Data / Medical devices / United States / HNM Medical dba HNM TOTAL RECON
HNM Medical dba HNM TOTAL RECON: FDA-registered device maker in Miami, FL, United States, 45 510(k) clearances
HNM Medical dba HNM TOTAL RECON is registered with the FDA (registration 3009513193) in Miami, FL, United States. It lists 212 device types. The FDA files 45 510(k) clearances under its listings, the newest dated August 2, 2023. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3009513193
- Address
- 20855 NE 16th Ave Ste C15, Miami, FL, United States, 33179
- Owner or operator
- HNM Medical (10049219)
- Roles
- Complaint file establishment, Repackager or relabeler
- First device listed
- April 29, 2015
- Registered through
- 2026
- Brand names listed
- HNM Medical Surgical Instrument
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Arthroscopic | NBH | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Accessory, Surgical Apparel | LYU | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Adenotome | KBH | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Applicator, Ent | KCJ | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Applier, Surgical, Clip | GDO | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Awl | HWJ | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Basin, Emesis | FNY | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Bender | HXW | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Bit, Drill | HTW | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Blade, Saw, General & Plastic Surgery, Surgical | GFA | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Blade, Scalpel | GES | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Bone Mill | LYS | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Bone Wedge | PLF | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Bougie, Urological | FAX | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Bur, Surgical, General & Plastic Surgery | GFF | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Caliper | KTZ | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Caliper, Ophthalmic | HOE | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Cannula And Trocar, Suprapubic, Non-Disposable | FBM | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Cannula, Injection | FGY | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Cannula, Manipulator/Injector, Uterine | LKF | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Cannula, Ophthalmic | HMX | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Cannula, Surgical, General & Plastic Surgery | GEA | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Carrier, Ligature | GEJ | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Catheter, Cholangiography | GBZ | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Chisel (Osteotome) | KDG | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Chisel, Nasal | KAN | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Chisel, Surgical, Manual | FZO | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Clamp | HXD | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Clamp, Penile | FHA | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Clamp, Surgical, General & Plastic Surgery | GDJ | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Countersink | HWW | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Cover, Shoe, Operating-Room | FXP | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Crimper, Wire, Ent, Non-Sterile | NNN | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Curette | HTF | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Curette, Adenoid | KBJ | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Curette, Ear | JYG | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Curette, Ethmoid | KAO | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Curette, Ophthalmic | HNZ | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Curette, Suction, Endometrial (And Accessories) | HHK | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Curette, Surgical, General Use | FZS | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Curette, Uterine | HCY | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Cutter, Surgical | FZT | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Cutter, Wire | HXZ | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Depressor, Metal Tongue, Surgical | KBL | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Depressor, Orbital | HNX | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Depressor, Tongue, Non-Surgical | FMA | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Dermatome | GFD | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Dilator, Catheter | GCC | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Dilator, Cervical, Fixed Size | HDQ | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Dilator, Esophageal, Ent | KCF | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Dilator, Lachrymal | HNW | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Dilator, Tracheal | KCG | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Dilator, Vaginal | HDX | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Dilator, Vessel, Surgical | DWP | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Dissector, Surgical, General & Plastic Surgery | GDI | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Driver, Surgical, Pin | GFC | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Electrosurgical Patient Return Electrode | ODR | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Elevator | HTE | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Elevator, Ent | KAD | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Elevator, Surgical, General & Plastic Surgery | GEG | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Excavator, Dental, Operative | EKC | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Explorer, Operative | EKB | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Extractor | HWB | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| File | HTP | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| File, Surgical, General & Plastic Surgery | GEO | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Forceps | HTD | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Forceps, Biopsy, Gynecological | HFB | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Forceps, Dressing, Dental | EFL | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Forceps, Ent | KAE | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Forceps, General & Plastic Surgery | GEN | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Forceps, Ophthalmic | HNR | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Forceps, Tooth Extractor, Surgical | EMG | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Fork | HXE | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Fork, Tuning | GWX | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Gag, Mouth | KBN | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Gauge, Depth | HTJ | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Gouge, Nasal, Ent | KAQ | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Gouge, Surgical, General & Plastic Surgery | GDH | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Guide, Drill, Ligament | LXI | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Guide, Surgical, Instrument | FZX | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Hammer, Surgical | FZY | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Handle, Scalpel | GDZ | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Handpiece (Brace), Drill | HBD | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Head, Surgical, Hammer | GFB | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Holder, Needle, Gastroenterologic | FHQ | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Holder, Needle; Orthopedic | HXK | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Holder, Speculum, Ent | KAG | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Hook, Fibroid, Gynecological | HDE | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Hook, Gastro-Urology | FHB | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Hook, Microsurgical Ear | JYL | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Hook, Ophthalmic | HNQ | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Hook, Surgical, General & Plastic Surgery | GDG | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Impactor | HWA | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Instrument, Cutting, Orthopedic | HTZ | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Instrument, Ligature Passing And Knot Tying | HCF | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Instrument, Manual, General Obstetric-Gynecologic | KOH | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Instrument, Manual, Surgical, General Use | MDM | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Instrument, Microsurgical | GZX | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Instrument, Surgical, Disposable | KDC | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Instrument, Surgical, Non-Powered | HAO | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Introducer, Sphere | HNP | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Irrigator, Sinus | KAR | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Kit, Surgical Instrument, Disposable | KDD | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Knife, Amputation | GDN | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Knife, Ent | KTG | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Knife, Ophthalmic | HNN | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Knife, Orthopedic | HTS | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Knife, Surgical | EMF | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Knife, Tonsil | KBQ | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Laryngoscope, Rigid | CCW | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Loop, Wire | JYQ | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Mallet | HXL | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Mallet, Surgical, General & Plastic Surgery | GFJ | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Marker, Skin | FZZ | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Mirror, Ent | KAI | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Mirror, General & Plastic Surgery | FTX | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Mobilizer, Ent | KAJ | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Needle, Aspiration And Injection, Disposable | GAA | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Needle, Aspiration And Injection, Reusable | GDM | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Needle, Ophthalmic Suturing | HNM | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Needle, Suturing, Disposable | GAB | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Needle, Suturing, Reusable | GDL | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Nipper, Malleus | JYR | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Osteotome | HWM | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Osteotome, Manual | GFI | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Packer, Uterine | HDM | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Passer | HWQ | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Pessary, Vaginal | HHW | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Pick, Microsurgical Ear | JYT | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Pin, Fixation, Smooth | HTY | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Pin, Fixation, Threaded | JDW | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Pinwheel | GWY | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Plate, Fixation, Bone | HRS | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Pliers, Surgical | HTC | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Probe | HXB | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Probe And Director, Gastro-Urology | FGM | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Probe, Ent | KAK | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Probe, Lachrymal | HNL | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Probe, Rectal, Non-Powered | EXX | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Prosthesis, Toe, Hemi-, Phalangeal | KWD | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Prosthesis, Wrist, Carpal Trapezium | KYI | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Punch, Adenoid | KBS | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Punch, Antrum | KAW | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Punch, Corneo-Scleral | HNJ | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Punch, Ent | KTF | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Punch, Surgical | LRY | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Rasp, Ear | JYY | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Rasp, Nasal | KBA | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Rasp, Surgical, General & Plastic Surgery | GAC | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Reamer | HTO | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Remover, Intrauterine Device, Contraceptive, Hook-Type | HHF | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Retainer, Surgical | GCZ | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Retractor | GAD | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Retractor, All Types | EIG | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Retractor, Ent | KAL | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Retractor, Non-Self-Retaining | FGN | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Retractor, Vaginal | HDL | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Ring Cutter | FNS | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Ring, Ophthalmic (Flieringa) | HNH | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Rongeur | HTX | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Rongeur, Nasal | KBB | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Saw | HSO | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Saw, Manual And Accessories | GDR | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Saw, Nasal | KBC | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Scissors, Ear | JZB | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Scissors, General, Surgical | LRW | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Scissors, Nasal | KBD | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Scissors, Ophthalmic | HNF | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Scissors, Orthopedic, Surgical | HRR | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Scissors, Umbilical | HDJ | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Screw, Fixation, Bone | HWC | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Screwdriver | HXX | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Skid, Bone | HWO | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Snare, Ear | JZD | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Snare, Enucleating | HNE | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Snare, Nasal | KBE | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Snare, Tonsil | KBZ | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Sound, Urethral, Metal Or Plastic | FBX | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Sound, Uterine | HHM | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Spatula, Ophthalmic | HND | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Spatula, Surgical, General & Plastic Surgery | GAF | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Specula, Ophthalmic | HNC | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Speculum, Ent | EPY | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Speculum, Rectal | FFQ | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Speculum, Vaginal, Metal | HDF | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Spreader, Bladder Neck | FHK | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Staple, Fixation, Bone | JDR | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Stripper, Surgical | HRT | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Stylet, Surgical, General & Plastic Surgery | GAH | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Sucker, Cardiotomy Return, Cardiopulmonary Bypass | DTS | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Suture, Nonabsorbable, Silk | GAP | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Suture, Nonabsorbable, Synthetic, Polyamide | GAR | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Suture, Nonabsorbable, Synthetic, Polyester | GAS | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Suture, Nonabsorbable, Synthetic, Polyethylene | GAT | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Suture, Nonabsorbable, Synthetic, Polypropylene | GAW | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Syringe, Ent | KCP | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Tamp | HXG | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Tap, Bone | HWX | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Tape, Measuring, Rulers And Calipers | FTY | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Tray, Surgical | LRP | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Trephine | HWK | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Trephine, Manual, Ophthalmic | HRH | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Tube, Ear Suction | JZF | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Tube, Tonsil Suction | KCB | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Twister, Wire | HXS | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Wrench | HXC | 1 | Complaint file establishment, 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 2, 2023 | K231126 | Eblator Device | GEI | Substantially Equivalent | E Surgical, LLC | accessdata.fda.gov |
| March 29, 2018 | K171624 | IXOS Radius Plate System | HRS | Substantially Equivalent | Stuckenbrock Medizintechnik GmbH | accessdata.fda.gov |
| January 12, 2018 | K171628 | HBS2 Headless Bone Screw | HWC | Substantially Equivalent | Stuckenbrock Medizintechnik GmbH | accessdata.fda.gov |
| July 24, 2017 | K163486 | DRACO Locking Bone Screws; DRACO Compression Screws; DRACO MetaFuse L Plates; DRACO MetaFuse BLP Plates; DRACO MetaFuse MTP Plates, Takú Plates, DuoTakú Plates, Open Wedge Plates, Osteoplate Plates, Plantar Plates, Calcaneus Offset Locking Plates | KTT | Substantially Equivalent | Hnm Total Recon, LLC | accessdata.fda.gov |
| June 2, 2017 | K171060 | OrthoButton AL | MBI | Substantially Equivalent | Riverpoint Medical | accessdata.fda.gov |
| July 29, 2016 | K161558 | Bovie 3.3mm Disposable Bipolar Ablator 90°, Aspirating and Non-Aspirating, Bovie 2.4mm Disposable Bipolar Ablator 55°, Non-Aspirating, Bovie 1.8mm Disposable Bipolar Ablator 60°, Non-Aspirating | GEI | Substantially Equivalent | Bovie Medical Corporation | accessdata.fda.gov |
| February 26, 2016 | K153575 | Tyber Medical Trauma Screw | HWC | Substantially Equivalent | Tyber Medical, LLC | accessdata.fda.gov |
| February 12, 2016 | K152187 | MetaFix LS Locking Screws, Merete Cannulated PCS, Merete CS Cortical Screws, Merete Cannulated HCS, DuoThread Scarf Screws and TwistCut Snap-Off Screws | HWC | Substantially Equivalent | Merete Medical GmbH | accessdata.fda.gov |
| January 15, 2016 | K152777 | Bovie Disposable Bipolar Ablator | GEI | Substantially Equivalent | Bovie Medical Corporation | accessdata.fda.gov |
| November 16, 2015 | K152255 | BoneCam Suture Anchors | MBI | Substantially Equivalent | Valeris Medical | accessdata.fda.gov |
| July 28, 2015 | K150394 | Tyber Medical Wedge System | PLF | Substantially Equivalent | Tyber Medical, LLC | accessdata.fda.gov |
| August 12, 2014 | K131407 | BAHADIR STERILIZATION TRAYS | KCT | Substantially Equivalent | Bahadir USA Corp. | accessdata.fda.gov |
| April 7, 2014 | K140069 | LOCKING BONE PLATE STYLE 14, METAFIX LOCKING SCREW 3.8, MERETE CANNULATED PCS 3.0 | HRS | Substantially Equivalent | Merete Medical GmbH | accessdata.fda.gov |
