Suretek Medical

FDA Filings

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

FDA Registration(s)
Registration Number3005575604
FEI Number3005575604
NameSURETEK MEDICAL
Owner & OperatorSURETEK MEDICAL
Contact Address25-B MAPLE CREEK CIRCLE --
Greenville SC 29607 US
Official Correspondent
  • MIKE - SAMMON, PH.D.
  • x-864-2999743-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address25-B MAPLE CREEK CIRCLE
GREENVILLE, SC 29607 US
Establishment TypeReprocess Single-Use Device



FDA Filings

Device
Company
DeviceDate
SURETEK MEDICAL
Reprocessed Reflex Ultra 65 PlasmaWand w/Cable 2021-06-24
SURETEK MEDICAL
Reprocessed 2.5mm Drill Bit, 19mm 2021-06-24
SURETEK MEDICAL
Reprocessed 5.0mm Barrel Bur, 12 Flute 2021-06-24
SURETEK MEDICAL
Reprocessed 3.5mm Hooded Abrasion Bur 2021-06-24
SURETEK MEDICAL
Reprocessed 3.5mm Aggressive Cutter, 7cm 2021-06-24
SURETEK MEDICAL
Reprocessed 3.5mm VAPR Straight End Effect Electrode 2021-06-24
SURETEK MEDICAL
Reprocessed 4mm EndoScrub Sheath, 70 deg 2021-06-24
SURETEK MEDICAL
Reprocessed 4mm EndoScrub Sheath, 45 deg 2021-06-24
SURETEK MEDICAL
Reprocessed 4mm EndoScrub Sheath, 30 deg 2021-06-24
SURETEK MEDICAL
Reprocessed 2.7mm EndoScrub Sheath, 30 deg 2021-06-24
SURETEK MEDICAL
Reprocessed Endoscopic Cannulated Drill Bit, 4.5mm 2021-06-23
SURETEK MEDICAL
Reprocessed 4.0mm Hummer IV Aggressive Cutter 2021-06-23
SURETEK MEDICAL
Reprocessed 4mm EndoScrub Sheath, 70 deg 2021-06-23
SURETEK MEDICAL
Reprocessed 4mm EndoScrub Sheath, 45 deg, K Storz 2021-06-23
SURETEK MEDICAL
Reprocessed 4mm EndoScrub Sheath, 30 deg 2021-06-23
SURETEK MEDICAL
Reprocessed 4mm EndoScrub Sheath, 0 deg, w/Tubing 2021-06-23
SURETEK MEDICAL
Reprocessed 4mm EndoScrub Sheath, 0 deg 2021-06-23
SURETEK MEDICAL
Reprocessed 4mm EndoScrub Sheath, 0 deg, w/Tubing 2021-06-23
SURETEK MEDICAL
Reprocessed Sagittal Saw Blade, 90 x 18 x 1.27mm 2021-06-22
SURETEK MEDICAL
Reprocessed Endoscrub Sheath, 4mm, 0 deg 2021-06-22
SURETEK MEDICAL
Reprocessed 4.0mm RADenoid Pediatric Blade, Curved 2021-06-22
SURETEK MEDICAL
Reprocessed Round Diamond Bur, 2.0mm 2021-06-22
SURETEK MEDICAL
Reprocessed 2.9mm Quadcut Blade 2021-06-15
SURETEK MEDICAL
Reprocessed 3.0mm Quadcut Blade, Rotatable, w/ Tubing 2021-06-02
SURETEK MEDICAL
Reprocessed 3.0mm Quadcut Blade, Rotatable 2021-06-02
SURETEK MEDICAL
Reprocessed 2.0mm Inferior Turbinate Blade, Rotatable 2021-06-02
SURETEK MEDICAL
Reprocessed Oscillating Saw Blade, 19 x 1.27 x 90mm 2021-05-28
SURETEK MEDICAL
Reprocessed Sagittal Saw Blade, 90 x 19 x 1.27mm 2021-05-28
SURETEK MEDICAL
