FDA Device Registration & Listing · Vadodara Gujarat, IN · Registration 3013846070
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| HTR | Rasp | General, Plastic Surgery | Class 1 | 878.4800 | 2025-02-26 |
| HWM | Osteotome | General, Plastic Surgery | Class 1 | 878.4800 | 2025-02-26 |
| HXP | Instrument, Bending Or Contouring | Orthopedic | Class 1 | 888.4540 | 2023-04-10 |
| BXA | Analyzer, Gas, Water Vapor, Gaseous-Phase | Anesthesiology | Class 1 | 868.1975 | 2025-12-10 |
| HDH | Needle, Cerclage, Gynecological | Obstetrics/Gynecology | Class 1 | 884.4530 | 2024-09-27 |
| OCJ | Spinal Channeling Instrument, Vertebroplasty | Orthopedic | Class 1 | 888.4540 | 2023-04-10 |
| HWB | Extractor | Orthopedic | Class 1 | 888.4540 | 2023-04-09 |
| HWQ | Passer | Orthopedic | Class 1 | 888.4540 | 2023-04-09 |
| QBV | Centrifuge For Preparation Of Cell Concentrate And/Or Plasma Concentrate | Clinical Chemistry | Class 1 | 862.2050 | 2024-08-13 |
| HXS | Twister, Wire | Orthopedic | Class 1 | 888.4540 | 2023-04-09 |
| KQW | Goniometer, Nonpowered | Orthopedic | Class 1 | 888.1520 | 2023-04-09 |
| HTT | Burr, Orthopedic | Orthopedic | Class 1 | 888.4540 | 2023-04-09 |
| IXR | Table, Radiographic, Tilting | Radiology | Class 2 | 892.1980 | 2025-03-07 |
| BYG | Mask, Oxygen | Anesthesiology | Class 1 | 868.5580 | 2024-09-27 |
| HXB | Probe | Orthopedic | Class 1 | 888.4540 | 2023-04-10 |
| HWN | Instrument, Compression | Orthopedic | Class 1 | 888.4540 | 2023-04-09 |
| IQK | Orthosis, Cervical | Physical Medicine | Class 1 | 890.3490 | 2024-05-24 |
| HSP | Splint, Traction | Orthopedic | Class 1 | 888.5890 | 2023-04-10 |
| BZB | Catheter, Nasal, Oxygen | Anesthesiology | Class 1 | 868.5350 | 2024-12-09 |
| HST | Apparatus, Traction, Non-Powered | Orthopedic | Class 1 | 888.5850 | 2023-04-10 |
| HDJ | Scissors, Umbilical | Obstetrics/Gynecology | Class 1 | 884.4520 | 2024-09-27 |
| HXK | Holder, Needle; Orthopedic | Orthopedic | Class 1 | 888.4540 | 2023-04-10 |
| GEN | Forceps, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2025-02-26 |
| LGG | Instrument, Cast Application/Removal, Manual | Orthopedic | Class 1 | 888.5980 | 2023-04-10 |
| HTO | Reamer | Orthopedic | Class 1 | 888.4540 | 2023-04-09 |
| FRI | Scale, Stand-On, Patient | General Hospital | Class 1 | 880.2700 | 2024-08-13 |
| HTF | Curette | General, Plastic Surgery | Class 1 | 878.4800 | 2024-07-05 |
| HXW | Bender | Orthopedic | Class 1 | 888.4540 | 2023-04-09 |
| FNK | Bed, Hydraulic, Adjustable Hospital | General Hospital | Class 1 | 880.5110 | 2025-04-05 |
| LRP | Tray, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2024-05-24 |
| PUE | Biomicroscope, Slit-Lamp, Ac-Powered, Exempt | Ophthalmic | Class 2 | 886.1850 | 2024-05-21 |
| GFB | Head, Surgical, Hammer | General, Plastic Surgery | Class 1 | 878.4820 | 2024-06-08 |
| GEA | Cannula, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2024-07-05 |
| HTE | Elevator | General, Plastic Surgery | Class 1 | 878.4800 | 2025-02-12 |
