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FDA 510(k) Applications Submitted by NANCY MACDONALD
FDA 510(k) Number
Submission Date
Device Name
Applicant
K980717
02/24/1998
UROMED SLING KIT
UROMED CORP.
K991237
04/12/1999
XPLAN-2 WITH HEAD AND NECK LOCALIZER, MODEL HNL
RADIONICS, INC.
K971992
05/29/1997
UROMED ALTERNATIVE BLADDER CONTROL CONTINENCE DEVICE(ABCPN-0026)
UROMED CORP.
K181902
07/16/2018
Codman Certas Plus Electronic Tool Kit
Integra LifeSciences Corp.
K182265
08/21/2018
CodMan Certas Plus Programmable Valve
Integra LifeSciences Corp.
K993594
10/25/1999
CONFORMAX MMLC VR1
RADIONICS, INC.
K990071
01/11/1999
IMAGEFUSION 2.0
RADIONICS, INC.
K120992
04/02/2012
METS SMILES TOTAL KNEE REPLACEMENT
STANMORE IMPLANTS WORLDWIDE LTD
K121029
04/05/2012
METS MODULAR DISTAL FEMUR
STANMORE IMPLANTS WORLDWIDE LTD
K121055
04/06/2012
METS MODULAR TOTAL FEMUR
STANMORE IMPLANTS WORLDWIDE LTD.
K121056
04/06/2012
METS MODULAR PROXIMAL FEMUR
STANMORE IMPLANTS WORLDWIDE LTD.
K991523
05/03/1999
TLC PEDIATRIC FRAME, MODEL TLC-SYS
RADIONICS, INC.
K001700
06/05/2000
XPLAN 2.1
RADIONICS, INC.
K002773
09/06/2000
NEUROMAP WITH NEURO 100
RADIONICS, INC.
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