Reprocessed Sagittal Blade, 10 x 25 x 0.60mm 2021-05-28
SURETEK MEDICAL
Reprocessed Small Bone Osc Sagittal Blade, 25 x 9 x 0.38mm 2021-05-28
SURETEK MEDICAL
Reprocessed Small Bone Osc Sagittal Blade, 25 x 5.5 x 0.38mm 2021-05-28
SURETEK MEDICAL
Reprocessed Medium Narrow Blade, 18 x 5.5mm 2021-05-28
SURETEK MEDICAL
Reprocessed Small Bone Osc Sagittal Blade, 11.5 x 9.0 x 0.38mm 2021-05-28
SURETEK MEDICAL
Reprocessed Small Bone Oscillating Saw Blade, 11.5 x 5.5 x 0.38mm 2021-05-28
SURETEK MEDICAL
Reprocessed Oscillating/Sagittal Saw Blade, Thick, 25 x 5.5 x 0.56mm 2021-05-28
SURETEK MEDICAL
Reprocessed Small Bone Osc Sagittal Blade, 18 x 5.5x 0.56mm 2021-05-28
SURETEK MEDICAL
Reprocessed Small Bone Oscillating Saw Blade, 11.5 x 5.5 x 0.56mm 2021-05-28
SURETEK MEDICAL
Reprocessed Oscillating Sagittal Saw Blade, 31 x 9mm 2021-05-28
SURETEK MEDICAL
Reprocessed Oscillating Sagittal Saw Blade, 18 x 5.5 x 0.56mm 2021-05-28
SURETEK MEDICAL
Reprocessed Oscillating/Sagittal Saw Blade, Thick, 31 x 9 x 0.56mm 2021-05-28
SURETEK MEDICAL
Reprocessed Oscillating/Sagittal Saw Blade, Thick, 18.5 x 7 x 0.51mm 2021-05-28
SURETEK MEDICAL
Reprocessed Oscillating/Sagittal Saw Blade, Thick, 25 x 9 x 0.51mm 2021-05-28
SURETEK MEDICAL
Reprocessed Radial Max Sagittal Saw Blade, 19.5 x 41 x 0.38mm 2021-05-28
SURETEK MEDICAL
Reprocessed Medium Narrow Aggressive Blade, 18 x 5.5mm 2021-05-28
SURETEK MEDICAL
Reprocessed Small Bone Osc Saw Blade, 34.5 x 12 x 0.38mm 2021-05-28
SURETEK MEDICAL
Reprocessed Small Bone Oscillating Saw Blade, Thin, 30 x 9 x 0.43mm 2021-05-28
SURETEK MEDICAL
Reprocessed Small Bone Osc Sagittal Saw Blade, 18.5 x 7 x 0.17mm 2021-05-28
SURETEK MEDICAL
Reprocessed Oscillating Sagittal Saw Blade, 25 x 9 x 0.43mm 2021-05-28
SURETEK MEDICAL
Reprocessed Small Bone Oscillating Saw Blade, 39 x 13 x 0.43mm 2021-05-28
SURETEK MEDICAL
Reprocessed Small Oscillating Saw Blade, 9 x 18.5mm 2021-05-28
SURETEK MEDICAL
Reprocessed Sagittal Saw Blade, Small Bone, 25.4 x 9.5 x 0.63mm 2021-05-28
SURETEK MEDICAL
Reprocessed Small Bone Oscillating Saw Blade, 12mm x 5.5mm 2021-05-28
SURETEK MEDICAL
Reprocessed Small Bone Oscillating Saw Blade, 18.5mm x 5.5mm 2021-05-28
SURETEK MEDICAL
Reprocessed Sagittal Saw Blade, 70 x 13 x 1.27mm 2021-05-28
SURETEK MEDICAL
Reprocessed Sagittal Saw Blade, 90 x 25 x 1.27mm 2021-05-28
SURETEK MEDICAL
Reprocessed Sagittal Saw Blade, 90 x 25 x 1.27mm 2021-05-28
SURETEK MEDICAL
Reprocessed Sagittal Saw Blade, 90 x 18 x 1.19mm 2021-05-28
SURETEK MEDICAL
Reprocessed Sagittal Saw Blade, 90 x 12.5 x 1.27mm 2021-05-28
SURETEK MEDICAL
