FDA Registration Active 🇺🇸 United States

ASPEN SURGICAL PRODUCTS, INC.

Reg #: 1836161 · FEI: 3002750084 · Expires 2026
Products
655
Proprietary Names
118
Establishment Types
5
Classifications
655

Registration Details

Registration Name
ASPEN SURGICAL PRODUCTS, INC.
Registration Number
1836161
FEI Number
3002750084
Status
Active
Expiry Year
2026
Initial Importer
Yes
Address
6945 SOUTHBELT DR. S.E.
City
Caledonia
State
MI
ZIP
49316
Country
US

Regulatory Submissions

510(k) Number
K970893

Owner / Operator

Firm Name
Aspen Surgical Products
Operator Number
10061390
Address
6945 Southbelt Drive S.E.
City
Caledonia
State
MI
Postal Code
49316
Country
US
Correspondent
Christopher Smith

Products

Device Name Product Code
Refractometer, Ophthalmic HKO
Instrument, Diamond, Dental DZP
Drape, Surgical, Antimicrobial KKX
Gown, Surgical FYA
Needle, Neurosurgical Suture HAS
Carrier, Amalgam, Operative EKI
Chisel, Middle-Ear JYE
Electrocautery, Gynecologic (And Accessories) HGI
Electrosurgical, Cutting & Coagulation & Accessories GEI
Elevator, Surgical, Dental EMJ
Protector, Skin Pressure FMP
Bougie, Urological FAX
Scissors, Ear JZB
Solution, Lugol'S IAM
Unit, Cautery, Thermal, Battery-Powered HQP
Punch, Ethmoid KAX
Device, Transfer, Patient, Manual FMR
Catheter, Balloon Type GBA
Laparoscope, Gynecologic (And Accessories) HET
Retractor, Self-Retaining, For Neurosurgery GZT
Bandage, Cast ITG
Halter, Head, Traction HSS
Set, Hollow Mill HWL
Forceps, Tube Introduction BWB
Blade, Saw, Surgical, Cardiovascular DWH
Pin, Retentive And Splinting, And Accessory Instruments EBL
Tap, Bone HWX
Scalpel, One-Piece GDX
Clamp, Umbilical HFW
Chair, Surgical, Non-Electrical FZK
Instrument, Cutting, Operative EKD
Forceps HTD
Coagulator, Culdoscopic (And Accessories) HFI
Hook, Ophthalmic HNQ
Rongeur, Lachrymal Sac HNG
Device, Fixation, Tracheal Tube CBH
Laparoscope, General & Plastic Surgery GCJ
Clamp, Circumcision HFX
Rongeur, Manual HAE
Shield, Nipple HFS
Passer HWQ
Light, Surgical, Floor Standing FSS
File HTP
Irrigator, Sinus KAR
Crimper, Wire, Ent, Sterile JXT
Expander, Surgical, Skin Graft FZW
Clamp HXD
Brush, Scrub, Operating-Room GEC
Rongeur, Mastoid JZA
Pusher, Socket HXO
Rasp HTR
Absorbent, Carbon-Dioxide CBL
Absorber, Saliva, Paper KHR
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories KCT
Instrument, Surgical, Disposable KDC
Cannula, Sinus KAM
Curette, Adenoid KBJ
Dilator, Vessel, Surgical DWP
Mask, Surgical FXX
Curette, Surgical, Dental EMK
Hook, Microsurgical Ear JYL
Tamp HXG
Arthroscope HRX
Appliance, Facial Fracture, External FYI
Speculum, Vaginal, Metal HDF
Curette HTF
Mobilizer, Ent KAJ
Specula Accessories FXG
Snare, Nasal KBE
Rasp, Ear JYY
Applier, Hemostatic Clip HBT
Articulators EJP
Applicator, Absorbent Tipped, Sterile KXG
Burr, Orthopedic HTT
