148 results
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27ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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geko W-2
FDA 510(k)
FDA Class 2
·Physical Medicine
Deltec
FDA UDI
ICU MEDICAL, INC.·10610586025556·
MJS POSTERIOR STABILIZED KNEE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ACCULIS ACCU21 PMTA MICROWAVE TISSUE ABLATION APPLICATOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SYNVISC (HYLAN G-F 20) INJECTION
FDA Adverse Event
Other
·GENZYME BIOSURGERY (RIDGEFIELD)·Product code MOZ·October 27, 2008
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·August 16, 2011
PREMIUM PLUS CEEA* 31 INSTR. S/TILT-TOP*
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY USSC PUERTO RICO·Product code GDW·July 1, 2013
Stryker PainPump ExFen, sterile, Stryker Instruments, Kalamazoo, MI; REF 525-10.
FDA Recall
Terminated
·Stryker Instruments Div. of Stryker Corporation·Product code FRN·June 16, 2009
Stryker PainPump base kit, 120 mL infusion kit, sterile, Stryker Instruments, Kalamazoo, MI; REF 500-100.
FDA Recall
Terminated
·Stryker Instruments Div. of Stryker Corporation·Product code FRN·June 16, 2009
Stryker PainPump, two site infusion set, sterile, Stryker Instruments, Kalamazoo, MI; REF 500-200.
FDA Recall
Terminated
·Stryker Instruments Div. of Stryker Corporation·Product code FRN·June 16, 2009
Stryker PainPump2, 2-site tube set with 5.0" ExFen, sterile, Stryker Instruments, Kalamazoo, MI; REF 525-200-50.
FDA Recall
Terminated
·Stryker Instruments Div. of Stryker Corporation·Product code FRN·June 16, 2009
Stryker PainPump2 ExFen 5, 5" extended fenestration catheter set for PainPump2, sterile, Stryker Instruments, Kalamazoo, MI; REF 525-500.
FDA Recall
Terminated
·Stryker Instruments Div. of Stryker Corporation·Product code FRN·June 16, 2009
Stryker PainPump2 ExFen 5, 5" catheter set for PainPump2, sterile, Stryker Instruments, Kalamazoo, MI; REF 525-501.
FDA Recall
Terminated
·Stryker Instruments Div. of Stryker Corporation·Product code FRN·June 16, 2009
Stryker PainPump catheter and split introducer needle, sterile, Stryker Instruments, Kalamazoo, MI; REF 500-23.
FDA Recall
Terminated
·Stryker Instruments Div. of Stryker Corporation·Product code FRN·June 16, 2009
Stryker ExFen 5.0" extended fenestration catheter set for PainPump, sterile, Stryker Instruments, Kalamazoo, MI; REF 500-50.
FDA Recall
Terminated
·Stryker Instruments Div. of Stryker Corporation·Product code FRN·June 16, 2009
Stryker 5.0 catheter set for PainPump2 and AutoFuser PainPump, sterile, Stryker Instruments, Kalamazoo, MI; REF 0537-005-000.
FDA Recall
Terminated
·Stryker Instruments Div. of Stryker Corporation·Product code FRN·June 16, 2009
Stryker PainPump, 270 mL infusion kit (2.08 mL/hr), sterile, Stryker Instruments, Kalamazoo, MI; REF 0501-120-000.
FDA Recall
Terminated
·Stryker Instruments Div. of Stryker Corporation·Product code FRN·June 16, 2009
Stryker PainPump ExFen, 5.0 in. dual site antimicrobial silver ExFen catheter, sterile, Stryker Instruments, Kalamazoo, MI; REF 0555-205-000.
FDA Recall
Terminated
·Stryker Instruments Div. of Stryker Corporation·Product code FRN·June 16, 2009
Stryker PainPump2, 2-site tube set with 2.5" ExFens, sterile, Stryker Instruments, Kalamazoo, MI; REF 525-200-25.
FDA Recall
Terminated
·Stryker Instruments Div. of Stryker Corporation·Product code FRN·June 16, 2009
Stryker PainPump ExFen, 10.0 in. antimicrobial silver ExFen catheter kit, sterile, Stryker Instruments, Kalamazoo, MI; REF 0555-010-000.
FDA Recall
Terminated
·Stryker Instruments Div. of Stryker Corporation·Product code FRN·June 16, 2009