Instrumed International Inc dba Avalign German Specialty Instruments

FDA Device Registration & Listing · SCHAUMBURG, IL, US · Registration 1421101

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1421101
FEI Number
1421101
Entity Name
Instrumed International Inc dba Avalign German Specialty Instruments
City/State/Country
SCHAUMBURG, IL, US
Establishment Address
626 Cooper Ct, SCHAUMBURG, IL 60173, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
Avalign Technologies (Owner Number: 10051835)
Owner / Operator Contact Address
110275 W. Higgins Rd, Suite 920, Rosemont, IL 60018, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HNM Needle, Ophthalmic Suturing Ophthalmic Class 1 886.4350 2016-11-21
FHR Needle, Gastro-Urology General, Plastic Surgery Class 1 878.4800 2016-11-17
FXG Specula Accessories General, Plastic Surgery Class 1 878.1800 2016-11-17
KAR Irrigator, Sinus Ear, Nose, Throat Class 1 874.4420 2016-11-21
KCB Tube, Tonsil Suction Ear, Nose, Throat Class 1 874.4420 2016-11-16
GFJ Mallet, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2016-11-16
JYH Excavator, Ear Ear, Nose, Throat Class 1 874.4420 2016-11-21
FFN Clamp, Non-Electrical Gastroenterology, Urology Class 1 876.4730 2016-11-21
HRX Arthroscope Orthopedic Class 2 888.1100 2018-02-19
GDR Saw, Manual And Accessories General, Plastic Surgery Class 1 878.4800 2016-11-17
EMG Forceps, Tooth Extractor, Surgical Dental Class 1 872.4565 2016-11-21
HNN Knife, Ophthalmic Ophthalmic Class 1 886.4350 2016-11-16
FZT Cutter, Surgical General, Plastic Surgery Class 1 878.4800 2016-11-21
HXB Probe Orthopedic Class 1 888.4540 2016-11-17
EJY Pliers, Operative Dental Class 1 872.4565 2016-11-17
HXX Screwdriver Orthopedic Class 1 888.4540 2016-11-17
HNR Forceps, Ophthalmic Ophthalmic Class 1 886.4350 2016-11-15
EHO Bar, Preformed Dental Class 1 872.3165 2016-11-17
KBP Hook, Tonsil Suturing Ear, Nose, Throat Class 1 874.4420 2016-11-21
EPY Speculum, Ent General, Plastic Surgery Class 1 878.1800 2016-11-17
HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3530 2020-03-11
HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3520 2020-03-11
NPJ Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2020-03-11
KRR Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3540 2020-03-11
HNQ Hook, Ophthalmic Ophthalmic Class 1 886.4350 2016-11-16
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2018-03-18
HTD Forceps General, Plastic Surgery Class 1 878.4800 2016-11-17
DWS Instruments, Surgical, Cardiovascular Cardiovascular Class 1 870.4500 2016-11-16
HRR Scissors, Orthopedic, Surgical Orthopedic Class 1 888.4540 2016-11-17
HIN Coagulator-Cutter, Endoscopic, Bipolar (And Accessories) Obstetrics/Gynecology Class 2 884.4150 2018-01-30
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2018-09-20
HTS Knife, Orthopedic Orthopedic Class 1 888.4540 2016-11-21
GEA Cannula, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2016-11-16
KAK Probe, Ent Ear, Nose, Throat Class 1 874.4420 2016-11-16
HND Spatula, Ophthalmic Ophthalmic Class 1 886.4350 2016-11-16
EKT Curette, Endodontic Dental Class 1 872.4565 2016-11-17
GWX Fork, Tuning Neurology Class 1 882.1525 2016-11-21
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2018-04-19
KCA Tonsillectome Ear, Nose, Throat Class 1 874.4420 2016-11-21
HCY Curette, Uterine Obstetrics/Gynecology Class 1 884.4530 2016-11-21
KTE Trocar, Ent Ear, Nose, Throat Class 1 874.4420 2016-11-16
HNI Retractor, Ophthalmic Ophthalmic Class 1 886.4350 2016-11-16
HTF Curette General, Plastic Surgery Class 1 878.4800 2016-11-16
GDJ Clamp, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2016-11-17
KBZ Snare, Tonsil Ear, Nose, Throat Class 1 874.4420 2016-11-17
EJB Handle, Instrument, Dental Dental Class 1 872.4565 2016-11-17
FTZ Locator, Magnetic Ophthalmic Class 1 886.4445 2018-05-30
