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 Sagittal Saw Blade, 90 x 19 x 1.27mm 2024-12-23
SURETEK MEDICAL
Reprocessed SutureLasso, 45 Deg, Curve Left 2024-12-23
SURETEK MEDICAL
Reprocessed Threaded Clear Cannula with Obturator, 5.5mm x 75mm 2024-12-23
SURETEK MEDICAL
Reprocessed Distal Rib Clear Cannula with Obturator, 5.5mm x 75mm 2024-12-23
SURETEK MEDICAL
Reprocessed 3.7mm Cannulated Drill Bit 2024-11-27
SURETEK MEDICAL
Reprocessed Werewolf Irrigation Tube Set 2024-11-18
SURETEK MEDICAL
Reprocessed Twist-in Cannula w/Obturator, 8.25mm x 7cm 2024-10-28
SURETEK MEDICAL
Reprocessed Mica Burr, 2mm x 20mm 2024-10-24
SURETEK MEDICAL
Reprocessed Driver Hex, Sterilemica, Screw System, 2.5mm 2024-10-24
SURETEK MEDICAL
Reprocessed Driver Hex, Sterilemica, Screw System, 2.0mm 2024-10-24
SURETEK MEDICAL
Reprocessed Drill Bit, Sterilemica Cannulated, 3.0mm 2024-10-24
SURETEK MEDICAL
Reprocessed Mica Drill Bit, 2.2mm 2024-10-24
SURETEK MEDICAL
Reprocessed Mako Bone Pins 4mm x 140mm 2024-10-02
SURETEK MEDICAL
Reprocessed Mako Bone Pins 3.2mm x 140mm 2024-10-02
SURETEK MEDICAL
Reprocessed Oscillating Sagittal Saw Blade, Thin, 25 x 5.5 x 0.38mm 2024-09-16
SURETEK MEDICAL
Reprocessed QuickPass SutureLasso, 45 Deg, Curve, Right, w/out Nitinol Wire 2024-09-16
SURETEK MEDICAL
Reprocessed QuickPass SutureLasso, 45 Deg, Curve, Left, w/out Nitinol Wire 2024-09-16
SURETEK MEDICAL
Reprocessed 1.4mm Twist Drill, WL 27mm, AO-Shaft 2024-07-31
SURETEK MEDICAL
Reprocessed 4.0mm Formula XL Tomcat Hip Cutter 2024-07-08
SURETEK MEDICAL
Reprocessed Suture Passer, Transosseous 2024-05-27
SURETEK MEDICAL
Reprocessed 2.9mm Full Radius Resector 2024-05-20
SURETEK MEDICAL
Reprocessed PassPort Button Cannula, 8mm x 4cm 2024-02-29
SURETEK MEDICAL
Reprocessed ECTRA II, Probe Knife 2024-02-29
SURETEK MEDICAL
Reprocessed MicroNeedle 3cm 2024-02-28
SURETEK MEDICAL
Reprocessed Large Tear Cross Cut Rasp, 14.0mm x 7.0mm 2024-02-20
SURETEK MEDICAL
Reprocessed Small Tear Cross Cut Rasp, 11mm x 5mm 2024-02-20
SURETEK MEDICAL
Reprocessed Carpal Tunnel Release Blade 2024-02-02
SURETEK MEDICAL
Reprocessed 4mm EndoScrub Sheath, 0 deg, w/Tubing 2024-01-04
SURETEK MEDICAL
Reprocessed Straight Micro-Needle Electrode, 3cm 2023-12-25
SURETEK MEDICAL
Reprocessed 1.7mm Cannulated Drill Bit 2023-10-02
SURETEK MEDICAL
Reprocessed 7mm Headed Reamer, Cannulated 2023-05-22
SURETEK MEDICAL
Reprocessed Arthrex 3.2mm Drill Bit, Cannulated 2023-03-27
SURETEK MEDICAL
Reprocessed Arthrex 2.9mm Drill Bit, Cannulated 2023-03-27
