FDA Registration
Active
🇺🇸 United States
Instrumed International Inc dba Avalign German Specialty Instruments
Reg #: 1421101
·
FEI: 1421101
·
Expires 2026
Products
241
Proprietary Names
0
Establishment Types
2
Classifications
241
Registration Details
- Registration Name
- Instrumed International Inc dba Avalign German Specialty Instruments
- Registration Number
- 1421101
- FEI Number
- 1421101
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 626 Cooper Ct
- City
- SCHAUMBURG
- State
- IL
- ZIP
- 60173
- Country
- US
Regulatory Submissions
- 510(k) Number
- K971996
Owner / Operator
- Firm Name
- Avalign Technologies
- Operator Number
- 10051835
- Address
- 110275 W. Higgins Rd, Suite 920
- City
- Rosemont
- State
- IL
- Postal Code
- 60018
- Country
- US
- Correspondent
- Heidi Funston
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Needle, Ophthalmic Suturing | HNM | Class 1 | Ophthalmic | No | 2016-11-21 |
| Needle, Gastro-Urology | FHR | Class 1 | General, Plastic Surgery | No | 2016-11-17 |
| Specula Accessories | FXG | Class 1 | General, Plastic Surgery | No | 2016-11-17 |
| Irrigator, Sinus | KAR | Class 1 | Ear, Nose, Throat | No | 2016-11-21 |
| Tube, Tonsil Suction | KCB | Class 1 | Ear, Nose, Throat | No | 2016-11-16 |
| Mallet, Surgical, General & Plastic Surgery | GFJ | Class 1 | General, Plastic Surgery | No | 2016-11-16 |
| Excavator, Ear | JYH | Class 1 | Ear, Nose, Throat | No | 2016-11-21 |
| Clamp, Non-Electrical | FFN | Class 1 | Gastroenterology, Urology | No | 2016-11-21 |
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2018-02-19 |
| Saw, Manual And Accessories | GDR | Class 1 | General, Plastic Surgery | No | 2016-11-17 |
| Forceps, Tooth Extractor, Surgical | EMG | Class 1 | Dental | No | 2016-11-21 |
| Knife, Ophthalmic | HNN | Class 1 | Ophthalmic | No | 2016-11-16 |
| Cutter, Surgical | FZT | Class 1 | General, Plastic Surgery | No | 2016-11-21 |
| Probe | HXB | Class 1 | Orthopedic | No | 2016-11-17 |
| Pliers, Operative | EJY | Class 1 | Dental | No | 2016-11-17 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2016-11-17 |
| Forceps, Ophthalmic | HNR | Class 1 | Ophthalmic | No | 2016-11-15 |
| Bar, Preformed | EHO | Class 1 | Dental | No | 2016-11-17 |
| Hook, Tonsil Suturing | KBP | Class 1 | Ear, Nose, Throat | No | 2016-11-21 |
| Speculum, Ent | EPY | Class 1 | General, Plastic Surgery | No | 2016-11-17 |
| Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | HRY | Class 2 | Orthopedic | No | 2020-03-11 |
| Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | HSX | Class 2 | Orthopedic | No | 2020-03-11 |
| Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | NPJ | Class 2 | Orthopedic | No | 2020-03-11 |
| Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer | KRR | Class 2 | Orthopedic | No | 2020-03-11 |
| Hook, Ophthalmic | HNQ | Class 1 | Ophthalmic | No | 2016-11-16 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2018-03-18 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2016-11-17 |
| Instruments, Surgical, Cardiovascular | DWS | Class 1 | Cardiovascular | No | 2016-11-16 |
| Scissors, Orthopedic, Surgical | HRR | Class 1 | Orthopedic | No | 2016-11-17 |
| Coagulator-Cutter, Endoscopic, Bipolar (And Accessories) | HIN | Class 2 | Obstetrics/Gynecology | No | 2018-01-30 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2018-09-20 |
