Aspen Surgical

FDA Filings

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

FDA Registration(s)
Registration Number1836161
FEI Number3002750084
NameASPEN SURGICAL PRODUCTS, INC.
Owner & OperatorAspen Surgical
Contact Address6945 Southbelt Drive S.E.
Caledonia MI 49316 US
Official Correspondent
  • Michelle Pulaski
  • x-616-6987100-x
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address6945 SOUTHBELT DR. S.E.
Caledonia, MI 49316 US
Establishment Type
  • Repack or Relabel Medical Device
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Medical Device



Registration Number2649798
FEI Number2649798
NameAspen Surgical Puerto Rico Corp.
Owner & OperatorAspen Surgical
Contact Address6945 Southbelt Drive S.E.
Caledonia MI 49316 US
Official Correspondent
  • Michelle Pulaski
  • x-616-6987100-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressRD. 183, KM. 20.3
LAS PIEDRAS, PR 00771 US
Establishment TypeManufacture Medical Device



FDA Filings

Device
Company
DeviceDate
ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]
ErgoSupport Step Stool2020-01-24
ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]
Universal Head Restraint2020-01-24
ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]
Thigh Holder Pad2020-01-24
ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]
TLC Distraction Pad Set2020-01-24
ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]
Smoot Ankle Distraction Foot Strap2020-01-24
ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]
Sedona Arm Cradle2020-01-24
ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]
Seattle Brachy Bed2020-01-24
ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]
Racine Pelvic Positioning Pad2020-01-24
ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]
Prone Face Pillow2020-01-24
ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]
Pink XL Hermanator Knee Pad2020-01-24
ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]
Perineal Post Cover2020-01-24
ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]
Patient Care Boot Insert2020-01-24
ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]
Parent Post Pad2020-01-24
ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]
Norton Arm Kit2020-01-24
ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]
Montreal Hip Positioner2020-01-24
ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]
Marco Shoulder Stabilization Kit2020-01-24
ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]
MD Traction Rope2020-01-24
ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]
Lindy Boot Liner2020-01-24
ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]
Lewiston Hip Kit2020-01-24
ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]
Leg Comfort Pad2020-01-24
ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]
Lateral Positioner Pad Set2020-01-24
ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]
Jessie Arm Suspension Kit2020-01-24
ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]
JEMS Triangle Pad2020-01-24
ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]
Indy Beach Chair Face Mask2020-01-24
ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]
Hermanator Knee Positioning Pad2020-01-24
ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]
Extended Elbow Pad2020-01-24
ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]
Erin Mask2020-01-24
ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]
Erin Mask Replacement Strap2020-01-24
ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]
Dr. Don's Arm Canoe2020-01-24
ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]
Dr. Don's Arm Canoe - V2020-01-24
ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]
Dr Don's Arm Suspension Kit2020-01-24
ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]
Dr Don's Arm Suspension Kit Northern2020-01-24
ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]
Dr Don's Arm Suspension Kit Montana2020-01-24
ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]
Carson Perineal Post Pad2020-01-24
ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]
Bethesda Face Mask2020-01-24
ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]
Berkette Beach Chair Limb Positioner2020-01-24
ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]
Beach Chair Head and Chin Straps2020-01-24
ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]
Aspen Needle Counter2019-10-14
ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]
Aspen Needle Container2019-10-14
ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]
Aspen Needle Counter2019-10-14
ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]
Aspen Needle Container2019-10-14
ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]
Laparoscope, Dr. Fog solution2019-10-14
ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]
Dr. Fog anti-fog2019-10-14
ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]
kittner2019-10-14
ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]
Sterion Wound Closure2019-10-14
ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]
Cautery Tip Cleaner2019-10-14
ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]
Light Handle Covers2019-10-14
ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]
Adaptors2019-10-14
ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]
ALC Plus Disposable Light Handle Cover2019-10-14
ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]
transparent dressing2019-10-14
ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]