SURETEK MEDICAL
Reprocessed Arthrex 4.5mm Drill, Cannulated 2023-03-27
SURETEK MEDICAL
7mm Instrument Cannula, w/ Obturator 2022-09-20
SURETEK MEDICAL
Reprocessed 3.5 Stealth Full Radius Resector 2022-07-04
SURETEK MEDICAL
Reprocessed 3.5 Stealth Full Radius Resector 2022-07-04
SURETEK MEDICAL
Reprocessed 4.0mm CoolCut Dissector Blade 2022-07-04
SURETEK MEDICAL
Reprocessed 5.0mm Cool Cut Round Bur, HL 2022-07-04
SURETEK MEDICAL
Reprocessed 4.0mm Angled Aggressive Cutter Blade, 60 Deg 2022-07-04
SURETEK MEDICAL
Reprocessed 4.0mm Angled Aggressive Cutter Blade, 12 Deg 2022-07-04
SURETEK MEDICAL
Reprocessed 4.0mm Angled Aggressive Cutter Blade, 40 Deg 2022-07-04
SURETEK MEDICAL
Reprocessed 2.5mm Aggressive Cutter Blade 2022-07-04
SURETEK MEDICAL
Reprocessed 4.0mm Angled Aggressive Serrated Blade, 40 Deg 2022-07-04
SURETEK MEDICAL
Reprocessed 4.0mm Tricut Blade, Rotatable, Ext Length 13cm 2022-07-04
SURETEK MEDICAL
Reprocessed 4.0mm Tricut Angle Tip Subglottic Blade, 27cm 2022-07-04
SURETEK MEDICAL
Reprocessed 4mm Skimmer Angle Tip Blade, 27.5cm 2022-07-04
SURETEK MEDICAL
Reprocessed 4.0mm Skimmer Angle Tip Blade, 27.5cm 2022-07-04
SURETEK MEDICAL
Reprocessed 4mm Skimmer Angle Tip Blade, 22.5cm 2022-07-04
SURETEK MEDICAL
Reprocessed 4.0mm Skimmer Angle Tip Blade, 22.5cm, Rotatable 2022-07-04
SURETEK MEDICAL
Reprocessed 4.0mm Silver Bullet Blade, Rotatable 2022-07-04
SURETEK MEDICAL
Reprocessed 4.0mm Serrated Blade, Rotatable 2022-07-04
SURETEK MEDICAL
Reprocessed 3.5mm Skimmer Angle Tip Blade, 18cm 2022-07-04
SURETEK MEDICAL
Reprocessed 3.5mm Skimmer Angle Tip Blade, 27.5cm 2022-07-04
SURETEK MEDICAL
Reprocessed 3.5mm Skimmer Angle Tip Blade, 27.5cm 2022-07-04
SURETEK MEDICAL
Reprocessed 3.5mm Rad 60 Curved Blade 2022-07-04
SURETEK MEDICAL
Reprocessed 3.5mm Rad 12 Curved Blade, Rotatable 2022-07-04
SURETEK MEDICAL
Reprocessed 3.5mm Rad 12 Curved Blade 2022-07-04
SURETEK MEDICAL
Reprocessed 3.5mm Rad 40 Pediatric Blade, Curved, Key Rotatable 2022-07-04
SURETEK MEDICAL
Reprocessed 3.5mm Rad 40 Curved Blade, Rotatable 2022-07-04
SURETEK MEDICAL
Reprocessed 3.5mm Rad 40 Curved Blade 2022-07-04
SURETEK MEDICAL
Reprocessed 3.5mm Tricut Blade 2022-07-04
SURETEK MEDICAL
Reprocessed 3.5mm Serrated Blade, Rotatable 2022-07-04
SURETEK MEDICAL
Reprocessed 3.4mm Quadcut Blade 2022-07-04
SURETEK MEDICAL
Reprocessed 3.4mm Quadcut Blade 2022-07-04
SURETEK MEDICAL
Reprocessed 2.9mm Skimmer Angle Tip Blade, 13cm 2022-07-04
SURETEK MEDICAL
Reprocessed 2.9mm Skimmer Angle Tip Blade, 13cm 2022-07-04
SURETEK MEDICAL