Clamp, Rubber Dam EEF
Bandage, Elastic FQM
Shield, Protective, Personnel KPY
Forceps, Ophthalmic HNR
Handle, Scalpel GDZ
Headrest, Neurosurgical HBM
Unit, Oral Irrigation EFS
Catheter, Cholangiography GBZ
Burr, Corneal, Battery-Powered HOG
Gown, Examination FME
Forceps, Wire Holding HYA
Holder, Needle, Gastroenterologic FHQ
Curette, Ethmoid KAO
Protector, Dental BRW
Device, Medical Examination, Ac Powered KZF
Saw HSO
Table, Operating-Room, Electrical GDC
Block, Cutting, Ent, Non-Sterile NNR
Mouthpiece, Breathing BYP
Scissors, Wire Cutting, Ent, Sterile JYA
Template HWT
Rasp, Frontal-Sinus KAZ
Accessory, Surgical Apparel LYU
Trocar, Laryngeal KAB
Microscope, Surgical EPT
Walker, Mechanical ITJ
Retainer, Matrix JEP
Prealbumin, Fitc, Antigen, Antiserum, Control DDS
Probe, Lachrymal HNL
Tray, Surgical LRP
Brush, Biopsy, General & Plastic Surgery GEE
Cleaner, Ultrasonic, Medical Instrument FLG
Post, Root Canal ELR
Sizer, Heart-Valve, Prosthesis DTI
Retractor, Fiberoptic FDG
Carver, Wax, Dental EIK
Device, Intravascular Catheter Securement KMK
Chair And Table, Medical KMN
Condenser, Amalgam And Foil, Operative EKG
Stocking, Medical Support (For General Medical Purposes) FQL
Adaptor, Bulbs, Miscellaneous, For Endoscope FFY
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
Clamp, Vascular DXC
Device, Rebreathing BYW
Holder, Ear Speculum JYK
Retractor, Self-Retaining FFO
Punch, Attic JYX
Scoop FHL
Snare, Enucleating HNE
Marker, Ocular HMR
Mirror, Ent KAI
Chair, With Casters INM
Culdoscope (And Accessories) HEW
Cannula, Ophthalmic HMX
Tube, Laryngectomy KAC
Perimeter, Ac-Powered HOO
Bur, Dental EJL
Retractor, Non-Self-Retaining FGN
Bag, Ice KYR
Instrument, Clip Removal HBQ
Snare, Ear JZD
Contractor, Surgical FZR
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) HOY
Press, Vein JYW
Corkscrew HWI
Dilator, Rectal FFP
Punch, Femoral Neck HWP
Prism, Gonioscopic HKS
Trocar, Tracheal KCI
Instrument, Hand, Calculus Removal ELA
Instrument, Ligature Passing And Knot Tying HCF
Wrench HXC
Wax, Dental, Intraoral EGD
Cup, Prophylaxis EHK
Clamp, Eyelid, Ophthalmic HOD
Insufflator, Laparoscopic HIF
Cover, Barrier, Protective MMP
Tube, Tonsil Suction KCB
Plier, Crimp FJY
Osteotome, Manual GFI
Holder, Needle; Orthopedic HXK
Forceps, Surgical, Gynecological HCZ
Applier, Surgical, Clip GDO
Sling, Arm ILI
Snare, Tonsil KBZ
Flowmeter, Tube, Thorpe, Back-Pressure Compensated CAX
Screw, Oral KBW
Motor, Surgical Instrument, Pneumatic Powered GET
Speculum, Non-Illuminated FXE
Dilator, Cervical, Fixed Size HDQ
Skid, Bone HWO
Accessories, Photographic, For Endoscope (Exclude Light Sources) FEM
Laryngoscope, Rigid CCW
Clamp, Ossicle Holding JYF
Tourniquet, Nonpneumatic GAX
Aid, Transfer IKX
Sound, Urethral, Metal Or Plastic FBX
Tourniquet, Gastro-Urology EYR
Amniotome HGE
Knife, Surgical EMF
Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use JQC
Ring, Laparotomy FHI
Illuminator, Non-Remote FTF
Holder, Film, X-Ray EGZ
Reamer HTO
Mallet, Surgical, General & Plastic Surgery GFJ
Orthosis, Cervical IQK
Curette, Operative EKE
Mallet HXL
Holder, Camera, Surgical FXR
Loop, Wire JYQ
Forceps, Obstetrical HDA
Crimper, Pin HXQ
Catheters, Suction, Tracheobronchial BSY
Gouge, Nasal, Ent KAQ
Cap, Surgical FYF
Knife, Ear JYO
Elevator, Ent KAD
Cabinet, Table And Tray, Anesthesia BRY
Gouge, Surgical, General & Plastic Surgery GDH
Catheter And Tip, Suction JOL
Applier, Staple, Surgical, GEF
Forceps, Disconnect FJR
Ligator, Hemorrhoidal FHN
File, Periodontic EMR
Circuit, Breathing (W Connector, Adaptor, Y Piece) CAI
Instrument, Measuring, Corneal Radius HJB
Device, Percutaneous, Biopsy MJG
Perforator, Antrum KAT
Stripper, Vein, Reusable GAI
Retractor GAD
Tonsillectome KCA
Unit, Examining/Treatment, Ent ETF
Instrument, Manual, General Obstetric-Gynecologic KOH
Saw, Pneumatically Powered KFK
Forceps, Articulation Paper EFK
Bell, Circumcision FHG
Stimulator, Nerve ETN
Stool, Operating-Room FZM
Blower, Powder, Ent KCL
Light, Examination, Medical, Battery Powered KYT
Indicator, Physical/Chemical Sterilization Process JOJ
Apparatus, Exhaust, Surgical FYD
Headlamp, Operating, Battery-Operated HPP
Retractor, Vaginal HDL
Stylet, Surgical, General & Plastic Surgery GAH
Dynamometer, Nonpowered HRW
Clamp, Muscle, Ophthalmic HOB
Scaler, Periodontic EMN
Gauge, Mastoid JYI
Nebulizer, Medicinal, Non-Ventilatory (Atomizer) CCQ
Marker, Periodontic EMP
Bag, Urine Collection, Newborn FOC
Dressing, Wound, Occlusive NAD
Transducer, Ultrasonic, Diagnostic ITX
Unit, Suction Operatory EBR
Sucker, Cardiotomy Return, Cardiopulmonary Bypass DTS
Fiber, Medical, Absorbent FRL
Carver, Dental Amalgam, Operative EKH
Support, Patient Position CCX
Trephine HWK
Forceps, Dressing, Dental EFL
Knife, Nasal KAS
Retractor, All Types EIG
Clamp, Line FKK
Forceps, Rongeur, Surgical EMH
Hook, Tonsil Suturing KBP
Needle, Hypodermic, Single Lumen FMI
Container, Sharps MMK
Test, Leukocyte Alkaline Phosphatase GHD
Pliers, Operative EJY
Catheter, Eustachian, General & Plastic Surgery GBY
Humidifier, Non-Direct Patient Interface (Home-Use) KFZ
Drain, Tee (Water Trap) BYH
Warmer, Anesthetic Tube EFC
Ring, Ophthalmic (Flieringa) HNH
Needle, Ophthalmic Suturing HNM
Locator, Magnetic FTZ
Source, Carrier, Fiberoptic Light EQH
Knife, Margin Finishing, Operative EJZ
Floss, Dental JES
Fork, Tuning GWX
Forceps, Rubber Dam Clamp EJG
Pick, Microsurgical Ear JYT
Hemostat, Surgical EMD
Scissors, Nasal KBD
Applicator, Ent KCJ
Rasp, Surgical, General & Plastic Surgery GAC
Plier, Orthodontic JEX
Handle, Instrument, Dental EJB
Microscope, Operating & Accessories, Ac-Powered, Ophthalmic HRM
Awl HWJ
