Gramedica

FDA Filings

This page includes the latest FDA filings for Gramedica. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3004993707
FEI Number3004993707
NameGraham Medical Technologies, L.L.C. d.b.a. GraMedica
Owner & OperatorGRAMEDICA
Contact Address16137 Leone Drive --
Macomb MI 48042 US
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address16137 Leone Drive
Macomb, MI 48042 US
Establishment Type
  • Develop Specifications But Do Not Manufacture At This Facility
  • Complaint File Establishment per 21 CFR 820.198



FDA Filings

Device
Company
DeviceDate
Gramedica
osteo-WEDGE 3.0mm x 26mm Locking Bone Screw OW3.0LBS-26MM2021-10-26
Gramedica
osteo-WEDGE 3.0mm x 24mm Locking Bone Screw OW3.0LBS-24MM2021-10-26
Gramedica
osteo-WEDGE 3.0mm x 22mm Locking Bone Screw OW3.0LBS-22MM2021-10-26
Gramedica
osteo-WEDGE 3.0mm x 20mm Locking Bone Screw OW3.0LBS-20MM2021-10-26
Gramedica
osteo-WEDGE 3.0mm x 18mm Locking Bone Screw OW3.0LBS-18MM2021-10-26
Gramedica
osteo-WEDGE 3.0mm x 16mm Locking Bone Screw OW3.0LBS-16MM2021-10-26
Gramedica
osteo-WEDGE 3.0mm x 14mm Locking Bone Screw OW3.0LBS-14MM2021-10-26
Gramedica
osteo-WEDGE 3.0mm x 12mm Locking Bone Screw OW3.0LBS-12MM2021-10-26
Gramedica
osteo-WEDGE 3.0mm x 10mm Locking Bone Screw OW3.0LBS-10MM2021-10-26
Gramedica
osteo-WEDGE 3.0mm x 08mm Locking Bone Screw OW3.0LBS-08MM2021-10-26
Gramedica
osteo-WEDGE 2.5mm x 22mm Locking Bone Screw OW2.5LBS-22MM2021-10-26
Gramedica
osteo-WEDGE 2.5mm x 20mm Locking Bone Screw OW2.5LBS-20MM2021-10-26
Gramedica
osteo-WEDGE 2.5mm x 18mm Locking Bone Screw OW2.5LBS-18MM2021-10-26
Gramedica
osteo-WEDGE 2.5mm x 16mm Locking Bone Screw OW2.5LBS-16MM2021-10-26
Gramedica
osteo-WEDGE 2.5mm x 14mm Locking Bone Screw OW2.5LBS-14MM2021-10-26
Gramedica
osteo-WEDGE 2.5mm x 12mm Locking Bone Screw OW2.5LBS-12MM2021-10-26
Gramedica
osteo-WEDGE 2.5mm x 10mm Locking Bone Screw OW2.5LBS-10MM2021-10-26
Gramedica
osteo-WEDGE 2.5mm x 08mm Locking Bone Screw OW2.5LBS-08MM2021-10-26
Gramedica
osteo-WEDGE Temporary Tack 2.4mm x 12mm OW2.4TT-12MM2021-10-26
Gramedica
opti-Toe Small Straight OT-SS 2021-10-26
Gramedica
Opti-Toe-Small Angle OT-SA2021-10-26
Gramedica
HYP Sinus Tarsi Decompression Scissors HYP-ST-DS2021-10-26
Gramedica
HyProCure Instrument Set HYP-INS-TRAY2021-10-26
Gramedica
HyProCure II Trial Sizer 12 HYP II-TS-122021-10-26
Gramedica
HyProCure II Trial Sizer 11 HYP II-TS-112021-10-26
Gramedica
HyProCure II Trial Sizer 10 HYP II-TS-102021-10-26
Gramedica
HyProCure II Trial Sizer 09 HYP II-TS-092021-10-26
Gramedica
HyProCure II Trial Sizer 08 HYP II-TS-082021-10-26
Gramedica
HyProCure II Trial Sizer 07 HYP II-TS-072021-10-26
Gramedica