Reprocessed 2.9mm Serrated Angle Tip Blade, 22.5cm 2022-07-04
SURETEK MEDICAL
Reprocessed 2.9mm Skimmer Angle Tip Blade, 18cm 2022-07-04
SURETEK MEDICAL
Reprocessed 2.9mm Skimmer Angle Tip Blade, 27cm 2022-07-04
SURETEK MEDICAL
Reprocessed 2.9mm Skimmer Angle Tip Blade, 22.5cm, Rotatable 2022-07-04
SURETEK MEDICAL
Reprocessed 2.9mm Silver Bullet Blade 2022-07-04
SURETEK MEDICAL
Reprocessed 2.9mm Tricut Blade, Rotatable 2022-07-04
SURETEK MEDICAL
Reprocessed 2.5mm Curved Diamond DCR Bur 2022-07-04
SURETEK MEDICAL
Reprocessed Procise EZ View Wand w/ Saline Line, Cable 2022-05-17
SURETEK MEDICAL
Reprocessed 3.2mm, Opus Magnum Spade Drill 2022-05-03
SURETEK MEDICAL
Reprocessed 5mm Hoodless Sheath, Oval Tapered 2022-05-03
SURETEK MEDICAL
Reprocessed 4.2mm Bone Cutter, HL, 19cm 2022-05-03
SURETEK MEDICAL
Reprocessed Micro Sagittal Blade, 43x10mm 2022-05-03
SURETEK MEDICAL
Reprocessed 4mm Tricut Angle Tip Subglottic Blade, 22.5cm, Rotatable 2022-05-03
SURETEK MEDICAL
Reprocessed Sagittal Blade, 18mm x 90mm x 1.27mm 2022-03-21
SURETEK MEDICAL
Reprocessed Colorado MicroNeedle, 4" Straight 2022-03-21
SURETEK MEDICAL
Reprocessed Colorado MicroNeedle, 3" Straight 2022-03-21
SURETEK MEDICAL
Reprocessed 2.9mm Serrated Blade, Rotatable 2022-03-21
SURETEK MEDICAL
Reprocessed 2.5mm Cannulated Drill Bit AO, 112mm 2022-02-17
SURETEK MEDICAL
Reprocessed 2.3mm Cannulated Drill Bit, 120mm 2022-02-17
SURETEK MEDICAL
Reprocessed 2.0mm Wire Pass Drill Bit, 50.8mm 2022-02-17
SURETEK MEDICAL
Reprocessed 3.5mm Torpedo Shaver, SJ, Small Hub 2021-12-14
SURETEK MEDICAL
Reprocessed 3.5mm Razorcut Blade 2021-12-14
SURETEK MEDICAL
Reprocessed Turbinator Wand, w/out white clip 2021-11-18
SURETEK MEDICAL
Reprocessed 1.1mm Nitinol Guide Pin 2021-11-18
SURETEK MEDICAL
Reprocessed 2.6mm Drill Bit, 122mm 2021-11-18
SURETEK MEDICAL
Reprocessed 3.5mm Cannulated Drill Bit, 160mm 2021-11-18
SURETEK MEDICAL
Reprocessed Electrocautery Dissection Micro-Needle, Straight 2021-11-18
SURETEK MEDICAL
Reprocessed Micro Oscillating Sagittal Blade, 25 x 9mm 2021-11-18
SURETEK MEDICAL
Reprocessed Large Med Aggressive Blade, 31 x 9mm 2021-11-18
SURETEK MEDICAL
Reprocessed 2.5mm Resurfacing Tool 2021-11-18
SURETEK MEDICAL
Reprocessed 4.0mm Round Resurfacing Tool 2021-11-18
SURETEK MEDICAL
Reprocessed Sagittal Saw Blade, 90 x 18 x 1.19mm 2021-11-17
SURETEK MEDICAL
Reprocessed Sagittal Saw Blade, 90 x 13 x 1.19mm 2021-11-17
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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