File, Pulp Canal, Endodontic EKS
Knife, Laryngeal JZY
Loupe, Diagnostic/Surgical FSP
Cotton, Roll EFN
Brush, Dermabrasion, Manual GED
Wrap, Sterilization FRG
Curette, Ear JYG
Tray, Impression, Preformed EHY
Dermatome GFD
Cannula, Nasal, Oxygen CAT
Instruments, Surgical, Cardiovascular DWS
Microscope, Surgical, General & Plastic Surgery FSO
Chisel, Mastoid JYD
Solution, Formalin-Alcohol-Acetic Acid IGF
Spreader, Pulp Canal Filling Material, Endodontic EKK
Clasp, Wire EJW
Battery, Replacement, Rechargeable MOQ
Dilator, Catheter GCC
Magnet, Permanent HPN
Expressor HNS
Bed, Manual FNJ
Pack, Hot Or Cold, Disposable IMD
Curette, Periodontic EMS
Stretcher, Hand-Carried FPP
Blade, Saw, General & Plastic Surgery, Surgical GFA
Cannulae, Bronchial KCE
Knife, Periodontic EMO
Instrument, Compression HWN
Saw, Manual And Accessories GDR
Ring Cutter FNS
Tong, Skull For Traction HAX
Forceps, Wire Closure, Ent, Sterile JXX
Frame, Rubber Dam EJE
Orthopedic Manual Surgical Instrument LXH
Jig, Piston Cutting, Ent, Sterile JXY
Die, Wire Bending, Ent, Sterile JXW
Chisel, Osteotome, Surgical EMM
Reamer, Pulp Canal, Endodontic EKP
Rack, Clip HBR
File, Bone, Surgical EMI
Cover, Mattress (Medical Purposes) FMW
Splint, Nasal EPP
Flowmeter, Calibration, Gas BXY
Instrument, Filling, Plastic, Dental EIY
Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment HSZ
Apparatus, Suturing, Stomach And Intestinal FHM
Apparatus, Electrosurgical HAM
Camera, Television, Surgical, With Audio FWC
Clip, Removable (Skin) FZQ
Splint, Extremity, Inflatable, External FZF
Container, Specimen Mailer And Storage, Sterile KDT
Hammer, Surgical FZY
Mirror, Headband, Ophthalmic HKF
Dilator, Lachrymal HNW
Erisophake HNT
Set, Lens, Trial, Ophthalmic HPC
Hoe, Periodontic EMQ
Lens, Condensing, Diagnostic HJL
Goniometer, Nonpowered KQW
Cushion, Flotation KIC
Twister, Wire HXS
Trocar, Sinus KBG
Bur, Surgical, General & Plastic Surgery GFF
Needle, Catheter GCB
Exophthalmometer HLS
Snare, Surgical GAE
Stylet, Tracheal Tube BSR
Punch, Biopsy, Surgical EME
Dilator, Tracheal KCG
Calibrator, Volume, Gas BXW
Bougie, Eustachian KBI
Inserter, Myringotomy Tube JYM
Erythrosin B KJR
Forceps, Biopsy, Gynecological HFB
Spoon, Ophthalmic HNB
Hook, Fibroid, Gynecological HDE
Forceps, General & Plastic Surgery GEN
Camera, Still, Endoscopic FXM
Needle, Suturing, Reusable GDL
Nipper, Malleus JYR
Retractor, Ophthalmic HNI
Tray, Surgical, Instrument FSM
Clamp, Non-Electrical FFN
Pliers, Surgical HTC
Rasp, Nasal KBA
Chisel (Osteotome) KDG
Saw, Powered, And Accessories HAB
Clamp, Cannula FKC
Clip, Aneurysm HCH
Dissector, Surgical, General & Plastic Surgery GDI
Instrument, Bending Or Contouring HXP
Excavator, Dental, Operative EKC
Excavator, Ear JYH
Bit, Drill HTW
Brush, Cleaning, Tracheal Tube EPE
Broach HTQ
Stand, Infusion FOX
Guide, Needle, Surgical GDF
