Data / Medical devices / United States / Instrumed International Inc dba Avalign German Specialty Instruments
Instrumed International Inc dba Avalign German Specialty Instruments: FDA-registered device maker in Schaumburg, IL, United States, 45 510(k) clearances
Instrumed International Inc dba Avalign German Specialty Instruments is registered with the FDA (registration 1421101) in Schaumburg, IL, United States. It lists 241 device types. The FDA files 45 510(k) clearances under its listings, the newest dated August 6, 2020. 2 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 1421101
- Address
- 626 Cooper Ct, Schaumburg, IL, United States, 60173
- Owner or operator
- Avalign Technologies (10051835)
- Roles
- Contract manufacturer, Repackager or relabeler
- First device listed
- May 9, 2016
- Registered through
- 2027
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Arthroscopic | NBH | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Adenotome | KBH | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Applier, Surgical, Clip | GDO | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Arthroscope | HRX | 2 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Awl | HWJ | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Bar, Preformed | EHO | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Bender | HXW | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Bit, Drill | HTW | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Block, Cutting, Ent, Non-Sterile | NNR | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Bone Mill | LYS | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Brace, Drill | HXY | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Burr, Orthopedic | HTT | 1 | Repackager or relabeler | accessdata.fda.gov |
| Caliper | KTZ | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Caliper, Ophthalmic | HOE | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Cannula, Ophthalmic | HMX | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Cannula, Surgical, General & Plastic Surgery | GEA | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Cannula, Ventricular | HCD | 1 | Repackager or relabeler | accessdata.fda.gov |
| Carrier, Ligature | GEJ | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Catheter And Tip, Suction | JOL | 2 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Chisel (Osteotome) | KDG | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Chisel, Bone, Surgical | EML | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Chisel, Middle-Ear | JYE | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Chisel, Nasal | KAN | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Chisel, Osteotome, Surgical | EMM | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Chisel, Surgical, Manual | FZO | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Clamp | HXD | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Clamp, Muscle, Ophthalmic | HOB | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Clamp, Non-Electrical | FFN | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Clamp, Ossicle Holding | JYF | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Clamp, Surgical, General & Plastic Surgery | GDJ | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Clamp, Uterine | HGC | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Clamp, Vascular | DXC | 2 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Coagulator-Cutter, Endoscopic, Bipolar (And Accessories) | HIN | 2 | Repackager or relabeler | accessdata.fda.gov |
| Corkscrew | HWI | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Crimper, Wire, Ent, Non-Sterile | NNN | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Curette | HTF | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Curette, Adenoid | KBJ | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Curette, Ear | JYG | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Curette, Endodontic | EKT | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Curette, Ethmoid | KAO | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Curette, Nasal | KAP | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Curette, Ophthalmic | HNZ | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Curette, Surgical, Dental | EMK | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Curette, Surgical, General Use | FZS | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Curette, Uterine | HCY | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Cutter, Surgical | FZT | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Cutter, Wire | HXZ | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Cystotome | HNY | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Depressor, Metal Tongue, Surgical | KBL | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Depressor, Orbital | HNX | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Dilator, Cervical, Fixed Size | HDQ | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Dilator, Lachrymal | HNW | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Dilator, Vessel, Surgical | DWP | 2 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Dissector, Surgical, General & Plastic Surgery | GDI | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Driver, Prosthesis | HWR | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Elevator, Ent | KAD | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Elevator, Surgical, Dental | EMJ | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Elevator, Surgical, General & Plastic Surgery | GEG | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Excavator, Ear | JYH | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Extractor | HWB | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| File | HTP | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| File, Bone, Surgical | EMI | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Forceps | HTD | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Forceps, Biopsy, Gynecological | HFB | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Forceps, Dressing, Dental | EFL | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Forceps, Ent | KAE | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Forceps, General & Plastic Surgery | GEN | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Forceps, Obstetrical | HDA | 2 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Forceps, Ophthalmic | HNR | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Forceps, Rongeur, Surgical | EMH | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Forceps, Surgical, Gynecological | HCZ | 2 | Repackager or relabeler | accessdata.fda.gov |
| Forceps, Tooth Extractor, Surgical | EMG | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Forceps, Tube Introduction | BWB | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Fork | HXE | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Fork, Tuning | GWX | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Gag, Mouth | KBN | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Gauge, Depth | HTJ | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Gauge, Depth, Instrument, Dental | EIL | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Gauge, Measuring | JYJ | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Goniometer, Nonpowered | KQW | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Gouge, Nasal, Ent | KAQ | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Gouge, Surgical, General & Plastic Surgery | GDH | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Guide, Surgical, Instrument | FZX | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Hammer, Surgical | FZY | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Handle, Instrument, Dental | EJB | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Handle, Scalpel | GDZ | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Hemostat | HRQ | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Holder, Needle, Gastroenterologic | FHQ | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Holder, Needle; Orthopedic | HXK | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Hook, Bone | KIK | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Hook, Fibroid, Gynecological | HDE | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Hook, Microsurgical Ear | JYL | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Hook, Ophthalmic | HNQ | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Hook, Surgical, General & Plastic Surgery | GDG | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Hook, Tonsil Suturing | KBP | 1 | Contract manufacturer | accessdata.fda.gov |
| Hook, Tracheal | KCH | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Impactor | HWA | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Indicator, Physical/Chemical Sterilization Process | JOJ | 2 | Repackager or relabeler | accessdata.fda.gov |
| Instrument, Bending Or Contouring | HXP | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Instrument, Cast Application/Removal, Manual | LGG | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Instrument, Compression | HWN | 1 | Repackager or relabeler | accessdata.fda.gov |
| Instrument, Cutting, Operative | EKD | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Instrument, Cutting, Orthopedic | HTZ | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Instrument, Ent Manual Surgical | LRC | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Instrument, Ligature Passing And Knot Tying | HCF | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Instrument, Ligature Tucking, Orthodontic | ECP | 1 | Repackager or relabeler | accessdata.fda.gov |