| Knife, Orthopedic | HTS | Class 1 | Orthopedic | No | 2016-11-21 |
| Cannula, Surgical, General & Plastic Surgery | GEA | Class 1 | General, Plastic Surgery | No | 2016-11-16 |
| Probe, Ent | KAK | Class 1 | Ear, Nose, Throat | No | 2016-11-16 |
| Spatula, Ophthalmic | HND | Class 1 | Ophthalmic | No | 2016-11-16 |
| Curette, Endodontic | EKT | Class 1 | Dental | No | 2016-11-17 |
| Fork, Tuning | GWX | Class 1 | Neurology | No | 2016-11-21 |
| Tonsillectome | KCA | Class 1 | Ear, Nose, Throat | No | 2016-11-21 |
| Curette, Uterine | HCY | Class 1 | Obstetrics/Gynecology | No | 2016-11-21 |
| Trocar, Ent | KTE | Class 1 | Ear, Nose, Throat | No | 2016-11-16 |
| Retractor, Ophthalmic | HNI | Class 1 | Ophthalmic | No | 2016-11-16 |
| Curette | HTF | Class 1 | General, Plastic Surgery | No | 2016-11-16 |
| Clamp, Surgical, General & Plastic Surgery | GDJ | Class 1 | General, Plastic Surgery | No | 2016-11-17 |
| Snare, Tonsil | KBZ | Class 1 | Ear, Nose, Throat | No | 2016-11-17 |
| Handle, Instrument, Dental | EJB | Class 1 | Dental | No | 2016-11-17 |
| Locator, Magnetic | FTZ | Class 1 | Ophthalmic | No | 2018-05-30 |
| Rasp, Surgical, General & Plastic Surgery | GAC | Class 1 | General, Plastic Surgery | No | 2016-05-09 |
| Clamp, Vascular | DXC | Class 2 | Cardiovascular | No | 2016-09-21 |
| Retractor, Self-Retaining, For Neurosurgery | GZT | Class 2 | Neurology | No | 2016-09-22 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2016-11-21 |
| Hook, Microsurgical Ear | JYL | Class 1 | Ear, Nose, Throat | No | 2016-11-21 |
| Instrument, Bending Or Contouring | HXP | Class 1 | Orthopedic | No | 2016-11-17 |
| Indicator, Physical/Chemical Sterilization Process | JOJ | Class 2 | General Hospital | No | 2019-12-12 |
| Curette, Surgical, General Use | FZS | Class 1 | General, Plastic Surgery | No | 2016-11-21 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2016-11-17 |
| Retractor, Non-Self-Retaining | FGN | Class 1 | Gastroenterology, Urology | No | 2016-11-17 |
| Rod, Measuring Ear | JYZ | Class 1 | Ear, Nose, Throat | No | 2016-11-17 |
| Punch, Antrum | KAW | Class 1 | Ear, Nose, Throat | No | 2016-11-16 |
| Catheter And Tip, Suction | JOL | Class 2 | General Hospital | No | 2016-09-21 |
| Applier, Surgical, Clip | GDO | Class 1 | General, Plastic Surgery | No | 2016-11-17 |
| Scissors, Ophthalmic | HNF | Class 1 | Ophthalmic | No | 2016-11-15 |
| Crimper, Wire, Ent, Non-Sterile | NNN | Class 1 | Ear, Nose, Throat | No | 2016-11-17 |
| Scissors, Ear | JZB | Class 1 | Ear, Nose, Throat | No | 2016-11-21 |
| Rasp, Ear | JYY | Class 1 | Ear, Nose, Throat | No | 2016-11-21 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 2016-11-16 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2016-05-09 |
| Awl | HWJ | Class 1 | Orthopedic | No | 2016-11-16 |
| Knife, Amputation | GDN | Class 1 | General, Plastic Surgery | No | 2016-11-17 |
| Template | HWT | Class 1 | Orthopedic | No | 2016-05-09 |
| Osteotome, Manual | GFI | Class 1 | General, Plastic Surgery | No | 2016-11-16 |
| Elevator, Surgical, Dental | EMJ | Class 1 | Dental | No | 2016-11-17 |
| Forceps, Ent | KAE | Class 1 | Ear, Nose, Throat | No | 2016-11-16 |
| Corkscrew | HWI | Class 1 | Orthopedic | No | 2016-11-17 |
