Instrumed GmbH dba Avalign German Specialty Instruments

FDA Device Registration & Listing · TUTTLINGEN Baden-Wurttemberg, DE · Registration 8010372

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
8010372
FEI Number
3007290840
Entity Name
Instrumed GmbH dba Avalign German Specialty Instruments
City/State/Country
TUTTLINGEN Baden-Wurttemberg, DE
Establishment Address
3 Unter Buchsteig, TUTTLINGEN Baden-Wurttemberg 78532, DE
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Avalign Technologies (Owner Number: 10051835)
Owner / Operator Contact Address
110275 W. Higgins Rd, Suite 920, Rosemont, IL 60018, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Joint Aspiration Tray

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
JYE Chisel, Middle-Ear Ear, Nose, Throat Class 1 874.4420 2016-11-21
FGN Retractor, Non-Self-Retaining Gastroenterology, Urology Class 1 876.4730 2016-11-17
EPY Speculum, Ent General, Plastic Surgery Class 1 878.1800 2016-11-17
KTF Punch, Ent Ear, Nose, Throat Class 1 874.4420 2016-11-16
EMJ Elevator, Surgical, Dental Dental Class 1 872.4565 2016-11-17
HDQ Dilator, Cervical, Fixed Size Obstetrics/Gynecology Class 1 884.4530 2016-11-17
HXZ Cutter, Wire Orthopedic Class 1 888.4540 2016-11-16
HXB Probe Orthopedic Class 1 888.4540 2016-11-17
HXD Clamp General, Plastic Surgery Class 1 878.4800 2016-11-21
JYZ Rod, Measuring Ear Ear, Nose, Throat Class 1 874.4420 2016-11-17
GAF Spatula, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2016-11-17
GEA Cannula, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2016-11-16
EMG Forceps, Tooth Extractor, Surgical Dental Class 1 872.4565 2016-11-21
GDI Dissector, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2016-11-21
HDF Speculum, Vaginal, Metal Obstetrics/Gynecology Class 1 884.4520 2016-11-16
HFB Forceps, Biopsy, Gynecological Obstetrics/Gynecology Class 1 884.4530 2016-11-16
KTG Knife, Ent Ear, Nose, Throat Class 1 874.4420 2016-11-16
KBA Rasp, Nasal 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
HNQ Hook, Ophthalmic Ophthalmic Class 1 886.4350 2016-11-16
FTY Tape, Measuring, Rulers And Calipers General, Plastic Surgery Class 1 878.4800 2016-11-16
EHO Bar, Preformed Dental Class 1 872.3165 2016-11-17
HTD Forceps General, Plastic Surgery Class 1 878.4800 2016-11-17
FZZ Marker, Skin General, Plastic Surgery Class 1 878.4660 2016-11-21
DWS Instruments, Surgical, Cardiovascular Cardiovascular Class 1 870.4500 2016-11-16
KAK Probe, Ent Ear, Nose, Throat Class 1 874.4420 2016-11-16
NNN Crimper, Wire, Ent, Non-Sterile Ear, Nose, Throat Class 1 874.3540 2016-11-17
JZY Knife, Laryngeal Ear, Nose, Throat Class 1 874.4420 2016-11-21
HOE Caliper, Ophthalmic Ophthalmic Class 1 886.4350 2016-11-16
KAD Elevator, Ent Ear, Nose, Throat Class 1 874.4420 2016-11-21
HXS Twister, Wire Orthopedic Class 1 888.4540 2016-11-17
HNW Dilator, Lachrymal Ophthalmic Class 1 886.4350 2016-11-16
KAI Mirror, Ent Ear, Nose, Throat Class 1 874.4420 2016-11-17
FHR Needle, Gastro-Urology General, Plastic Surgery Class 1 878.4800 2016-11-17
HCF Instrument, Ligature Passing And Knot Tying General, Plastic Surgery Class 1 878.4800 2016-11-17
LRW Scissors, General, Surgical General, Plastic Surgery Class 1 878.4800 2016-11-16
HNH Ring, Ophthalmic (Flieringa) Ophthalmic Class 1 886.4350 2016-11-17
HTC Pliers, Surgical General, Plastic Surgery Class 1 878.4800 2016-11-16
KBD Scissors, Nasal Ear, Nose, Throat Class 1 874.4420 2016-11-21
JYL Hook, Microsurgical Ear Ear, Nose, Throat Class 1 874.4420 2016-11-21
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2016-11-17
HRR Scissors, Orthopedic, Surgical Orthopedic Class 1 888.4540 2016-11-17
HRQ Hemostat General, Plastic Surgery Class 1 878.4800 2016-11-16
HAS Needle, Neurosurgical Suture Neurology Class 1 882.4650 2016-11-17
KAL Retractor, Ent Ear, Nose, Throat Class 1 874.4420 2016-11-17
HTR Rasp General, Plastic Surgery Class 1 878.4800 2018-03-28
DXC Clamp, Vascular Cardiovascular Class 2 870.4450 2016-09-21
GZX Instrument, Microsurgical Neurology Class 1 882.4525 2016-11-17
JYJ Gauge, Measuring Ear, Nose, Throat Class 1 874.4420 2016-11-17
GDN Knife, Amputation General, Plastic Surgery Class 1 878.4800 2016-11-17
GDH Gouge, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2016-11-16
KBR Needle, Tonsil Suturing Ear, Nose, Throat Class 1 874.4420 2016-11-17
GEN Forceps, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2016-11-16
KAE Forceps, Ent Ear, Nose, Throat Class 1 874.4420 2016-11-16
HNN Knife, Ophthalmic Ophthalmic Class 1 886.4350 2016-11-16
FHQ Holder, Needle, Gastroenterologic Gastroenterology, Urology Class 1 876.4730 2016-11-16
HTF Curette General, Plastic Surgery Class 1 878.4800 2016-11-16
DWP Dilator, Vessel, Surgical Cardiovascular Class 2 870.4475 2016-09-21
JYY Rasp, Ear Ear, Nose, Throat Class 1 874.4420 2016-11-21
JZB Scissors, Ear Ear, Nose, Throat Class 1 874.4420 2016-11-21
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2016-05-09
EMM Chisel, Osteotome, Surgical Dental Class 1 872.4565 2016-11-17
DXC Clamp, Vascular Cardiovascular Class 2 870.4450 2016-11-17
JYC Cannula, Ear General, Plastic Surgery Class 1 878.4800 2017-01-19
OJT Aspiration Tray General, Plastic Surgery Class 1 878.4800 2020-05-28
HTW Bit, Drill Orthopedic Class 1 888.4540 2016-11-17
HWM Osteotome General, Plastic Surgery Class 1 878.4800 2016-11-17
JZF Tube, Ear Suction Ear, Nose, Throat Class 1 874.4420 2016-11-16
JYH Excavator, Ear Ear, Nose, Throat Class 1 874.4420 2016-11-21
HCZ Forceps, Surgical, Gynecological Obstetrics/Gynecology Class 2 884.4530 2016-09-21
FFO Retractor, Self-Retaining Gastroenterology, Urology Class 1 876.4730 2016-11-16
FZX Guide, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2016-11-21
KCB Tube, Tonsil Suction Ear, Nose, Throat Class 1 874.4420 2016-11-16
JYO Knife, Ear Ear, Nose, Throat Class 1 874.4420 2017-01-19