| HWL | Set, Hollow Mill | Orthopedic | Class 1 | 888.4540 | 2023-04-09 |
| EGN | Scissors, Surgical Tissue, Dental | Dental | Class 1 | 872.4565 | 2024-07-05 |
| ECX | Cylinder, Compressed Gas, And Valve | Anesthesiology | Class 1 | 868.2700 | 2025-03-08 |
| INY | Bed, Patient Rotation, Manual | Physical Medicine | Class 1 | 890.5180 | 2025-12-10 |
| HJH | Loupe, Binocular, Low Power | Ophthalmic | Class 1 | 886.5120 | 2025-03-07 |
| FNY | Basin, Emesis | General Hospital | Class 1 | 880.6730 | 2025-04-05 |
| GDN | Knife, Amputation | General, Plastic Surgery | Class 1 | 878.4800 | 2023-08-16 |
| IXO | Synchronizer, Ecg / Respirator, Radiographic | Radiology | Class 1 | 892.1970 | 2025-03-07 |
| LRW | Scissors, General, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2025-02-26 |
| HRW | Dynamometer, Nonpowered | Orthopedic | Class 1 | 888.1250 | 2023-04-09 |
| HXZ | Cutter, Wire | Orthopedic | Class 1 | 888.4540 | 2023-04-09 |
| HTX | Rongeur | Orthopedic | Class 1 | 888.4540 | 2023-04-09 |
| NXR | Fixation, Vision Training, Binocular | Ophthalmic | Class 1 | 886.1290 | 2025-03-07 |
| FRW | Scale, Patient | General Hospital | Class 1 | 880.2720 | 2024-05-21 |
| PCM | Portable Liquid Oxygen Unit Stand | Physical Medicine | Class 1 | 890.5050 | 2025-12-10 |
| IQG | Adaptor, Holder, Syringe | Physical Medicine | Class 1 | 890.5050 | 2024-09-27 |
| HSQ | Belt, Pelvic, Traction | Orthopedic | Class 1 | 888.5890 | 2023-08-16 |
| FPY | Sheet, Burn | General Hospital | Class 1 | 880.5180 | 2024-06-08 |
| GDZ | Handle, Scalpel | General, Plastic Surgery | Class 1 | 878.4800 | 2024-07-05 |
| EMF | Knife, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2024-05-24 |
| IWQ | Curtain, Protective, Radiographic | Radiology | Class 1 | 892.6500 | 2024-09-27 |
| HWD | Starter, Bone Screw | Orthopedic | Class 1 | 888.4540 | 2023-04-10 |
| HWO | Skid, Bone | Orthopedic | Class 1 | 888.4540 | 2023-04-09 |
| IKZ | Bed, Patient Rotation, Powered | Physical Medicine | Class 2 | 890.5225 | 2024-08-14 |
| QTO | Digital Visual Acuity Test | Ophthalmic | Class 1 | 886.1150 | 2025-03-07 |
| HPA | Frame, Trial, Ophthalmic | Ophthalmic | Class 1 | 886.1415 | 2024-05-21 |
| KTZ | Caliper | Orthopedic | Class 1 | 888.4150 | 2023-04-10 |
| FQA | Scale, Surgical Sponge | General Hospital | Class 1 | 880.2740 | 2024-08-13 |
| IXQ | Table, Radiographic, Stationary Top | Radiology | Class 2 | 892.1980 | 2025-03-08 |
| LYQ | Accessories, Fixation, Spinal Intervertebral Body | Orthopedic | Class 1 | 888.4540 | 2023-04-10 |
| HLJ | Ophthalmoscope, Battery-Powered | Ophthalmic | Class 2 | 886.1570 | 2024-09-27 |
| HRK | Table, Instrument, Manual, Ophthalmic | Ophthalmic | Class 1 | 886.4855 | 2025-03-08 |
| FCE | Enema Kit | Gastroenterology, Urology | Class 1 | 876.5210 | 2024-05-21 |
| HPC | Set, Lens, Trial, Ophthalmic | Ophthalmic | Class 1 | 886.1405 | 2024-05-21 |
| HWP | Punch, Femoral Neck | Orthopedic | Class 1 | 888.4540 | 2023-04-10 |
| EIG | Retractor, All Types | Dental | Class 1 | 872.4565 | 2024-07-05 |
