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 Number: 1836161
• FEI Number: 3002750084
• Name: ASPEN SURGICAL PRODUCTS, INC.
• Owner & Operator: Aspen Surgical
• Contact Address: 6945 Southbelt Drive S.E. ; Caledonia MI 49316 US
• Official Correspondent:
  • Michelle Pulaski
  • x-616-6987100-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 6945 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 Number: 2649798
• FEI Number: 2649798
• Name: Aspen Surgical Puerto Rico Corp.
• Owner & Operator: Aspen Surgical
• Contact Address: 6945 Southbelt Drive S.E. ; Caledonia MI 49316 US
• Official Correspondent:
  • Michelle Pulaski
  • x-616-6987100-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: RD. 183, KM. 20.3 ; LAS PIEDRAS, PR 00771 US
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
FZM ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]	ErgoSupport Step Stool	2020-01-24
CCX ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]	Universal Head Restraint	2020-01-24
CCX ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]	Thigh Holder Pad	2020-01-24
CCX ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]	TLC Distraction Pad Set	2020-01-24
CCX ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]	Smoot Ankle Distraction Foot Strap	2020-01-24
CCX ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]	Sedona Arm Cradle	2020-01-24
CCX ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]	Seattle Brachy Bed	2020-01-24
CCX ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]	Racine Pelvic Positioning Pad	2020-01-24
CCX ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]	Prone Face Pillow	2020-01-24
CCX ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]	Pink XL Hermanator Knee Pad	2020-01-24
CCX ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]	Perineal Post Cover	2020-01-24
CCX ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]	Patient Care Boot Insert	2020-01-24
CCX ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]	Parent Post Pad	2020-01-24
CCX ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]	Norton Arm Kit	2020-01-24
CCX ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]	Montreal Hip Positioner	2020-01-24
CCX ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]	Marco Shoulder Stabilization Kit	2020-01-24
CCX ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]	MD Traction Rope	2020-01-24
CCX ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]	Lindy Boot Liner	2020-01-24
CCX ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]	Lewiston Hip Kit	2020-01-24
CCX ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]	Leg Comfort Pad	2020-01-24
CCX ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]	Lateral Positioner Pad Set	2020-01-24
CCX ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]	Jessie Arm Suspension Kit	2020-01-24
CCX ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]	JEMS Triangle Pad	2020-01-24
CCX ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]	Indy Beach Chair Face Mask	2020-01-24
CCX ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]	Hermanator Knee Positioning Pad	2020-01-24
CCX ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]	Extended Elbow Pad	2020-01-24
CCX ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]	Erin Mask	2020-01-24
CCX ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]	Erin Mask Replacement Strap	2020-01-24
CCX ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]	Dr. Don's Arm Canoe	2020-01-24
CCX ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]	Dr. Don's Arm Canoe - V	2020-01-24
CCX ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]	Dr Don's Arm Suspension Kit	2020-01-24
CCX ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]	Dr Don's Arm Suspension Kit Northern	2020-01-24
CCX ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]	Dr Don's Arm Suspension Kit Montana	2020-01-24
CCX ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]	Carson Perineal Post Pad	2020-01-24
CCX ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]	Bethesda Face Mask	2020-01-24
CCX ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]	Berkette Beach Chair Limb Positioner	2020-01-24
CCX ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]	Beach Chair Head and Chin Straps	2020-01-24
PMN K951736 | MMK ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]	Aspen Needle Counter	2019-10-14
PMN K951736 | MMK ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]	Aspen Needle Container	2019-10-14
PMN K951736 | FMI ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]	Aspen Needle Counter	2019-10-14
PMN K951736 | FMI ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]	Aspen Needle Container	2019-10-14
PMN K932449 | OCT ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]	Laparoscope, Dr. Fog solution	2019-10-14
PMN K932449 | OCT ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]	Dr. Fog anti-fog	2019-10-14
PMN K913500 | GCJ ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]	kittner	2019-10-14
PMN K874813 | FPX ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]	Sterion Wound Closure	2019-10-14
PMN K030339 | GEI ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]	Cautery Tip Cleaner	2019-10-14
PMN K020304 | FTA ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]	Light Handle Covers	2019-10-14
PMN K020304 | FTA ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]	Adaptors	2019-10-14
PMN K020304 | FTA ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]	ALC Plus Disposable Light Handle Cover	2019-10-14
NAD ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]	transparent dressing	2019-10-14