Zinc Oxide Eugenol EMB
Syringe, Ent KCP
Light, Surgical, Ceiling Mounted FSY
Basin, Emesis FNY
Clip, Scalp HBO
Probe, Rectal, Non-Powered EXX
Non-Surgical Gown OEA
Caliper, Ophthalmic HOE
Ruler, Nearpoint (Punctometer) HLE
Adaptor, Catheter GCE
Guide, Surgical, Instrument FZX
Snare, Non-Electrical FGX
Discriminator, Two-Point GWI
Knife, Orthopedic HTS
Needle, Suturing, Disposable GAB
Unit, Filter, Membrane JRL
Strip, Adhesive, Closure, Skin FPX
Kit, Surgical Instrument, Disposable KDD
Instrument, Ligature Tucking, Orthodontic ECP
Spatula, Surgical, General & Plastic Surgery GAF
Instrument, Microsurgical GZX
Hook, Surgical, General & Plastic Surgery GDG
Marker, Sclera HMQ
Mirror, General & Plastic Surgery FTX
Dam, Rubber EIE
Label Or Tag, Sterile LYV
Gauge, Lens, Ophthalmic HLN
Gauge, Depth, Instrument, Dental EIL
Holder, Ureteral Catheter EYJ
Bedding, Disposable, Medical KME
Cutter, Wire HXZ
Block, Cutting, Ent, Sterile JXS
Photokeratoscope HJA
Forceps, Ent KAE
Calibrator, Pressure, Gas BXX
Airway, Oropharyngeal, Anesthesiology CAE
Cannula, Surgical, General & Plastic Surgery GEA
Instrument, Surgical, Non-Powered HAO
Spud, Ophthalmic HNA
Cannula, Ear JYC
Tubing, Pressure And Accessories BYX
Tube, Tracheostomy (W/Wo Connector) BTO
Trephine, Sinus KBF
Adenotome KBH
Motor, Surgical Instrument, Ac-Powered GEY
Pen, Marking, Surgical HRP
Bistoury, Tracheal KCC
Curette, Ophthalmic HNZ
Carrier, Ligature GEJ
Stripper, Surgical HRT
Positioner, Tooth, Preformed KMY
Regulator, Pressure, Gas Cylinder CAN
Bur, Ear, Nose And Throat EQJ
Binder, Perineal FQK
Curette, Uterine HCY
Cover, Shoe, Operating-Room FXP
Probe, Trabeculotomy HNK
Punch, Nasal KAY
Curette, Nasal KAP
Drill, Dental, Intraoral DZA
Tent, Oxygen BYL
Stethoscope, Fetal HGN
Instrument, Contouring, Matrix, Operative EKF
Starter, Bone Screw HWD
Agent, Polishing, Abrasive, Oral Cavity EJR
Gauze/Sponge, Internal, X-Ray Detectable GDY
Clip, Lens, Trial, Ophthalmic HPB
Chair, Examination And Treatment FRK
Scissors, Medical, Disposable JOK
Saw, Electrically Powered DWI
Table, Instrument, Powered, Ophthalmic HRJ
Airway, Nasopharyngeal BTQ
Handpiece (Brace), Drill HBD
Scissors, General, Surgical LRW
Instrument, Cutting, Orthopedic HTZ
Set, Laryngeal Injection KAA
Brush, Dermabrasion, Powered GFE
Introducer, Sphere HNP
Burr, Corneal, Manual HOF
Clip, Iris Retractor HOC
Chisel, Nasal KAN
Saw, Nasal KBC
Trephine, Manual, Ophthalmic HRH
Probe And Director, Gastro-Urology FGM
Mask, Oxygen, Non-Rebreathing KGB
Cannula, Ventricular HCD
Cover, Limb IPM
Pick, Massaging JET
Dressing, Wound, Drug FRO
Strap, Head, Gas Mask BTK
Needle, Biopsy, Cardiovascular DWO
Dilator, Esophageal, Ent KCF
Punch, Tonsil KBT
Chisel, Surgical, Manual FZO
Sound, Metal, Interconnected FBS
Spoon, Ear JZE
Screwdriver HXX
Clip, Nose BXJ