| Hook, Surgical, General & Plastic Surgery | GDG | Class 1 | General, Plastic Surgery | No | 2016-11-16 |
| Instrument, Ligature Passing And Knot Tying | HCF | Class 1 | General, Plastic Surgery | No | 2016-11-17 |
| Instrument, Microsurgical | GZX | Class 1 | Neurology | No | 2016-11-17 |
| Curette, Surgical, Dental | EMK | Class 1 | Dental | No | 2016-11-17 |
| Scissors, Wire Cutting, Ent, Non-Sterile | NNU | Class 1 | Ear, Nose, Throat | No | 2016-11-17 |
| Bone Mill | LYS | Class 1 | Orthopedic | No | 2016-11-21 |
| Scissors, Episiotomy | HDK | Class 1 | Obstetrics/Gynecology | No | 2016-11-21 |
| Marker, Ocular | HMR | Class 1 | Ophthalmic | No | 2016-11-16 |
| Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained | JWJ | Class 2 | Orthopedic | No | 2016-11-21 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2017-02-03 |
| Trephine, Manual, Ophthalmic | HRH | Class 1 | Ophthalmic | No | 2016-11-16 |
| Speculum, Vaginal, Metal | HDF | Class 1 | Obstetrics/Gynecology | No | 2016-11-16 |
| Chisel (Osteotome) | KDG | Class 1 | General, Plastic Surgery | No | 2016-11-21 |
| Instrument, Cutting, Orthopedic | HTZ | Class 1 | General, Plastic Surgery | No | 2016-11-21 |
| Chisel, Bone, Surgical | EML | Class 1 | Dental | No | 2016-11-17 |
| Rongeur, Manual | HAE | Class 2 | Neurology | No | 2016-09-21 |
| Light Source, Fiberoptic, Routine | FCW | Class 2 | Gastroenterology, Urology | No | 2018-09-25 |
| Gauge, Depth, Instrument, Dental | EIL | Class 1 | Dental | No | 2016-11-17 |
| Nipper, Malleus | JYR | Class 1 | Ear, Nose, Throat | No | 2016-11-17 |
| Scissors, Umbilical | HDJ | Class 1 | Obstetrics/Gynecology | No | 2016-11-17 |
| Clamp | HXD | Class 1 | General, Plastic Surgery | No | 2016-11-21 |
| Mirror, General & Plastic Surgery | FTX | Class 1 | General, Plastic Surgery | No | 2016-11-17 |
| Caliper, Ophthalmic | HOE | Class 1 | Ophthalmic | No | 2016-11-16 |
| Clamp, Ossicle Holding | JYF | Class 1 | Ear, Nose, Throat | No | 2016-11-21 |
| Cannula, Ophthalmic | HMX | Class 1 | Ophthalmic | No | 2016-11-16 |
| Depressor, Orbital | HNX | Class 1 | Ophthalmic | No | 2016-11-17 |
| Tube, Ear Suction | JZF | Class 1 | Ear, Nose, Throat | No | 2016-11-16 |
| Probe, Lachrymal | HNL | Class 1 | Ophthalmic | No | 2016-11-16 |
| Instrument, Ligature Tucking, Orthodontic | ECP | Class 1 | Dental | No | 2019-10-03 |
| Snare, Enucleating | HNE | Class 1 | Ophthalmic | No | 2016-11-16 |
| Introducer, Sphere | HNP | Class 1 | Ophthalmic | No | 2016-11-17 |
| Ligator, Hemorrhoidal | FHN | Class 2 | Gastroenterology, Urology | No | 2016-09-21 |
| Cystotome | HNY | Class 1 | Ophthalmic | No | 2016-11-16 |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | Class 2 | General Hospital | No | 2016-09-21 |
| Probe, Trabeculotomy | HNK | Class 1 | Ophthalmic | No | 2016-11-16 |
| Tourniquet, Gastro-Urology | EYR | Class 1 | General, Plastic Surgery | No | 2016-11-17 |
| Punch, Adenoid | KBS | Class 1 | Ear, Nose, Throat | No | 2016-11-21 |
| Pick, Microsurgical Ear | JYT | Class 1 | Ear, Nose, Throat | No | 2016-11-21 |
| Spatula, Surgical, General & Plastic Surgery | GAF | Class 1 | General, Plastic Surgery | No | 2016-11-17 |
| Bender | HXW | Class 1 | Orthopedic | No | 2016-11-21 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | Class 1 | Ophthalmic | No | 2016-11-21 |