| Instrument, Manual, Surgical, General Use | MDM | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Instrument, Microsurgical | GZX | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Instrument, Surgical, Non-Powered | HAO | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Instruments, Dental Hand | DZN | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Instruments, Surgical, Cardiovascular | DWS | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Introducer, Sphere | HNP | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Irrigator, Sinus | KAR | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Knife, Amputation | GDN | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Knife, Ent | KTG | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Knife, Laryngeal | JZY | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Knife, Nasal | KAS | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Knife, Ophthalmic | HNN | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Knife, Orthopedic | HTS | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Knife, Surgical | EMF | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Knife, Tonsil | KBQ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Laparoscope, General & Plastic Surgery | GCJ | 2 | Repackager or relabeler | accessdata.fda.gov |
| Laryngoscope, Rigid | CCW | 1 | Repackager or relabeler | accessdata.fda.gov |
| Ligator, Hemorrhoidal | FHN | 2 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Light Source, Fiberoptic, Routine | FCW | 2 | Repackager or relabeler | accessdata.fda.gov |
| Light, Surgical, Fiberoptic | FST | 2 | Repackager or relabeler | accessdata.fda.gov |
| Locator, Magnetic | FTZ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Loop, Wire | JYQ | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Mallet, Surgical, General & Plastic Surgery | GFJ | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Marker, Ocular | HMR | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Marker, Skin | FZZ | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Mirror, Ent | KAI | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Mirror, General & Plastic Surgery | FTX | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Mirror, Mouth | EAX | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Mobilizer, Ent | KAJ | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Nasopharyngoscope (Flexible Or Rigid) | EOB | 2 | Repackager or relabeler | accessdata.fda.gov |
| Needle, Aspiration And Injection, Reusable | GDM | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Needle, Gastro-Urology | FHR | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Needle, Neurosurgical Suture | HAS | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Needle, Ophthalmic Suturing | HNM | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Needle, Suturing, Reusable | GDL | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Needle, Tonsil Suturing | KBR | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Nipper, Malleus | JYR | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Orthopedic Stereotaxic Instrument | OLO | 2 | Contract manufacturer | accessdata.fda.gov |
| Osteotome | HWM | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Osteotome, Manual | GFI | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Passer | HWQ | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Pick, Microsurgical Ear | JYT | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Pin, Fixation, Smooth | HTY | 2 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Pin, Fixation, Threaded | JDW | 2 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Plate, Fixation, Bone | HRS | 2 | Contract manufacturer | accessdata.fda.gov |
| Pliers, Operative | EJY | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Pliers, Surgical | HTC | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Probe | HXB | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Probe And Director, Gastro-Urology | FGM | 1 | Repackager or relabeler | accessdata.fda.gov |
| Probe, Ent | KAK | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Probe, Lachrymal | HNL | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Probe, Trabeculotomy | HNK | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | NPJ | 2 | Repackager or relabeler | accessdata.fda.gov |
| Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | HSX | 2 | Repackager or relabeler | accessdata.fda.gov |
| Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | HRY | 2 | Repackager or relabeler | accessdata.fda.gov |
| Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer | KRR | 2 | Repackager or relabeler | accessdata.fda.gov |
| Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained | JWJ | 2 | Repackager or relabeler | accessdata.fda.gov |
| Punch, Adenoid | KBS | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Punch, Antrum | KAW | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Punch, Corneo-Scleral | HNJ | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Punch, Ent | KTF | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Punch, Surgical | LRY | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Pusher, Band, Orthodontic | ECS | 1 | Repackager or relabeler | accessdata.fda.gov |
| Rasp | HTR | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Rasp, Ear | JYY | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Rasp, Nasal | KBA | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Rasp, Surgical, General & Plastic Surgery | GAC | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Reamer | HTO | 1 | Repackager or relabeler | accessdata.fda.gov |
| Remover, Intrauterine Device, Contraceptive, Hook-Type | HHF | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Retractor | GAD | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Retractor, All Types | EIG | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Retractor, Ent | KAL | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Retractor, Non-Self-Retaining | FGN | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Retractor, Ophthalmic | HNI | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Retractor, Self-Retaining | FFO | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Retractor, Self-Retaining, For Neurosurgery | GZT | 2 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Retractor, Vaginal | HDL | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Ring, Ophthalmic (Flieringa) | HNH | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Rod, Measuring Ear | JYZ | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Rongeur | HTX | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Rongeur, Manual | HAE | 2 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Rongeur, Nasal | KBB | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Saw, Manual And Accessories | GDR | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Scissors, Ear | JZB | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Scissors, Episiotomy | HDK | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Scissors, General, Surgical | LRW | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Scissors, Nasal | KBD | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Scissors, Ophthalmic | HNF | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Scissors, Orthopedic, Surgical | HRR | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Scissors, Umbilical | HDJ | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Scissors, Wire Cutting, Ent, Non-Sterile | NNU | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Scoop | FHL | 1 | Repackager or relabeler | accessdata.fda.gov |
| Screw, Fixation, Bone | HWC | 2 | Contract manufacturer | accessdata.fda.gov |
| Screwdriver | HXX | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Set, Hollow Mill | HWL | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Snare, Ear | JZD | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Snare, Enucleating | HNE | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Snare, Nasal | KBE | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Snare, Tonsil | KBZ | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Sound, Metal, Interconnected | FBS | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Sound, Urethral, Metal Or Plastic | FBX | 1 | Repackager or relabeler | accessdata.fda.gov |
| Sound, Uterine | HHM | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Source, Carrier, Fiberoptic Light | EQH | 1 | Repackager or relabeler | accessdata.fda.gov |
| Spatula, Ophthalmic | HND | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Spatula, Surgical, General & Plastic Surgery | GAF | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Specula Accessories | FXG | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Specula, Ophthalmic | HNC | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Speculum, Ent | EPY | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Speculum, Non-Illuminated | FXE | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Speculum, Rectal | FFQ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Speculum, Vaginal, Metal | HDF | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Splint, Hand, And Components | ILH | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Spud, Ophthalmic | HNA | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | 2 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Stripper, Surgical | HRT | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Stripper, Vein, Reusable | GAI | 1 | Repackager or relabeler | accessdata.fda.gov |