Eye, Artificial, Non-Custom HQH
Passer, Wire, Orthopedic HXI
Disk, Abrasive EHJ
Balloon, Epistaxis EMX
Brace, Drill HXY
Curette, Surgical, General Use FZS
Retractor, Ent KAL
Knife, Tonsil KBQ
Instrument, Shunt System Implantation GYK
Instrument, Catheter, Punch FEX
Remover, Crown EIS
Retainer, Surgical GCZ
Speculum, Illuminated FXF
Pump, Nebulizer, Electrically Powered JPW
Depressor, Metal Tongue, Surgical KBL
Syringe, Restorative And Impression Material EID
Searcher, Mastoid JZC
Probe, Ent KAK
Scissors, Collar And Crown EIR
Unit, Drying JRJ
Plate, Base, Shellac EEA
Coagulator-Cutter, Endoscopic, Bipolar (And Accessories) HIN
Mask, Oxygen BYG
Knife, Myringotomy JYP
Countersink HWW
Hook, Bone KIK
Sheet, Burn FPY
Apparatus, Traction, Non-Powered HST
Scissors, Episiotomy HDK
Tape And Bandage, Adhesive KGX
Adaptor, Holder, Syringe IQG
Cannula, Injection FGY
Dissector, Tonsil KBM
Tape, Measuring, Rulers And Calipers FTY
Pelvimeter, External HER
Refractor, Manual, Non-Powered, Including Phoropter HKN
Positioner, Socket KIL
Rongeur HTX
Sound, Uterine HHM
Instruments, Dental Hand DZN
Hemostat HRQ
Unit, Heating, Powered IRQ
Component, Traction, Non-Invasive KQZ
Evacuator, Oral Cavity EHZ
Knife, Amputation GDN
Unit, Syringe, Air And/Or Water ECB
Pinwheel GWY
Catheter, Peritoneal GBW
Hook, Gastro-Urology FHB
Pad, Eye HMP
Bar, Preformed EHO
Tubing, Noninvasive GAZ
Cystotome HNY
Splint, Traction HSP
Osteotome HWM
Stylet For Catheter, Gastro-Urology EZB
Binder, Elastic KMO
Scissors, Ophthalmic HNF
Accessories, Cleaning Brushes, For Endoscope MNL
Knife, Ophthalmic HNN
Bag, Urine Collection, Leg, For External Use, Sterile FAQ
Speculum, Rectal FFQ
Yoke Assembly, Medical Gas CAM
Camera, Surgical And Accessories KQM
Needle, Tonsil Suturing KBR
Transilluminator, Fiber Optic MQW
Drills, Burrs, Trephines & Accessories (Simple, Powered) HBE
Table, Surgical With Orthopedic Accessories, Manual JEB
Rod, Measuring Ear JYZ
Scissors, Orthopedic, Surgical HRR
Extractor HWB
Clip, Implantable FZP
Accessories, Retractor, Dental EIF
Blade, Scalpel GES
Punch, Skull GXJ
Broach, Endodontic EKW
Hand, External Limb Component, Mechanical IRA
Spatula, Orthopedic HXR
Tube, Ear Suction JZF
Table And Attachments, Operating-Room BWN
Point, Silver, Endodontic EKL
Scissors, Umbilical HDJ
Probe, Uptake, Nuclear IZD
Bender HXW
Needle, Aspiration And Injection, Disposable GAA
Container, Specimen, Sterile FMH
Driver, Surgical, Pin GFC
Plugger, Root Canal, Endodontic EKR
Refractometer For Clinical Use JRE
Film, Radiographic IWZ
Toothbrush, Manual EFW
Drills, Burrs, Trephines & Accessories (Manual) HBG
Specula, Ophthalmic HNC
Spatula, Ophthalmic HND
Shield, Eye, Radiological IWS
Chart, Visual Acuity HOX
Instrument, Measuring, Lens, Ac-Powered HLM
Speculum, Ent EPY
Elevator HTE