SafeClean brushes2019-10-14
ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]
Tube Holder with Removable Strap2019-10-14
ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]
Sterion Tip Protectors2019-10-14
ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]
Sterion Locking Tags2019-10-14
ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]
Sterion Labels2019-10-14
ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]
Non-Sterile Medication Labels2019-10-14
ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]
ColorTrack identification tags2019-10-14
ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]
ColorTrack identification Tape2019-10-14
ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]
Bard-Parker Scalpel Blade Remover2019-10-14
ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]
Sterile Medication Label with or without Utility Marker2019-10-14
ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]
Headband2019-10-14
ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]
Sterion Pin Cover2019-10-14
ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]
Hoffee Suture Retriever2019-10-14
ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]
Green Genie Suture Passer2019-10-14
ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]
Surgical Light System (TruLight 3000, TruLight 5000, iLED7) and accessories [Trumpf]2019-10-14
ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]
OR Camera Cover and Accessories (Aspen)2019-10-14
ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]
Sterion Tube Holder2019-10-14
ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]
Sterion Surgical Tape2019-10-14
ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]
Sterion Vessel Loops2019-10-14
ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]
Sterion Suture Boots2019-10-14
ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]
Sterion Clamp covers2019-10-14
ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]
Richard Allan Vessel Loops2019-10-14
ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]
Richard Allan Safety Pin2019-10-14
ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]
Richard Allan Tonsil Snare2019-10-14
ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]
Richard Allan Nasal Snare2019-10-14
Aspen Surgical Puerto Rico Corp. [Aspen Surgical]
Bard-Parker [Aspen]2019-10-14
Aspen Surgical Puerto Rico Corp. [Aspen Surgical]
Bard-Parker Plus Surgical Blade with Loader [Aspen]2019-10-14
ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]
Bard-Parker [Aspen]2019-10-14
ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]
Bard-Parker Plus Surgical Blade with Loader [Aspen]2019-10-14
Aspen Surgical Puerto Rico Corp. [Aspen Surgical]
SafeSwitch2019-10-14
Aspen Surgical Puerto Rico Corp. [Aspen Surgical]
Bard-Parker2019-10-14
ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]
SafeSwitch2019-10-14
ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]
Bard-Parker2019-10-14
Aspen Surgical Puerto Rico Corp. [Aspen Surgical]
Mini-Scalpel2019-10-14
Aspen Surgical Puerto Rico Corp. [Aspen Surgical]
Bard-Parker2019-10-14
ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]
Mini-Scalpel2019-10-14
ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]
Bard-Parker2019-10-14
ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]
Surgidyne Wound Drainage2019-10-14
ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]
Richard-Allan Disposa-a-Tu2019-10-14
ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]
Write-Site Skin Marker2019-10-14
ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]
Write-Site Plus Skin Marker2019-10-14
ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]
Securline Skin Marker2019-10-14
ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]
Richard Allan Skin Marker2019-10-14
ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]
Cardinal2019-10-14
ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]
Aspen2019-10-14
ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]
Transfer Tray2019-10-14
ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]
Sterion Syringe and Scalpel Holder2019-10-14
ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]
Sterion Syringe Cup2019-10-14
ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]
Needle Nest2019-10-14
ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]
Instrument Mat2019-10-14
ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]
Sponge Bowl2019-10-14
ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]
Fluid bowl2019-10-14
ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]
Aspen Basin2019-10-14

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Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020090231121Genova,Italy -> New York/Newark Area, Newark, New JerseyFILTERS1002 CTN
2020082554764Genova,Italy -> New York/Newark Area, Newark, New JerseyFILTERS1002 CTN
2020071743185Hong Kong,Hong Kong -> San Juan, Puerto RicoDISPOSABLE GLOVES158 PCS
2020071551931Hong Kong,Hong Kong -> San Juan, Puerto RicoDISPOSABLE GLOVES158 PCS
202005265242Genova,Italy -> New York/Newark Area, Newark, New JerseyFILTERS1098 CTN
2020051618668Genova,Italy -> New York/Newark Area, Newark, New JerseyFILTERS1098 CTN
2020030717700Genova,Italy -> New York/Newark Area, Newark, New JerseyFILTERS1140 CTN
2020022733960Genova,Italy -> New York, New YorkFILTERS1140 CTN

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