| Stylet, Surgical, General & Plastic Surgery | GAH | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Surgical Instruments, G-U, Manual (And Accessories) | KOA | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Syringe, Cartridge | EJI | 2 | Repackager or relabeler | accessdata.fda.gov |
| Tamp | HXG | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Tap, Bone | HWX | 1 | Contract manufacturer | accessdata.fda.gov |
| Tape, Measuring, Rulers And Calipers | FTY | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Template | HWT | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Tonsillectome | KCA | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Tourniquet, Gastro-Urology | EYR | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Repackager or relabeler | accessdata.fda.gov |
| Trephine, Manual, Ophthalmic | HRH | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Trocar, Ent | KTE | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Tube, Ear Suction | JZF | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Tube, Tonsil Suction | KCB | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Twister, Wire | HXS | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Urethrotome | EZO | 2 | Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 6, 2020 | K193066 | Steripack cases and Tray Systems | KCT | Substantially Equivalent | Avalign Technologies, Inc. | accessdata.fda.gov |
| March 22, 2019 | K181173 | ELMED Laparoscopic Instruments and Accessories | GCJ | Substantially Equivalent | Elmed Incorporated | accessdata.fda.gov |
| April 5, 2018 | K172368 | Bipolar Micro-Coagulation Forceps | GEI | Substantially Equivalent | Gunter Bissinger Medizintechnik GmbH | accessdata.fda.gov |
| February 29, 2016 | K150468 | Laminectomy Rongeurs, Kerrison Rongeurs, IVD Rongeurs | HAE | Substantially Equivalent | K2 Medical GmbH & Co. KG | accessdata.fda.gov |
| May 10, 2013 | K123478 | STINGRAY BIPOLAR FORCEPS | GEI | Substantially Equivalent | Stingray Surgical Products | accessdata.fda.gov |
| November 9, 2011 | K102752 | STINGRAY ULTRALITE DISPOSABLE IRRIGATING BIPOLAR FORCEPS | GEI | Substantially Equivalent | Stingray Surgical Products, Inc. | accessdata.fda.gov |
| May 10, 2011 | K110121 | WEXLER ENDOSCOPE ACCESSORIES | GCJ | Substantially Equivalent | Microsurgical Laboratories,Inc.Dba Wexler Surgical | accessdata.fda.gov |
| August 31, 2010 | K100518 | INSTRUMED VESSEL DILATORS, MODEL 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054 | DWP | Substantially Equivalent | Instrumed International, Inc. | accessdata.fda.gov |
| April 29, 2010 | K100517 | INSTRUMED FORCEPS OBSTERICAL, MODEL# 46-5XXX, OB-XXXX | HDA | Substantially Equivalent | Instrumed International, Inc. | accessdata.fda.gov |
| December 3, 2009 | K092840 | INSTRUMED FORCEPS OBSTETRICAL/GYNAECOLOGICAL | HCZ | Substantially Equivalent | Instrumed International, Inc. | accessdata.fda.gov |
| October 26, 2009 | K092544 | INSTRUMED VASCULAR CLAMPS | DXC | Substantially Equivalent | Instrumed International, Inc. | accessdata.fda.gov |
| June 17, 2009 | K090763 | RESTORIS MULTICOMPARTMENTAL KNEE (MCK) SYSTEM | NPJ | Substantially Equivalent | Mako Surgical Corporation | accessdata.fda.gov |
| March 9, 2009 | K083796 | MILTEX ASPIRATING SYRINGE, MILTEX PETITE ASPIRATING SYRINGE, MILTEX SELF-ASPIRATING SYRINGE, MILTEX LIGHTWEIGHT | EJI | Substantially Equivalent | Miltex, Inc. | accessdata.fda.gov |
| January 12, 2009 | K083162 | STINGRAY ELECTROSURGICAL FORCEPS | GEI | Substantially Equivalent | Stingray Surgical Products, Inc. | accessdata.fda.gov |
| August 8, 2008 | K081651 | INSTRUMED RONGEUR | HAE | Substantially Equivalent | Instrumed International, Inc. | accessdata.fda.gov |
| August 2, 2007 | K071771 | INSTRUMED RETRACTORS | GZT | Substantially Equivalent | Instrumed International, Inc. | accessdata.fda.gov |
| July 19, 2006 | K060233 | TROKAMED GMBH ENDOSCOPES AND ACCESSORIES | GCJ | Substantially Equivalent | Trokamed GmbH | accessdata.fda.gov |
| April 16, 2004 | K040855 | INSTRUMED LAPAROSCOPE AND ACCESSORIES | GEI | Substantially Equivalent | Instrumed International, Inc. | accessdata.fda.gov |
| March 25, 2003 | K030665 | BONE WIRE | HTY | Substantially Equivalent | Stork Instrumente GmbH | accessdata.fda.gov |
| December 2, 2002 | K021859 | WRIST IMPLANT | JWJ | Substantially Equivalent | Avanta Orthopaedics, Inc. | accessdata.fda.gov |
| March 1, 2001 | K003717 | INSTRUMENTS FOR LAPAROSCOPY 5 MM, 10 MM WITH COLOURED HANDLE, DETACHABLE ENDODCOPIC INSTRUMENTS 5 MM, 10MM (HANDLE, SHAF | GEI | Substantially Equivalent | Tekno Medical Optik-Chirurgie GmbH & Co. | accessdata.fda.gov |
