40 results
·
24ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
ACCESS STFR, ACCESS STFR CALIBRATORS, AND ACCESS STFR QC WITH MODELS, A32493, A32494, AND A32495
FDA 510(k)
FDA Class 2
·Immunology
Conformis Hip System
FDA UDI
Conformis, Inc.·00810933031046·TRIAL HEAD, 36MM, SH
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810014606705·GETINGE / SHAMPAINE 1501 RADI-OP 3" DELUXE
NA
FDA UDI
STRYKER CORPORATION·07613327058635·Cannula, Automatic Valve, Stopcock, without Trocar
HEARTSTREAM XL DEFIBIBRILLATOR/MONITOR, MODEL M4735A, HEARTSTREAM XLT DEFIBRILLATOR/MONITOR.MODEL M2500B
FDA 510(k)
FDA Class 3
·Cardiovascular
ROD TO ROD CROSS BRACES
FDA 510(k)
FDA Class 2
·Orthopedic
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·October 6, 2011
WAVEWRITER ALPHA 16
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·February 2, 2026
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·November 28, 2011
INFINION CX
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·November 16, 2024
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 29, 2012
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·April 3, 2012
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code OYC·December 15, 2016
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 26, 2013
OMNISPAN MENISCAL FASTENER, W/12 DEGREE NEEDLE
FDA Adverse Event
Injury
·DEPUY MITEK·Product code MBI·April 25, 2011
MAGIC TORQUE GUIDEWIRE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC·Product code DQX·July 22, 2008
INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·March 27, 2018
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·December 24, 2017
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·January 1, 2017
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·October 28, 2011