| Block, Cutting, Ent, Non-Sterile | NNR | Class 1 | Ear, Nose, Throat | No | 2016-11-17 |
| Retractor, All Types | EIG | Class 1 | Dental | No | 2016-11-17 |
| Snare, Nasal | KBE | Class 1 | Ear, Nose, Throat | No | 2016-11-21 |
| Cannula, Ventricular | HCD | Class 1 | Neurology | No | 2021-05-14 |
| Mobilizer, Ent | KAJ | Class 1 | Ear, Nose, Throat | No | 2016-11-17 |
| Chisel, Osteotome, Surgical | EMM | Class 1 | Dental | No | 2016-11-17 |
| Loop, Wire | JYQ | Class 1 | Ear, Nose, Throat | No | 2016-11-17 |
| Tamp | HXG | Class 1 | Orthopedic | No | 2016-11-16 |
| Remover, Intrauterine Device, Contraceptive, Hook-Type | HHF | Class 1 | Obstetrics/Gynecology | No | 2016-11-21 |
| Retractor, Self-Retaining | FFO | Class 1 | Gastroenterology, Urology | No | 2016-11-16 |
| Hook, Tracheal | KCH | Class 1 | Ear, Nose, Throat | No | 2016-11-21 |
| Forceps, Tube Introduction | BWB | Class 1 | Anesthesiology | No | 2016-11-21 |
| Scissors, Nasal | KBD | Class 1 | Ear, Nose, Throat | No | 2016-11-21 |
| Set, Hollow Mill | HWL | Class 1 | Orthopedic | No | 2017-04-21 |
| Laryngoscope, Rigid | CCW | Class 1 | Anesthesiology | No | 2018-01-26 |
| Mirror, Ent | KAI | Class 1 | Ear, Nose, Throat | No | 2016-11-17 |
| Dilator, Vessel, Surgical | DWP | Class 2 | Cardiovascular | No | 2016-09-21 |
| Forceps, Obstetrical | HDA | Class 2 | Obstetrics/Gynecology | No | 2016-09-21 |
| Holder, Needle; Orthopedic | HXK | Class 1 | Orthopedic | No | 2016-11-17 |
| Pin, Fixation, Threaded | JDW | Class 2 | Orthopedic | No | 2016-11-17 |
| Pin, Fixation, Smooth | HTY | Class 2 | Orthopedic | No | 2016-11-17 |
| Hook, Bone | KIK | Class 1 | General, Plastic Surgery | No | 2016-11-21 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2016-05-09 |
| Rasp | HTR | Class 1 | General, Plastic Surgery | No | 2018-03-28 |
| Knife, Surgical | EMF | Class 1 | General, Plastic Surgery | No | 2016-11-17 |
| File, Bone, Surgical | EMI | Class 1 | Dental | No | 2016-11-16 |
| Curette, Ear | JYG | Class 1 | Ear, Nose, Throat | No | 2016-11-21 |
| Nasopharyngoscope (Flexible Or Rigid) | EOB | Class 2 | Ear, Nose, Throat | No | 2016-11-21 |
| Gauge, Measuring | JYJ | Class 1 | Ear, Nose, Throat | No | 2016-11-17 |
| Adenotome | KBH | Class 1 | Ear, Nose, Throat | No | 2016-11-21 |
| Forceps, Biopsy, Gynecological | HFB | Class 1 | Obstetrics/Gynecology | No | 2016-11-16 |
| Clamp, Uterine | HGC | Class 1 | Obstetrics/Gynecology | No | 2016-11-21 |
| Elevator, Surgical, General & Plastic Surgery | GEG | Class 1 | General, Plastic Surgery | No | 2016-11-16 |
| Light, Surgical, Fiberoptic | FST | Class 2 | General, Plastic Surgery | No | 2018-03-04 |
| Carrier, Ligature | GEJ | Class 1 | General, Plastic Surgery | No | 2016-11-17 |
| Stylet, Surgical, General & Plastic Surgery | GAH | Class 1 | General, Plastic Surgery | No | 2016-11-21 |
| Syringe, Cartridge | EJI | Class 2 | Dental | No | 2018-05-30 |
| Stripper, Vein, Reusable | GAI | Class 1 | General, Plastic Surgery | No | 2018-05-30 |
| Chisel, Middle-Ear | JYE | Class 1 | Ear, Nose, Throat | No | 2016-11-21 |
| Punch, Corneo-Scleral | HNJ | Class 1 | Ophthalmic | No | 2016-11-16 |
| Impactor | HWA | Class 1 | Orthopedic | No | 2016-11-16 |
| Forceps, General & Plastic Surgery | GEN | Class 1 | General, Plastic Surgery | No | 2016-11-16 |
