, 2019
HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE
FDA Adverse Event
Injury
·THORATEC CORPORATION·Product code DSQ·August 29, 2018
PREMICRON GREEN 2/0 (3) 30CM SKR19(M)
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAT·February 3, 2020
PREMICRON G/W 2/0(3)4X90CM2XHRC20MPF6MLP
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAT·December 30, 2019
PREMICRON GREEN 2/0 (3) 75CM HR26 (M)
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAT·December 30, 2019
PREMICRON G/W 2/0(3)4X90CM2XHRC20MPF6MLP
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAT·December 30, 2019
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