| March 20, 2014 | K133842 | TYBER MEDICAL TRAUMA SCREW | HWC | Substantially Equivalent | Tyber Medical, LLC | accessdata.fda.gov |
| March 6, 2014 | K133036 | APOLLO SUTURE ANCHOR SYSTEM AND TITAN SCREWS | MBI | Substantially Equivalent | Amendia, Inc. | accessdata.fda.gov |
| August 9, 2013 | K132226 | METAFIX BLP PLATE, SIZE 31, LEFT, METAFIX BLP PLATE, SIZE 31,RIGHT | HRS | Substantially Equivalent | Merete Medical GmbH | accessdata.fda.gov |
| August 8, 2013 | K130273 | PANPAC VAGINAL DILATORS | HDX | Substantially Equivalent | Panpac Medical Corporation | accessdata.fda.gov |
| November 27, 2012 | K120787 | MERETE LOCKING BONE PLATE SYSTEM III | HRS | Substantially Equivalent | Merete Medical GmbH | accessdata.fda.gov |
| October 30, 2012 | K121973 | BIOPRO HEMI-EDGE TOE SYSTEM | KWD | Substantially Equivalent | Biopro, Inc. | accessdata.fda.gov |
| December 15, 2011 | K102898 | BELLOTA SONOHYSTEROGRAPHY CATHETER WITH CERVICAL CONE, BELLOTA SONOHYSTEROGRAPHY CATHETER WITHOUT CERVICAL CONE | LKF | Substantially Equivalent | Panpac Medical Corporation | accessdata.fda.gov |
| May 13, 2011 | K102845 | MAHE FIXATION PLATE AND SCREW SYSTEM | HRS | Substantially Equivalent | Mahe Medical GmbH | accessdata.fda.gov |
| December 3, 2010 | K102688 | MERETE LOCKING BONE PLATE SYSTEM II | KTT | Substantially Equivalent | Merete Medical GmbH | accessdata.fda.gov |
| September 10, 2010 | K100736 | KIRSCHNER AND GUIDE WIRES | HTY | Substantially Equivalent | Smt Schilling Metalltechnik GmbH | 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 |
| July 26, 2010 | K092982 | THE PANPAC SUCTION CURETTE | HHK | Substantially Equivalent | Panpac Medical Corporation | accessdata.fda.gov |
| July 22, 2010 | K092981 | PANPAC VAGINAL PESSARY | HHW | Substantially Equivalent | Panpac Medical Corporation | accessdata.fda.gov |
| June 7, 2010 | K092983 | PANPAC HSG CATHETER SET | LKF | Substantially Equivalent | Panpac Medical Corporation | accessdata.fda.gov |
| May 10, 2010 | K100006 | HS FIBER (POLYBLEND), RIVER BOND, RIVERSILK (SILK), RIVERPRO (POLYPROPYLENE), RIVERLON (NYLON) MODEL VERIES BY SIZE/NEED | GAT | Substantially Equivalent | Riverpoint Medical | accessdata.fda.gov |
| March 11, 2010 | K092980 | PANPAC UTERINE MANIPULATOR INJECTOR, MODEL UMI 4.5 | LKF | Substantially Equivalent | Panpac Medical Corporation | accessdata.fda.gov |
| December 4, 2009 | K091672 | DISPOSABLE GROUNDING PAD SERIES AND ELECTRODE SERIES | GEI | Substantially Equivalent | Shuyou Electric Medical Science Co., Ltd. | accessdata.fda.gov |
| April 22, 2009 | K090063 | MERETE LOCKING BONE PLATE SYSTEM | KTT | Substantially Equivalent | Merete Medical, Inc. | accessdata.fda.gov |
| July 18, 2008 | K081513 | MERETE 3.0 AND 3.5 MM LOCKING SCREWS | HWC | Substantially Equivalent | Merete Medical GmbH | accessdata.fda.gov |
| October 29, 2007 | K072298 | BIOPRO MEMORY STAPLE, MODELS 18062-18073 | JDR | Substantially Equivalent | Biopro, Inc. | accessdata.fda.gov |
| January 22, 2007 | K063487 | MERETE BLP SMALL FRAGMENT LOCKING BONE PLATE | KTT | Substantially Equivalent | Merete Medical GmbH | accessdata.fda.gov |
| August 21, 2006 | K061798 | BIOPRO MEMORY STAPLE | JDR | Substantially Equivalent | Biopro, Inc. | accessdata.fda.gov |
| June 20, 2006 | K061089 | MODULAR THUMB IMPLANT, MODELS 17600, 17601, 17602, 17603, 17596, 17597, 17598, 17599 | KYI | Substantially Equivalent | Biopro, Inc. | accessdata.fda.gov |
| November 15, 2005 | K052596 | MODULAR THUMB IMPLANT, MODELS 17065,17066,17243,17067,17199,17238,17005,17239,17006,17240,17007,17241,17500,17501,17507 | KYI | Substantially Equivalent | Biopro, Inc. | accessdata.fda.gov |
| March 14, 2005 | K050457 | MERETE METAFIX SMALL FRAGMENT BONE PLATE SYSTEM | KTT | Substantially Equivalent | Merete Medical GmbH | accessdata.fda.gov |
| November 12, 2004 | K041595 | TOE MP JOINT, MODELS 10412-10414, 14958, 14960, 1060-10062,16818,-16822,16867-16870 | KWD | Substantially Equivalent | Biopro, Inc. | accessdata.fda.gov |
| September 8, 2004 | K041936 | BIOPRO SUBTALAR IMPLANT | HWC | Substantially Equivalent | Biopro, Inc. | accessdata.fda.gov |
| August 8, 2003 | K030302 | HBS HEADLESS BONE SCREW | HWC | Substantially Equivalent | Schoening & Assoc., Inc. | accessdata.fda.gov |
| December 17, 2002 | K023986 | ARTHREX OPES ELECTRODES AND ACCESSORIES | GEI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| August 14, 1997 | K964176 | TECNO REUSABLE, ELECTROSURGICAL, BIPOLAR FORCEPS | GEI | Substantially Equivalent | Tecno Instruments (Usa), Inc. | accessdata.fda.gov |
| February 3, 1997 | K964472 | RIOPRO COBALT TRAPEZIOMETARCARPAL RESURFACING COMPONENT | KYI | Substantially Equivalent | Biologically Oriented Prostheses | accessdata.fda.gov |
| November 22, 1991 | K911378 | TOWNLEY GREAT TOE JOINT | KWD | Substantially Equivalent | Biopro, Inc. | accessdata.fda.gov |
Compare with other makers
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Updated August 2, 2023. 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.