Reprocessed X-Long Wide Blade, 45mm x 13mm 2021-05-28
SURETEK MEDICAL
Reprocessed Dual Cut Sagittal Blade, 25 x 100 x 1.27 mm 2021-05-28
SURETEK MEDICAL
Reprocessed Dual Cut Sagittal Blade, 18 x 90 x 1.35mm 2021-05-28
SURETEK MEDICAL
Reprocessed Dual Cut Sagittal Blade, 18 x 90 x 1.27mm 2021-05-28
SURETEK MEDICAL
Reprocessed Dual Cut Sagittal Blade, 18 x 90 x 1.19mm 2021-05-28
SURETEK MEDICAL
Reprocessed Sagittal Saw Blade, 75 x 19 x 0.89mm 2021-05-04
SURETEK MEDICAL
Reprocessed Long Narrow Blade, 29.5 x 7 mm 2021-05-04
SURETEK MEDICAL
Reprocessed Micro Cut Dual Blade, 18.5 x 9mm 2021-05-04
SURETEK MEDICAL
Reprocessed 2.0mm Cannulated Drill Bit, QC, 150mm 2021-05-04
SURETEK MEDICAL
Reprocessed Micro Oscillating Saw Blade, 9 x 10 x 0.38mm 2021-05-04
SURETEK MEDICAL
Reprocessed Aggressive Medium Blade, 31 x 9 mm 2021-05-04
SURETEK MEDICAL
Reprocessed Aggressive Medium Blade, 25 x 9 mm 2021-05-04
SURETEK MEDICAL
Reprocessed Oscillating Saw Blade, 34.5 x 16.5mm 2021-05-04
SURETEK MEDICAL
Reprocessed Medium Narrow Blade, 18 x 5.5mm 2021-05-04
SURETEK MEDICAL
Reprocessed Long Medium Aggressive Blade, 31 x 9mm 2021-05-04
SURETEK MEDICAL
Reprocessed Micro Oscillating Sagittal Blade,18 x 5.5 mm 2021-05-04
SURETEK MEDICAL
Reprocessed Micro Oscillating Sagittal Blade, 18.5 x 7.0mm 2021-05-04
SURETEK MEDICAL
Reprocessed Micro Oscillating Sagittal Blade,18 x 5.5 mm 2021-05-04
SURETEK MEDICAL
Reprocessed Long Medium Blade, 31 x 9mm 2021-05-04
SURETEK MEDICAL
Reprocessed Large Bone Oscillating Saw Blade, 19.5 x 80 x 0.80mm 2021-05-03
SURETEK MEDICAL
Reprocessed Large Bone Knee Blade, 25 x 90 x 1.27mm 2021-05-03
SURETEK MEDICAL
Reprocessed Large Bone Knee Blade,19.0 x 105 x 1.27mm 2021-05-03
SURETEK MEDICAL
Reprocessed Large Bone Knee Blade, 19.5 x 95 x 1.27mm 2021-05-03
SURETEK MEDICAL
Reprocessed Micro Choice Sagittal Blade, Fine, 10 x 18.5mm 2021-05-03
SURETEK MEDICAL
Reprocessed Micro Sagittal Blade, Fine, 9.5 x 25.5 x 0.4mm 2021-05-03
SURETEK MEDICAL
Reprocessed Micro Oscillating Blade, Crescentic, 18 x 32 x 0.4mm 2021-05-03
SURETEK MEDICAL
Reprocessed Micro Oscillating Blade, Crescentic, 13.5 x 25.5 x 0.4mm 2021-05-03
SURETEK MEDICAL
Reprocessed Micro Choice Oscillating Blade, Fine, 10 x 35 x 0.4mm 2021-05-03
SURETEK MEDICAL
Reprocessed Micro Choice Oscillating Blade, 10 x 18.5mm 2021-05-03
SURETEK MEDICAL
Reprocessed Micro Sagittal Blade, Fine, 5.5 x 18.5 x 0.4mm 2021-05-03
SURETEK MEDICAL
Reprocessed Micro Sagittal Blade, Coarse, 9.5 x 25 x 0.6mm 2021-05-03
SURETEK MEDICAL
Reprocessed Micro Choice Sagittal Blade, Fine, 4.5 x 25.5mm 2021-05-03
