21 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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GI MONITOR AND GI MONITOR CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 387687, 387688
FDA 510(k)
FDA Class 2
·Immunology
Baltic Denture System BD Load
FDA UDI
Merz Dental GmbH·D7091033038·Baltic Denture System BDLoad Mn6 PLSEbim6DFm C4...
INSTANT-VIEW Methamphetamine (500) Urine Dip-Strip Test
FDA UDI
ALFA SCIENTIFIC DESIGNS, INC.·10796918000375·INSTANT-VIEW Methamphetamine (500) Urine Dip-St...
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0330080·Rocker, Hinged, Locking
AGILENT COMPONENT MONITORING SYSTEM, AGILENT V24/26, AGILENT BIS MODULE, MODEL M1175A/76A/77A,REV.L,M1205A,REV.L,M1034A
FDA 510(k)
FDA Class 2
·Neurology
SAFE MAXI HOLLOW FIBER OXYGENATOR, MODEL 016010
FDA 510(k)
FDA Class 2
·Cardiovascular
SEE H10
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code NBC·April 18, 2013
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 3, 2013
RX ACCULINK CAROTID STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIM·March 29, 2011
FLO-GARD 6201 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD·Product code FRN·April 22, 2008
BD PHOENIX PANEL NMIC-306
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code LON·June 17, 2022
BD PHOENIX PANEL NMIC-306
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code LON·June 17, 2022
BD PHOENIX PANEL NMIC-306
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code LON·June 17, 2022
BD PHOENIX PANEL NMIC-306
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code LON·June 17, 2022
BD PHOENIX PANEL NMIC-306
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code LON·June 17, 2022
BD PHOENIX PANEL NMIC-306
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code LON·June 17, 2022
BD PHOENIX PANEL NMIC-306
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code LON·June 17, 2022
BD PHOENIX PANEL NMIC-306
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code LON·June 17, 2022
POLYMOBIL PLUS
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE GMBH·Product code IZL·July 27, 2023
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