HyProCure II Trial Sizer 06 HYP II-TS-062021-10-26
Gramedica
HyProCure II Positioning Sleeve HYPII-PS2021-10-26
Gramedica
HyProCure II Instrument Tray-Set HYPII-INS-TRAY2021-10-26
Gramedica
HyProCure II Driver HYP II-52021-10-26
Gramedica
HyProCure II Sinus Tarsi Stent Size 12 HYP II-122021-10-26
Gramedica
HyProCure II Sinus Tarsi Stent Size 11 HYP II-112021-10-26
Gramedica
HyProCure II Sinus Tarsi Stent Size 10 HYP II-102021-10-26
Gramedica
HyProCure II Sinus Tarsi Stent Size 09 HYP II-092021-10-26
Gramedica
HyProCure II Sinus Tarsi Stent Size 08 HYP II-082021-10-26
Gramedica
HyProCure II Sinus Tarsi Stent Size 07 HYP II-072021-10-26
Gramedica
HyProCure II Sinus Tarsi Stent Size 06 HYP II-062021-10-26
Gramedica
Guide Wire HYP-GuideWires2021-10-26
Gramedica
HyProCure Size 10 HYP-102021-10-26
Gramedica
HyProCure Size 09 HYP-092021-10-26
Gramedica
HyProCure Size 08 HYP-082021-10-26
Gramedica
HyProCure Size 07 HYP-072021-10-26
Gramedica
HyProCure Size 06 HYP-062021-10-26
Gramedica
HyProCure Size 05 HYP-052021-10-26
Gramedica
HyProCure Driver HD-5-FG 2021-10-26
Gramedica
Graham Decompression Scissors, Straight GM-DS-LS2021-10-26
Gramedica
Graham Decompression Scissors, Curved Right GM-DS-LR2021-10-26
Gramedica
Graham Decompression Scissors, Curved Left GM-DS-LL2021-10-26
Gramedica
osteo-WEDGE Bone Plate 10mm GM-501-102021-10-26
Gramedica
osteo-WEDGE Bone Plate 08mm GM-501-082021-10-26
Gramedica
osteo-WEDGE Bone Plate 06mm GM-501-062021-10-26
Gramedica
osteo-WEDGE Bone Plate 04mm GM-501-042021-10-26
Gramedica
osteo-WEDGE Bone Plate 02mm GM-501-022021-10-26
Gramedica
osteo-WEDGE Bone Plate 00mm GM-501-002021-10-26
Gramedica
osteo-WEDGE Drill Guide GM-160-012021-10-26
Gramedica
osteo-WEDGE Screw Retainer Sleeve GM-150-042021-10-26
Gramedica
osteo-WEDGE Driver GM-150-032021-10-26
Gramedica
osteo-WEDGE Depth Gauge GM-150-022021-10-26
Gramedica
osteo-WEDGE Depth Gauge Sleeve GM-150-012021-10-26
Gramedica
HyProCure Sizer 10 CP15-10-FG2021-10-26
Gramedica
HyProCure Sizer 09 CP15-09-FG2021-10-26
Gramedica
HyProCure Sizer 08 CP15-08-FG2021-10-26
Gramedica
HyProCure Sizer 07 CP15-07-FG2021-10-26
Gramedica
HyProCure Sizer 06 CP15-06-FG2021-10-26
Gramedica
HyProCure Sizer 05 CP15-05-FG2021-10-26
Gramedica
osteo-WEDGE Opening Wedge Bone Locking System CarryingCase2021-10-26
Graham Medical Technologies, L.L.C. d.b.a. GraMedica [GRAMEDICA]
Osteo-Wedge II Open Wedgge bone Locking Plate System2020-01-31
Graham Medical Technologies, L.L.C. d.b.a. GraMedica [GRAMEDICA]
osteo-WEDGE Screw Retainer Sleeve2017-02-21
Graham Medical Technologies, L.L.C. d.b.a. GraMedica [GRAMEDICA]
osteo-WEDGE Driver2017-02-21