Evacuator, Bladder, Manually Operated FFD
Pusher, Band, Orthodontic ECS
Bath, Incubators/Water, All JTQ
Needle, Aspiration And Injection, Reusable GDM
Chair, Surgical, Ac-Powered GBB
Stimulator, Caloric-Air KHH
Packer, Uterine HDM
Mask, Oxygen, Low Concentration, Venturi BYF
Urinal FNP
Bougie, Esophageal, Ent KCD
Mirror, Mouth EAX
Bedpan FOB
Percussor GWZ
Unit, Electrosurgical And Coagulation, With Accessories BWA
Forceps, Tooth Extractor, Surgical EMG
Catheter, Irrigation GBX
Punch, Corneo-Scleral HNJ
Probe, Periodontic EIX
Collagen Corneal Shield MOE
Needle, Gastro-Urology FHR
Catheter, Multiple Lumen GBP
Chair, Blood Donor FML
Speculum, Vaginal, Nonmetal HIB
Paper, Articulation EFH
Elevator, Surgical, General & Plastic Surgery GEG
Table, Operating-Room, Manual FSE
Tonometer, Manual HKY
Wire, Orthodontic DZC
Anvil, Skull Plate GXM
Sampler, Amniotic Fluid (Amniocentesis Tray) HIO
Retention Device, Suture KGS
Instrument, Manual, Surgical, General Use MDM
Gutta-Percha EKM
Trabeculotome HMZ
Tourniquet, Automatic Rotating DRP
Lens, Maddox HKR
Tube, Smoke Removal, Endoscopic FCZ
Perimeter, Automatic, Ac-Powered HPT
Surgical Instruments, G-U, Manual (And Accessories) KOA
Ear Wick KCN
Clamp, Uterine HGC
Light, Surgical, Accessories FTA
Depressor, Tongue, Non-Surgical FMA
Burnisher, Operative EKJ
Syringe, Periodontic, Endodontic, Irrigating EIC
Crutch, Ptosis HJZ
Marker, Skin FZZ
Cutter, Surgical FZT
Preparer, Root Canal Endodontic EKQ
Screw, Tonsil KBX
Splint, Hand, And Components ILH
Probe HXB
Accessories, Catheter KGZ
Otoscope ERA
Hook, Tracheal KCH
Gag, Mouth KBN
Driver, Prosthesis HWR
Gauge, Depth HTJ
Camera, Cine, Endoscopic, With Audio FTS
Restraint, Wheelchair, Non-Protective KID
Holder, Speculum, Ent KAG
Transducer, Gas Flow BXP
Fork HXE
Strip, Polishing Agent EHM
Stylet, Ureteral EYA
Impactor HWA
Device, Locking, For Intestinal Clamp FFR
Gauge, Measuring JYJ
Anti Fog Solution And Accessories, Endoscopy OCT
Set, Tubing And Support, Ventilator (W Harness) BZO
Explorer, Operative EKB
Forceps, Biopsy, Non-Electric FCL
Punch, Adenoid KBS
Clamp, Surgical, General & Plastic Surgery GDJ
Loupe, Binocular, Low Power HJH
Helmet, Surgical FXZ
Depressor, Orbital HNX
Pack, Hot Or Cold, Reusable IME
Magnifier, Hand-Held, Low-Vision HJF
Tray, Start/Stop (Including Contents), Dialysis FKG
Clamp, Penile FHA
Stripper, Vein, Disposable GAJ
Staple, Removable (Skin) GDT
Curette, Endodontic EKT
Apparatus, Suction, Single Patient Use, Portable, Nonpowered GCY
Mattress, Flotation Therapy, Non-Powered IKY
Catheter, Nasal, Oxygen BZB
Rongeur, Nasal KBB
Frame, Trial, Ophthalmic HPA
Chisel, Bone, Surgical EML
Remover, Intrauterine Device, Contraceptive, Hook-Type HHF
Flowmeter, Nonback-Pressure Compensated, Bourdon Gauge CCN
Punch, Antrum KAW
Light, Surgical Headlight EBA

Proprietary Names