GAC Rasp, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2016-05-09
DXC Clamp, Vascular Cardiovascular Class 2 870.4450 2016-09-21
GZT Retractor, Self-Retaining, For Neurosurgery Neurology Class 2 882.4800 2016-09-22
FZX Guide, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2016-11-21
JYL Hook, Microsurgical Ear Ear, Nose, Throat Class 1 874.4420 2016-11-21
HXP Instrument, Bending Or Contouring Orthopedic Class 1 888.4540 2016-11-17
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2019-12-12
FZS Curette, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2016-11-21
HTW Bit, Drill Orthopedic Class 1 888.4540 2016-11-17
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2018-07-05
FGN Retractor, Non-Self-Retaining Gastroenterology, Urology Class 1 876.4730 2016-11-17
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2018-04-19
JYZ Rod, Measuring Ear Ear, Nose, Throat Class 1 874.4420 2016-11-17
KAW Punch, Antrum Ear, Nose, Throat Class 1 874.4420 2016-11-16
JOL Catheter And Tip, Suction General Hospital Class 2 880.6740 2016-09-21
GDO Applier, Surgical, Clip General, Plastic Surgery Class 1 878.4800 2016-11-17
HNF Scissors, Ophthalmic Ophthalmic Class 1 886.4350 2016-11-15
NNN Crimper, Wire, Ent, Non-Sterile Ear, Nose, Throat Class 1 874.3540 2016-11-17
JZB Scissors, Ear Ear, Nose, Throat Class 1 874.4420 2016-11-21
JYY Rasp, Ear Ear, Nose, Throat Class 1 874.4420 2016-11-21
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2018-05-30
FTY Tape, Measuring, Rulers And Calipers General, Plastic Surgery Class 1 878.4800 2016-11-16
GAD Retractor General, Plastic Surgery Class 1 878.4800 2016-05-09
HWJ Awl Orthopedic Class 1 888.4540 2016-11-16
GDN Knife, Amputation General, Plastic Surgery Class 1 878.4800 2016-11-17
HWT Template Orthopedic Class 1 888.4800 2016-05-09
GFI Osteotome, Manual General, Plastic Surgery Class 1 878.4800 2016-11-16
EMJ Elevator, Surgical, Dental Dental Class 1 872.4565 2016-11-17
KAE Forceps, Ent Ear, Nose, Throat Class 1 874.4420 2016-11-16
HWI Corkscrew Orthopedic Class 1 888.4540 2016-11-17
GDG Hook, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2016-11-16
HCF Instrument, Ligature Passing And Knot Tying General, Plastic Surgery Class 1 878.4800 2016-11-17
GZX Instrument, Microsurgical Neurology Class 1 882.4525 2016-11-17
EMK Curette, Surgical, Dental Dental Class 1 872.4565 2016-11-17
NNU Scissors, Wire Cutting, Ent, Non-Sterile Ear, Nose, Throat Class 1 874.3540 2016-11-17
LYS Bone Mill Orthopedic Class 1 888.4540 2016-11-21
HDK Scissors, Episiotomy Obstetrics/Gynecology Class 1 884.4520 2016-11-21
HMR Marker, Ocular Ophthalmic Class 1 886.4570 2016-11-16
JWJ Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained Orthopedic Class 2 888.3800 2016-11-21
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2017-02-03
HRH Trephine, Manual, Ophthalmic Ophthalmic Class 1 886.4350 2016-11-16
HDF Speculum, Vaginal, Metal Obstetrics/Gynecology Class 1 884.4520 2016-11-16
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2018-03-04
KDG Chisel (Osteotome) General, Plastic Surgery Class 1 878.4820 2016-11-21
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2016-09-21
HTD Forceps General, Plastic Surgery Class 1 878.4800 2016-09-21
HTZ Instrument, Cutting, Orthopedic General, Plastic Surgery Class 1 878.4800 2016-11-21
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2018-02-19
EML Chisel, Bone, Surgical Dental Class 1 872.4565 2016-11-17
HAE Rongeur, Manual Neurology Class 2 882.4840 2016-09-21
FCW Light Source, Fiberoptic, Routine Gastroenterology, Urology Class 2 876.1500 2018-09-25
EIL Gauge, Depth, Instrument, Dental Dental Class 1 872.4565 2016-11-17
JYR Nipper, Malleus Ear, Nose, Throat Class 1 874.4420 2016-11-17
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2018-05-23