Official Correspondent

Heidi Funston

US Agent Details

Heidi Funston Business: Avalign Technologies Email: hfunston@avalign.com Phone: (260) 4841500

Related Public Records

Same Entity

Avalign Technologies
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
1527105 AVALIGN INTEGRATED MEDICAL SOLUTIONS, INC Mentor, OH, US
1421101 Instrumed International Inc dba Avalign German Specialty Instruments SCHAUMBURG, IL, US
3004215117 MILLENNIUM SURGICAL CORP Schaumburg, IL, US
3008864603 AVALIGN TECHNOLOGIES, Inc. Fort Wayne, IN, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K834189 Imm Enterprises , Ltd. JAKOBI SURG. INSTRUMENTS #7 44/47 1984-03-06
K863293 Lifestream Int'L, Inc. DISPOSABLE SUCTION CANNULA NO. 902008-000 1986-09-09
K852723 The Huxley Instrument Corp. FOERSTER SPONGE FORCEPS, SERRATED, 7+SS 410 OR 420 1985-07-15
K873512 Arthropedics, Inc. SERRATED GRASPING FORCEPS, RIGHT 1987-11-02
K851170 The Huxley Instrument Corp. DISSECTING TWEEZER #283-72PCS. SS 410 1985-04-25

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0008-04 Rultract Inc 1
Rultract Surgical Retractor, 4100 Series, all system configurations, reusable.
Z-0026-04 Surgical Specialties Corp 1
Sharpoint 2.75 mm x 3.75 mm ClearTrap Trapezoid Knife Clear Corneal Implant Angled. The product can be sold as an individual unit or in a box of 6 knives.
Z-1922-2024 Alcon Research LLC Aspex Facility 1
20 Gauge V-Lance Knife Model/Catalog Number: 8065912001 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
Z-1923-2024 Alcon Research LLC Aspex Facility 1
ClearCut Sideport Knife Dual Bevel 1.2mm Angled Model/Catalog Number: 8065921541 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A
Z-1924-2024 Alcon Research LLC Aspex Facility 1
ClearCut S Safety Sideport Knife 1.0mm Dual Bevel Model/Catalog Number: 8065771540 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8010372. Last updated year: 2026. Please use registration number 8010372 when referencing this establishment in official correspondence.
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