SURETEK MEDICAL
Reprocessed Micro Choice Sagittal Blade, Fine, 9.5 x 25.5mm 2021-05-03
SURETEK MEDICAL
Reprocessed Micro Sagittal Blade, Coarse, 14 x 25.5 x 0.4mm 2021-05-03
SURETEK MEDICAL
Reprocessed Micro Choice Sagittal Blade, Coarse, 5.5 x 25.5mm 2021-05-03
SURETEK MEDICAL
Reprocessed Micro Choice Sagittal Blade, Coarse, 19.5 x 41mm 2021-05-03
SURETEK MEDICAL
Reprocessed Average Medium Blade, 25 x 9 mm 2021-05-03
SURETEK MEDICAL
Reprocessed Medium Medium Blade, 18.5mm x 9mm 2021-05-03
SURETEK MEDICAL
Reprocessed Sagittal Saw Blade, Wide/Thick 2021-05-03
SURETEK MEDICAL
Sagital Saw Blade, 73 x 25 x 0.89mm 2021-05-03
SURETEK MEDICAL
Reprocessed Sagittal Saw Blade, Wide/Thin, X-Short 2021-05-03
SURETEK MEDICAL
Reprocessed Heavy Duty Sagittal Blade, Straight Offset 2021-05-03
SURETEK MEDICAL
Reprocessed Sinus Cannula2013-12-15
SURETEK MEDICAL
Reprocessed Passer2013-12-15
SURETEK MEDICAL
Reprocessed Sinus Cannula2012-11-23
SURETEK MEDICAL
Reprocessed Sinuplasty Balloon Catheter2012-11-23
SURETEK MEDICAL
Reprocessed Manual ENT Instrument2012-11-23
SURETEK MEDICAL
Reprocessed Inflation Syringe2012-11-23
SURETEK MEDICAL
Reprocessed ENT Blades and Burs2008-04-20
SURETEK MEDICAL
Reprocessed Monopolar and Bipolar Arthroscopic Cutting and Coagulation Instruments2006-06-16
SURETEK MEDICAL
Reprocessed Monopolar Scissors and Dissectors2006-06-16
SURETEK MEDICAL
Reprocessed Bipolar Graspers and Cutting Instruments2006-06-16
SURETEK MEDICAL
SURETEK REPROCESSED ELE2006-06-16
SURETEK MEDICAL
Reprocessed Monopolar and Bipolar Electrosurgical Cutting and Coagulation Devices2006-06-16
SURETEK MEDICAL
SURETEK MEDICAL REPROCESSED COMPRESSION SLEEVES2006-05-17
SURETEK MEDICAL
SURETEK REPROCESSED LAPAROSCOPIC INSTRUMENTS2006-05-12
SURETEK MEDICAL
SURETEK MEDICAL REPROCESSED ARTHROSCOPIC BLADES AND BURS2006-05-10
SURETEK MEDICAL
SURETEK MEDICAL REPROCESSED ELECTROSURGICAL ELECTRODES2006-05-10
SURETEK MEDICAL
Reprocessed ENT Shavers2006-02-16
SURETEK MEDICAL
Reprocessed Arthroscopic Shavers and Burs2006-02-16
SURETEK MEDICAL
Reprocessed Orthopedic Burs and Saw Blades2006-02-16
SURETEK MEDICAL
Reprocessed Suture Grasper, Lasso, Retriever2006-01-20
SURETEK MEDICAL
Reprocessed Orthopedic Bone Tap2006-01-20
SURETEK MEDICAL
Reprocessed Surgical Drill Bit2006-01-20
SURETEK MEDICAL
Reprocessed Surgical Bur2006-01-20
SURETEK MEDICAL
Reprocessed Surgical Rasp2006-01-20
SURETEK MEDICAL
Reprocessed Surgical Reamer2006-01-20
SURETEK MEDICAL
Reprocessed Orthopedic Saw Blades2006-01-20

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