HDJ Scissors, Umbilical Obstetrics/Gynecology Class 1 884.4520 2016-11-17
HXD Clamp General, Plastic Surgery Class 1 878.4800 2016-11-21
FTX Mirror, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2016-11-17
HOE Caliper, Ophthalmic Ophthalmic Class 1 886.4350 2016-11-16
JYF Clamp, Ossicle Holding Ear, Nose, Throat Class 1 874.4420 2016-11-21
HMX Cannula, Ophthalmic Ophthalmic Class 1 886.4350 2016-11-16
HNX Depressor, Orbital Ophthalmic Class 1 886.4350 2016-11-17
JZF Tube, Ear Suction Ear, Nose, Throat Class 1 874.4420 2016-11-16
HNL Probe, Lachrymal Ophthalmic Class 1 886.4350 2016-11-16
ECP Instrument, Ligature Tucking, Orthodontic Dental Class 1 872.4565 2019-10-03
HNE Snare, Enucleating Ophthalmic Class 1 886.4350 2016-11-16
HNP Introducer, Sphere Ophthalmic Class 1 886.4350 2016-11-17
DXC Clamp, Vascular Cardiovascular Class 2 870.4450 2016-11-17
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2019-05-07
FHN Ligator, Hemorrhoidal Gastroenterology, Urology Class 2 876.4400 2016-09-21
HNY Cystotome Ophthalmic Class 1 886.4350 2016-11-16
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2016-09-21
HNK Probe, Trabeculotomy Ophthalmic Class 1 886.4350 2016-11-16
EYR Tourniquet, Gastro-Urology General, Plastic Surgery Class 1 878.5900 2016-11-17
KBS Punch, Adenoid Ear, Nose, Throat Class 1 874.4420 2016-11-21
JYT Pick, Microsurgical Ear Ear, Nose, Throat Class 1 874.4420 2016-11-21
GAF Spatula, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2016-11-17
HXW Bender Orthopedic Class 1 888.4540 2016-11-21
HOY Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) Ophthalmic Class 1 886.4750 2016-11-21
NNR Block, Cutting, Ent, Non-Sterile Ear, Nose, Throat Class 1 874.3540 2016-11-17
EIG Retractor, All Types Dental Class 1 872.4565 2016-11-17
KBE Snare, Nasal Ear, Nose, Throat Class 1 874.4420 2016-11-21
HCD Cannula, Ventricular Neurology Class 1 882.4060 2021-05-14
KAJ Mobilizer, Ent Ear, Nose, Throat Class 1 874.4420 2016-11-17
EMM Chisel, Osteotome, Surgical Dental Class 1 872.4565 2016-11-17
JYQ Loop, Wire Ear, Nose, Throat Class 1 874.4420 2016-11-17
HXG Tamp Orthopedic Class 1 888.4540 2016-11-16
HRX Arthroscope Orthopedic Class 2 888.1100 2016-11-21
HHF Remover, Intrauterine Device, Contraceptive, Hook-Type Obstetrics/Gynecology Class 1 884.4530 2016-11-21
FFO Retractor, Self-Retaining Gastroenterology, Urology Class 1 876.4730 2016-11-16
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2021-07-02
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2018-01-16
KCH Hook, Tracheal Ear, Nose, Throat Class 1 874.4420 2016-11-21
BWB Forceps, Tube Introduction Anesthesiology Class 1 868.5780 2016-11-21
KBD Scissors, Nasal Ear, Nose, Throat Class 1 874.4420 2016-11-21
HWL Set, Hollow Mill Orthopedic Class 1 888.4540 2017-04-21
CCW Laryngoscope, Rigid Anesthesiology Class 1 868.5540 2018-01-26
KAI Mirror, Ent Ear, Nose, Throat Class 1 874.4420 2016-11-17
DWP Dilator, Vessel, Surgical Cardiovascular Class 2 870.4475 2016-09-21
HAE Rongeur, Manual Neurology Class 2 882.4840 2019-10-24
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2016-09-21
HTD Forceps General, Plastic Surgery Class 1 878.4800 2016-09-21
HDA Forceps, Obstetrical Obstetrics/Gynecology Class 2 884.4400 2016-09-21
HXK Holder, Needle; Orthopedic Orthopedic Class 1 888.4540 2016-11-17
JDW Pin, Fixation, Threaded Orthopedic Class 2 888.3040 2016-11-17
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2016-11-17
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2017-12-11
KIK Hook, Bone General, Plastic Surgery Class 1 878.4800 2016-11-21
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2016-05-09
HTR Rasp General, Plastic Surgery Class 1 878.4800 2018-03-28
EMF Knife, Surgical General, Plastic Surgery Class 1 878.4800 2016-11-17