| Dilator, Cervical, Fixed Size | HDQ | Class 1 | Obstetrics/Gynecology | No | 2016-11-17 |
| Depressor, Metal Tongue, Surgical | KBL | Class 1 | Ear, Nose, Throat | No | 2016-11-21 |
| Gouge, Nasal, Ent | KAQ | Class 1 | Ear, Nose, Throat | No | 2016-11-21 |
| Knife, Ent | KTG | Class 1 | Ear, Nose, Throat | No | 2016-11-16 |
| Curette, Nasal | KAP | Class 1 | Ear, Nose, Throat | No | 2016-11-17 |
| Probe And Director, Gastro-Urology | FGM | Class 1 | Gastroenterology, Urology | No | 2018-05-30 |
| Needle, Aspiration And Injection, Reusable | GDM | Class 1 | General, Plastic Surgery | No | 2016-11-16 |
| Dilator, Lachrymal | HNW | Class 1 | Ophthalmic | No | 2016-11-16 |
| Gag, Mouth | KBN | Class 1 | Ear, Nose, Throat | No | 2016-11-17 |
| Stripper, Surgical | HRT | Class 1 | Orthopedic | No | 2016-11-17 |
| Holder, Needle, Gastroenterologic | FHQ | Class 1 | Gastroenterology, Urology | No | 2016-11-16 |
| Rasp, Nasal | KBA | Class 1 | Ear, Nose, Throat | No | 2016-11-16 |
| Spud, Ophthalmic | HNA | Class 1 | Ophthalmic | No | 2016-11-17 |
| Cutter, Wire | HXZ | Class 1 | Orthopedic | No | 2016-11-16 |
| Needle, Neurosurgical Suture | HAS | Class 1 | Neurology | No | 2016-11-17 |
| Dissector, Surgical, General & Plastic Surgery | GDI | Class 1 | General, Plastic Surgery | No | 2016-11-21 |
| Accessories, Arthroscopic | NBH | Class 1 | Orthopedic | No | 2018-04-04 |
| Needle, Suturing, Reusable | GDL | Class 1 | General, Plastic Surgery | No | 2016-11-21 |
| Instrument, Cutting, Operative | EKD | Class 1 | Dental | No | 2016-11-17 |
| Sound, Uterine | HHM | Class 1 | Obstetrics/Gynecology | No | 2016-11-21 |
| Punch, Surgical | LRY | Class 1 | General, Plastic Surgery | No | 2016-11-21 |
| Speculum, Rectal | FFQ | Class 1 | Gastroenterology, Urology | No | 2018-03-26 |
| File | HTP | Class 1 | Orthopedic | No | 2016-11-21 |
| Burr, Orthopedic | HTT | Class 1 | Orthopedic | No | 2018-06-01 |
| Retractor, Ent | KAL | Class 1 | Ear, Nose, Throat | No | 2016-11-17 |
| Curette, Adenoid | KBJ | Class 1 | Ear, Nose, Throat | No | 2016-11-21 |
| Needle, Tonsil Suturing | KBR | Class 1 | Ear, Nose, Throat | No | 2016-11-17 |
| Handle, Scalpel | GDZ | Class 1 | General, Plastic Surgery | No | 2016-11-16 |
| Instrument, Ent Manual Surgical | LRC | Class 1 | Ear, Nose, Throat | No | 2016-11-17 |
| Driver, Prosthesis | HWR | Class 1 | Orthopedic | No | 2016-11-21 |
| Chisel, Surgical, Manual | FZO | Class 1 | General, Plastic Surgery | No | 2016-11-17 |
| Hammer, Surgical | FZY | Class 1 | General, Plastic Surgery | No | 2016-11-17 |
| Scissors, General, Surgical | LRW | Class 1 | General, Plastic Surgery | No | 2016-11-16 |
| Forceps, Surgical, Gynecological | HCZ | Class 2 | Obstetrics/Gynecology | No | 2016-09-21 |
| Instrument, Compression | HWN | Class 1 | Orthopedic | No | 2018-01-30 |
| Instrument, Cast Application/Removal, Manual | LGG | Class 1 | Orthopedic | No | 2016-11-16 |
| Mirror, Mouth | EAX | Class 1 | Dental | No | 2016-11-17 |
| Retractor, Vaginal | HDL | Class 1 | Obstetrics/Gynecology | No | 2016-11-17 |
| Gouge, Surgical, General & Plastic Surgery | GDH | Class 1 | General, Plastic Surgery | No | 2016-11-16 |
| Knife, Nasal | KAS | Class 1 | Ear, Nose, Throat | No | 2016-11-17 |
| Passer | HWQ | Class 1 | Orthopedic | No | 2016-11-21 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2017-03-13 |