| April 24, 2000 | K000297 | ERCHINGER HEMORRHOIDAL LIGATORS: SUCTION LIGATORS, MOD. ERCHINGER, RUDD, MCGIVNEY MOD. ERCHINGER | FHN | Substantially Equivalent | Erchinger Medizintecnik | accessdata.fda.gov |
| August 13, 1998 | K981751 | SINUSCOPE AND ACCESSORIES | EOB | Substantially Equivalent | Henke Sass Wolf of America, Inc. | accessdata.fda.gov |
| June 24, 1998 | K974595 | CUSHING BAYONET, INSULATED BIPOLAR FORCEP | HTD | Substantially Equivalent | Titan Mfg., Inc. | accessdata.fda.gov |
| June 24, 1998 | K974594 | SEMKIN BIPOLAR FORCEP | HTD | Substantially Equivalent | Titan Mfg., Inc. | accessdata.fda.gov |
| June 24, 1998 | K974593 | SEMKIN INSULATED BIPOLAR FORCEP | HTD | Substantially Equivalent | Titan Mfg., Inc. | accessdata.fda.gov |
| June 18, 1998 | K980002 | KOALA VASCULAR CLAMPS AND INSERTS | DXC | Substantially Equivalent | Boss Instruments, Ltd. | accessdata.fda.gov |
| April 21, 1998 | K974382 | ACKERMANN SURGICAL INSTRUMENTS | GCJ | Substantially Equivalent | Ackermann Instrumente GmbH | accessdata.fda.gov |
| March 19, 1998 | K974793 | ELMED ESU 120 M/M DIGITAL | GEI | Substantially Equivalent | Elmed, Inc. | accessdata.fda.gov |
| March 18, 1998 | K972225 | UFR FIBEROPTIC CABLE | FST | Substantially Equivalent | Universal Fiberoptic Repair, Inc. | accessdata.fda.gov |
| September 19, 1997 | K972901 | AMERICAN BIOSURGICAL ELECTROSURGICAL BIPOLAR CABLE/CORD | GEI | Substantially Equivalent | American Biosurgical, Inc. | accessdata.fda.gov |
| August 14, 1997 | K964176 | TECNO REUSABLE, ELECTROSURGICAL, BIPOLAR FORCEPS | GEI | Substantially Equivalent | Tecno Instruments (Usa), Inc. | accessdata.fda.gov |
| July 31, 1997 | K971996 | MEDIVISION ARTHROSCOP | HRX | Substantially Equivalent | Medivision Scope Service Center, Inc. | accessdata.fda.gov |
| March 7, 1997 | K962545 | DENTAL, MEDICAL INSTRUMENT CASES & CASSETTE | KCT | Substantially Equivalent | Sterilization Cassette Systems, Inc. | accessdata.fda.gov |
| January 17, 1997 | K962075 | HSW GMBH ARTHROSCOPE | HRX | Substantially Equivalent | Henke Sass Wolf of America, Inc. | accessdata.fda.gov |
| October 18, 1995 | K953889 | AMERICAN BIOSURGICAL ELECTROSURGICAL BIPOLAR CABLE/CORD | GEI | Substantially Equivalent | American Biosurgical, Inc. | accessdata.fda.gov |
| November 15, 1994 | K926517 | ELMED LBC 50-P | HIN | Substantially Equivalent | Elmed, Inc. | accessdata.fda.gov |
| May 2, 1994 | K932938 | ELMED ESU 300 M/M AND DIGITAL | GEI | Substantially Equivalent | Elmed, Inc. | accessdata.fda.gov |
| May 17, 1993 | K921770 | ELECTROSURGICAL UNITS ESU 100L, 100 L M/M & E M/M | GEI | Substantially Equivalent | Elmed, Inc. | accessdata.fda.gov |
| November 5, 1992 | K915731 | ELECTROSURGICAL UNITS ESU 30, 70, 70 B, 70 DIGITAL | GEI | Substantially Equivalent | Elmed, Inc. | accessdata.fda.gov |
| May 2, 1991 | K911160 | MENTOR(R) WET-FIELD(R) II AC COAGULATOR, 22-1305 | GEI | Substantially Equivalent | Mentor O & O, Inc. | accessdata.fda.gov |
| August 7, 1989 | K890765 | STRIP, STERILIZATION INDICATOR; STEAM OR E.O. GAS | JOJ | Substantially Equivalent | Spsmedical Supply Corp. | accessdata.fda.gov |
| August 7, 1989 | K890755 | SEALING TAPE, STERILIZATION INDICATOR; STEAM | JOJ | Substantially Equivalent | Spsmedical Supply Corp. | accessdata.fda.gov |
| July 25, 1989 | K894303 | MEDSCOPE 4MM ARTHROSCOPE | HRX | Substantially Equivalent | Medscope Corp. | accessdata.fda.gov |
| April 23, 1984 | K832589 | ELMED WMC 10 AND BC 50 M/M | Substantially Equivalent | Elmed, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 8, 2014 | 69471 | Class II | Terminated | A uterine tenaculum is a hook-like instrument used to seize and hold the cervix or fundus sold under the CareFusion, Teleflex Medical, Symmetry Surgical brand names. A uterine tenaculum is a hook-like instrument used to | The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices. | accessdata.fda.gov |
| May 30, 2014 | 68725 | Class II | Terminated | Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to provide access, illuminatio | Additional caution statements have been added to the Instructions For Use for monopolar electrodes. 1) To avoid tissue carbonation, the operation voltage of the HF generator must not exceed 650 peak voltage (Vp) for all monopolar electrodes. and 2) For all monopolar electrodes, the useful life of this product is less than or equal to 50 cycles and less than | accessdata.fda.gov |
Compare with other makers
- All makers of Osteotome, Manual
- All makers of Rongeur, Manual
- All makers of Tap, Bone
- All makers of Clamp, Vascular
- All makers of Instruments, Dental Hand
- All makers of Knife, Amputation
Updated August 6, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.