MNL ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]	SafeClean brushes	2019-10-14
MDM ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]	Tube Holder with Removable Strap	2019-10-14
MDM ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]	Sterion Tip Protectors	2019-10-14
MDM ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]	Sterion Locking Tags	2019-10-14
MDM ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]	Sterion Labels	2019-10-14
MDM ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]	Non-Sterile Medication Labels	2019-10-14
MDM ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]	ColorTrack identification tags	2019-10-14
MDM ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]	ColorTrack identification Tape	2019-10-14
MDM ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]	Bard-Parker Scalpel Blade Remover	2019-10-14
LYV ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]	Sterile Medication Label with or without Utility Marker	2019-10-14
LYU ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]	Headband	2019-10-14
LXH ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]	Sterion Pin Cover	2019-10-14
LXH ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]	Hoffee Suture Retriever	2019-10-14
LXH ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]	Green Genie Suture Passer	2019-10-14
KQM ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]	Surgical Light System (TruLight 3000, TruLight 5000, iLED7) and accessories [Trumpf]	2019-10-14
KQM ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]	OR Camera Cover and Accessories (Aspen)	2019-10-14
KGX ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]	Sterion Tube Holder	2019-10-14
KGX ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]	Sterion Surgical Tape	2019-10-14
KDC ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]	Sterion Vessel Loops	2019-10-14
KDC ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]	Sterion Suture Boots	2019-10-14
KDC ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]	Sterion Clamp covers	2019-10-14
KDC ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]	Richard Allan Vessel Loops	2019-10-14
KDC ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]	Richard Allan Safety Pin	2019-10-14
KBZ ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]	Richard Allan Tonsil Snare	2019-10-14
KBE ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]	Richard Allan Nasal Snare	2019-10-14
GES Aspen Surgical Puerto Rico Corp. [Aspen Surgical]	Bard-Parker [Aspen]	2019-10-14
GES Aspen Surgical Puerto Rico Corp. [Aspen Surgical]	Bard-Parker Plus Surgical Blade with Loader [Aspen]	2019-10-14
GES ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]	Bard-Parker [Aspen]	2019-10-14
GES ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]	Bard-Parker Plus Surgical Blade with Loader [Aspen]	2019-10-14
GDZ Aspen Surgical Puerto Rico Corp. [Aspen Surgical]	SafeSwitch	2019-10-14
GDZ Aspen Surgical Puerto Rico Corp. [Aspen Surgical]	Bard-Parker	2019-10-14
GDZ ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]	SafeSwitch	2019-10-14
GDZ ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]	Bard-Parker	2019-10-14
GDX Aspen Surgical Puerto Rico Corp. [Aspen Surgical]	Mini-Scalpel	2019-10-14
GDX Aspen Surgical Puerto Rico Corp. [Aspen Surgical]	Bard-Parker	2019-10-14
GDX ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]	Mini-Scalpel	2019-10-14
GDX ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]	Bard-Parker	2019-10-14
GCY ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]	Surgidyne Wound Drainage	2019-10-14
GAB ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]	Richard-Allan Disposa-a-Tu	2019-10-14
FZZ ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]	Write-Site Skin Marker	2019-10-14
FZZ ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]	Write-Site Plus Skin Marker	2019-10-14
FZZ ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]	Securline Skin Marker	2019-10-14
FZZ ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]	Richard Allan Skin Marker	2019-10-14
FTY ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]	Cardinal	2019-10-14
FTY ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]	Aspen	2019-10-14
FSM ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]	Transfer Tray	2019-10-14
FSM ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]	Sterion Syringe and Scalpel Holder	2019-10-14
FSM ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]	Sterion Syringe Cup	2019-10-14
FSM ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]	Needle Nest	2019-10-14
FSM ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]	Instrument Mat	2019-10-14
FMH ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]	Sponge Bowl	2019-10-14
FMH ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]	Fluid bowl	2019-10-14
FMH ASPEN SURGICAL PRODUCTS, INC. [Aspen Surgical]	Aspen Basin	2019-10-14

Similar & Related FDA Registered Companies

• ASPEN SURGICAL PRODUCTS, INC.

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020090231121	Genova,Italy -> New York/Newark Area, Newark, New Jersey	FILTERS	1002 CTN
2020082554764	Genova,Italy -> New York/Newark Area, Newark, New Jersey	FILTERS	1002 CTN
2020071743185	Hong Kong,Hong Kong -> San Juan, Puerto Rico	DISPOSABLE GLOVES	158 PCS
2020071551931	Hong Kong,Hong Kong -> San Juan, Puerto Rico	DISPOSABLE GLOVES	158 PCS
202005265242	Genova,Italy -> New York/Newark Area, Newark, New Jersey	FILTERS	1098 CTN
2020051618668	Genova,Italy -> New York/Newark Area, Newark, New Jersey	FILTERS	1098 CTN
2020030717700	Genova,Italy -> New York/Newark Area, Newark, New Jersey	FILTERS	1140 CTN
2020022733960	Genova,Italy -> New York, New York	FILTERS	1140 CTN