| Source, Carrier, Fiberoptic Light | EQH | Class 1 | Ear, Nose, Throat | No | 2019-01-30 |
| Ring, Ophthalmic (Flieringa) | HNH | Class 1 | Ophthalmic | No | 2016-11-17 |
| Hemostat | HRQ | Class 1 | General, Plastic Surgery | No | 2016-11-16 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2016-11-21 |
| Brace, Drill | HXY | Class 1 | Orthopedic | No | 2016-11-17 |
| Urethrotome | EZO | Class 2 | Gastroenterology, Urology | No | 2020-11-20 |
| Specula, Ophthalmic | HNC | Class 1 | Ophthalmic | No | 2016-11-17 |
| Sound, Urethral, Metal Or Plastic | FBX | Class 1 | Gastroenterology, Urology | No | 2018-05-30 |
| Instruments, Dental Hand | DZN | Class 1 | Dental | No | 2016-11-17 |
| Caliper | KTZ | Class 1 | Orthopedic | No | 2016-11-21 |
| Knife, Tonsil | KBQ | Class 1 | Ear, Nose, Throat | No | 2018-05-18 |
| Curette, Ophthalmic | HNZ | Class 1 | Ophthalmic | No | 2016-11-16 |
| Splint, Hand, And Components | ILH | Class 1 | Physical Medicine | No | 2016-11-17 |
| Speculum, Non-Illuminated | FXE | Class 1 | General, Plastic Surgery | No | 2016-11-17 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2016-11-17 |
| Clamp, Muscle, Ophthalmic | HOB | Class 1 | Ophthalmic | No | 2016-11-17 |
| Instrument, Surgical, Non-Powered | HAO | Class 1 | Neurology | No | 2016-11-16 |
| Knife, Laryngeal | JZY | Class 1 | Ear, Nose, Throat | No | 2016-11-21 |
| Goniometer, Nonpowered | KQW | Class 1 | Orthopedic | No | 2016-11-21 |
| Hook, Fibroid, Gynecological | HDE | Class 1 | Obstetrics/Gynecology | No | 2016-11-17 |
| Elevator, Ent | KAD | Class 1 | Ear, Nose, Throat | No | 2016-11-21 |
| Pusher, Band, Orthodontic | ECS | Class 1 | Dental | No | 2018-05-30 |
| Rongeur | HTX | Class 1 | Orthopedic | No | 2016-11-16 |
| Osteotome | HWM | Class 1 | General, Plastic Surgery | No | 2016-11-17 |
| Forceps, Rongeur, Surgical | EMH | Class 1 | Dental | No | 2016-11-21 |
| Twister, Wire | HXS | Class 1 | Orthopedic | No | 2016-11-17 |
| Fork | HXE | Class 1 | Orthopedic | No | 2016-11-21 |
| Rongeur, Nasal | KBB | Class 1 | Ear, Nose, Throat | No | 2016-11-21 |
| Snare, Ear | JZD | Class 1 | Ear, Nose, Throat | No | 2016-11-17 |
| Chisel, Nasal | KAN | Class 1 | General, Plastic Surgery | No | 2016-11-17 |
| Marker, Skin | FZZ | Class 1 | General, Plastic Surgery | No | 2016-11-21 |
| Extractor | HWB | Class 1 | Orthopedic | No | 2016-11-16 |
| Punch, Ent | KTF | Class 1 | Ear, Nose, Throat | No | 2016-11-16 |
| Surgical Instruments, G-U, Manual (And Accessories) | KOA | Class 1 | Gastroenterology, Urology | No | 2016-11-17 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2016-11-21 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2016-11-21 |
| Forceps, Dressing, Dental | EFL | Class 1 | Dental | No | 2016-11-17 |
| Scoop | FHL | Class 1 | Gastroenterology, Urology | No | 2018-07-25 |
| Pliers, Surgical | HTC | Class 1 | General, Plastic Surgery | No | 2016-11-16 |
| Tap, Bone | HWX | Class 1 | Orthopedic | No | 2016-11-21 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2016-11-17 |
| Curette, Ethmoid | KAO | Class 1 | Ear, Nose, Throat | No | 2016-11-17 |
| Sound, Metal, Interconnected | FBS | Class 1 | Gastroenterology, Urology | No | 2016-11-17 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Repack or Relabel Medical Device