Graham Medical Technologies, L.L.C. d.b.a. GraMedica [GRAMEDICA]
osteo-WEDGE Drill Guide2017-02-21
Graham Medical Technologies, L.L.C. d.b.a. GraMedica [GRAMEDICA]
osteo-WEDGE Depth Gauge2017-02-21
Graham Medical Technologies, L.L.C. d.b.a. GraMedica [GRAMEDICA]
osteo-WEDGE Depth Gauge Sleeve2017-02-21
Graham Medical Technologies, L.L.C. d.b.a. GraMedica [GRAMEDICA]
HyProCure Sizer 102017-02-21
Graham Medical Technologies, L.L.C. d.b.a. GraMedica [GRAMEDICA]
HyProCure Sizer 092017-02-21
Graham Medical Technologies, L.L.C. d.b.a. GraMedica [GRAMEDICA]
HyProCure Sizer 082017-02-21
Graham Medical Technologies, L.L.C. d.b.a. GraMedica [GRAMEDICA]
HyProCure Sizer 072017-02-21
Graham Medical Technologies, L.L.C. d.b.a. GraMedica [GRAMEDICA]
HyProCure Sizer 062017-02-21
Graham Medical Technologies, L.L.C. d.b.a. GraMedica [GRAMEDICA]
HyProCure Sizer 052017-02-21
Graham Medical Technologies, L.L.C. d.b.a. GraMedica [GRAMEDICA]
HyProCure II Trial Sizer 122017-02-21
Graham Medical Technologies, L.L.C. d.b.a. GraMedica [GRAMEDICA]
HyProCure II Trial Sizer 102017-02-21
Graham Medical Technologies, L.L.C. d.b.a. GraMedica [GRAMEDICA]
HyProCure II Trial Sizer 092017-02-21
Graham Medical Technologies, L.L.C. d.b.a. GraMedica [GRAMEDICA]
HyProCure II Trial Sizer 082017-02-21
Graham Medical Technologies, L.L.C. d.b.a. GraMedica [GRAMEDICA]
HyProCure II Trial Sizer 072017-02-21
Graham Medical Technologies, L.L.C. d.b.a. GraMedica [GRAMEDICA]
HyProCure II Trial Sizer 062017-02-21
Graham Medical Technologies, L.L.C. d.b.a. GraMedica [GRAMEDICA]
HyProCure II Positioning Sleeve2017-02-21
Graham Medical Technologies, L.L.C. d.b.a. GraMedica [GRAMEDICA]
HyProCure II Driver2017-02-21
Graham Medical Technologies, L.L.C. d.b.a. GraMedica [GRAMEDICA]
HyProCure Driver2017-02-21
Graham Medical Technologies, L.L.C. d.b.a. GraMedica [GRAMEDICA]
Guide Wire2017-02-21
Graham Medical Technologies, L.L.C. d.b.a. GraMedica [GRAMEDICA]
HYP Sinus Tarsi Decompression Scissors2016-02-26
Graham Medical Technologies, L.L.C. d.b.a. GraMedica [GRAMEDICA]
Graham Decompression Scissors2016-02-26
Graham Medical Technologies, L.L.C. d.b.a. GraMedica [GRAMEDICA]
Opti-Toe2016-01-29
Graham Medical Technologies, L.L.C. d.b.a. GraMedica [GRAMEDICA]
HyProCure II?2015-06-17
Graham Medical Technologies, L.L.C. d.b.a. GraMedica [GRAMEDICA]
osteo-WEDGE Opening Wedge Bone Locking Plate System2011-12-15
Graham Medical Technologies, L.L.C. d.b.a. GraMedica [GRAMEDICA]
osteo-WEDGE Opening Wedge Bone Locking Plate System2011-12-15
Graham Medical Technologies, L.L.C. d.b.a. GraMedica [GRAMEDICA]
HyProCure Sinus Tarsi Stent System2007-11-02

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