EMI File, Bone, Surgical Dental Class 1 872.4565 2016-11-16
JYG Curette, Ear Ear, Nose, Throat Class 1 874.4420 2016-11-21
EOB Nasopharyngoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4760 2016-11-21
JYJ Gauge, Measuring Ear, Nose, Throat Class 1 874.4420 2016-11-17
KBH Adenotome Ear, Nose, Throat Class 1 874.4420 2016-11-21
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2019-08-22
HFB Forceps, Biopsy, Gynecological Obstetrics/Gynecology Class 1 884.4530 2016-11-16
HGC Clamp, Uterine Obstetrics/Gynecology Class 1 884.4520 2016-11-21
GEG Elevator, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2016-11-16
FST Light, Surgical, Fiberoptic General, Plastic Surgery Class 2 878.4580 2018-03-04
GEJ Carrier, Ligature General, Plastic Surgery Class 1 878.4800 2016-11-17
GAH Stylet, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2016-11-21
EJI Syringe, Cartridge Dental Class 2 872.6770 2018-05-30
GAI Stripper, Vein, Reusable General, Plastic Surgery Class 1 878.4800 2018-05-30
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2019-03-29
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2019-03-29
JYE Chisel, Middle-Ear Ear, Nose, Throat Class 1 874.4420 2016-11-21
HNJ Punch, Corneo-Scleral Ophthalmic Class 1 886.4350 2016-11-16
HWA Impactor Orthopedic Class 1 888.4540 2016-11-16
GEN Forceps, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2016-11-16
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2016-09-21
HDQ Dilator, Cervical, Fixed Size Obstetrics/Gynecology Class 1 884.4530 2016-11-17
KBL Depressor, Metal Tongue, Surgical Ear, Nose, Throat Class 1 874.4420 2016-11-21
KAQ Gouge, Nasal, Ent Ear, Nose, Throat Class 1 874.4420 2016-11-21
KTG Knife, Ent Ear, Nose, Throat Class 1 874.4420 2016-11-16
KAP Curette, Nasal Ear, Nose, Throat Class 1 874.4420 2016-11-17
FGM Probe And Director, Gastro-Urology Gastroenterology, Urology Class 1 876.4730 2018-05-30
GDM Needle, Aspiration And Injection, Reusable General, Plastic Surgery Class 1 878.4800 2016-11-16
HNW Dilator, Lachrymal Ophthalmic Class 1 886.4350 2016-11-16
KBN Gag, Mouth Ear, Nose, Throat Class 1 874.4420 2016-11-17
HRT Stripper, Surgical Orthopedic Class 1 888.4540 2016-11-17
FHQ Holder, Needle, Gastroenterologic Gastroenterology, Urology Class 1 876.4730 2016-11-16
KBA Rasp, Nasal Ear, Nose, Throat Class 1 874.4420 2016-11-16
HNA Spud, Ophthalmic Ophthalmic Class 1 886.4350 2016-11-17
HXZ Cutter, Wire Orthopedic Class 1 888.4540 2016-11-16
HAS Needle, Neurosurgical Suture Neurology Class 1 882.4650 2016-11-17
GDI Dissector, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2016-11-21
NBH Accessories, Arthroscopic Orthopedic Class 1 888.1100 2018-04-04
GDL Needle, Suturing, Reusable General, Plastic Surgery Class 1 878.4800 2016-11-21
EKD Instrument, Cutting, Operative Dental Class 1 872.4565 2016-11-17
HHM Sound, Uterine Obstetrics/Gynecology Class 1 884.4530 2016-11-21
LRY Punch, Surgical General, Plastic Surgery Class 1 878.4800 2016-11-21
FFQ Speculum, Rectal Gastroenterology, Urology Class 1 876.4730 2018-03-26

Official Correspondent

Heidi Funston

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

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Other Registrations for Same Entity

Registration Number Establishment Name Location
8010372 Instrumed GmbH dba Avalign German Specialty Instruments TUTTLINGEN Baden-Wurttemberg, DE
1527105 AVALIGN INTEGRATED MEDICAL SOLUTIONS, INC Mentor, OH, US
3004215117 MILLENNIUM SURGICAL CORP Schaumburg, IL, US
3008864603 AVALIGN TECHNOLOGIES, Inc. Fort Wayne, IN, US

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1421101. Last updated year: 2026. Please use registration number 1421101 when referencing this establishment in official correspondence.
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