Symmetry Surgical Pull Up Shields Probe Cover Bovie Medical Olsen Medical Mini-Scalpel Bard-Parker Umbilical Cord Clamp Sterion Clamp covers Richard Allan Safety Pin Richard Allan Vessel Loops Sterion Vessel Loops Sterion Suture Boots Precept Richard Allan Nasal Snare Collection Swab Headband Cygnus Medical kittner System Drapes Richard Allan Tonsil Snare AMNIHOOK AMNIOTIC MEMBRANE PERFORATOR Symmetry Cautery Tip Cleaner PLASTIBELL CIRCUMCISION DEVICE ErgoSupport Step Stool Symmetry Surgical Inc. Probe Cover, Endocavity U-BAG URINE SPECIMEN COLLECTORS FIRST TIME URINE SPECIMEN COLLECTOR PREMIE URINE SPECIMEN COLLECTORS transparent dressing Needle Guides, General Purpose Norton Arm Kit Erin Mask Replacement Strap Dr Don's Arm Suspension Kit Montana Indy Beach Chair Face Mask MD Traction Rope Lewiston Hip Kit Prone Face Pillow Universal Head Restraint Sedona Arm Cradle Leg Comfort Pad Parent Post Pad Dr. Don's Arm Canoe - V Hermanator Knee Positioning Pad Pink XL Hermanator Knee Pad Marco Shoulder Stabilization Kit Erin Mask TLC Distraction Pad Set Jessie Arm Suspension Kit Smoot Ankle Distraction Foot Strap Dr Don's Arm Suspension Kit Northern Bethesda Face Mask Berkette Beach Chair Limb Positioner Seattle Brachy Bed Patient Care Boot Insert Thigh Holder Pad Lindy Boot Liner Dr Don's Arm Suspension Kit Racine Pelvic Positioning Pad Lateral Positioner Pad Set Beach Chair Head and Chin Straps Carson Perineal Post Pad Dr. Don's Arm Canoe Perineal Post Cover Hana Hip Kit Aspen Needle Container Aspen Needle Counter Sterion Pin Cover Green Genie Suture Passer Hoffee Suture Retriever CS Medical Transfer Tray Sterion Syringe Cup Needle Nest Sterion Syringe and Scalpel Holder Instrument Mat Simeon Medical Richard-Allan Disposa-a-Tu Sterion Wound Closure Sterile Medication Label with or without Utility Marker BlueMed Sterion Tube Holder Sterion Surgical Tape Cardinal Aspen SafeClean brushes MABIS OR Camera Cover and Accessories (Aspen) Surgical Light System (TruLight 3000, TruLight 5000, iLED7) and accessories [Trumpf] Bard-Parker [Aspen] Sponge Bowl Aspen Basin Fluid bowl ColorTrack identification tags Sterion Labels Non-Sterile Medication Labels Tube Holder with Removable Strap Bard-Parker Scalpel Blade Remover Sterion Tip Protectors ColorTrack identification Tape Sterion Locking Tags Web Guards Oxboro Instrument Tip Protectors Write On Labels ALC Plus Disposable Light Handle Cover Adaptors Light Handle Covers Write-Site Plus Skin Marker Richard Allan Skin Marker Securline Skin Marker Write-Site Skin Marker DOUBLE-GRIP UMBILICAL CORD CLAMP Dr. Fog anti-fog Laparoscope, Dr. Fog solution Surgidyne Wound Drainage

Establishment Types

Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device Repack or Relabel Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)