| HMW | Drape, Microscope, Ophthalmic | General, Plastic Surgery | Class 2 | 878.4370 | 2024-08-13 |
| HWX | Tap, Bone | Orthopedic | Class 1 | 888.4540 | 2023-04-09 |
| KDC | Instrument, Surgical, Disposable | General, Plastic Surgery | Class 1 | 878.4800 | 2025-03-08 |
| HRR | Scissors, Orthopedic, Surgical | Orthopedic | Class 1 | 888.4540 | 2023-04-10 |
| HKO | Refractometer, Ophthalmic | Ophthalmic | Class 1 | 886.1760 | 2024-05-21 |
| LRC | Instrument, Ent Manual Surgical | Ear, Nose, Throat | Class 1 | 874.4420 | 2024-05-24 |
| LRY | Punch, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2024-07-05 |
| HXC | Wrench | Orthopedic | Class 1 | 888.4540 | 2023-04-10 |
| INF | Scale, Platform, Wheelchair | Physical Medicine | Class 1 | 890.3940 | 2024-08-13 |
| GAF | Spatula, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2025-03-08 |
| HOI | Spectacle, Magnifying | Ophthalmic | Class 1 | 886.5840 | 2025-03-07 |
| NWF | Drill, Battery Powered, Subungual Hematoma | General, Plastic Surgery | Class 1 | 878.4820 | 2023-08-16 |
| HXJ | Staple Driver | Orthopedic | Class 1 | 888.4540 | 2023-04-10 |
| KZO | Ink, Arch Tracing | Dental | Class 1 | 872.3150 | 2024-09-27 |
| JTM | Anaerobic Box Glove | Microbiology | Class 1 | 866.2120 | 2024-09-27 |
| FSM | Tray, Surgical, Instrument | General, Plastic Surgery | Class 1 | 878.4800 | 2024-05-21 |
| FHI | Ring, Laparotomy | Gastroenterology, Urology | Class 1 | 876.4730 | 2024-05-24 |
| HXX | Screwdriver | Orthopedic | Class 1 | 888.4540 | 2023-04-10 |
| HXE | Fork | Orthopedic | Class 1 | 888.4540 | 2023-04-10 |
| LXH | Orthopedic Manual Surgical Instrument | Orthopedic | Class 1 | 888.4540 | 2023-04-10 |
| FHQ | Holder, Needle, Gastroenterologic | Gastroenterology, Urology | Class 1 | 876.4730 | 2025-02-26 |
| LYS | Bone Mill | Orthopedic | Class 1 | 888.4540 | 2023-04-10 |
| ETK | Tube, Toynbee Diagnostic | Ear, Nose, Throat | Class 1 | 874.1925 | 2024-05-24 |
| LDE | Stethoscope, Manual | Cardiovascular | Class 1 | 870.1875 | 2024-05-21 |
| FOX | Stand, Infusion | General Hospital | Class 1 | 880.6990 | 2024-05-21 |
| HWK | Trephine | Orthopedic | Class 1 | 888.4540 | 2023-04-10 |
| KOH | Instrument, Manual, General Obstetric-Gynecologic | Obstetrics/Gynecology | Class 1 | 884.4520 | 2024-05-24 |
| HTD | Forceps | General, Plastic Surgery | Class 1 | 878.4800 | 2024-05-24 |
| HOX | Chart, Visual Acuity | Ophthalmic | Class 1 | 886.1150 | 2025-03-07 |
| GDC | Table, Operating-Room, Electrical | General, Plastic Surgery | Class 1 | 878.4960 | 2025-03-07 |
| FPP | Stretcher, Hand-Carried | General Hospital | Class 1 | 880.6900 | 2024-05-21 |
| FNJ | Bed, Manual | General Hospital | Class 1 | 880.5120 | 2024-08-14 |
| JQC | Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | Clinical Chemistry | Class 1 | 862.2050 | 2024-08-13 |
| EBL | Pin, Retentive And Splinting, And Accessory Instruments | Dental | Class 1 | 872.3740 | 2025-02-12 |
| ITG | Bandage, Cast | Physical Medicine | Class 1 | 890.3025 | 2024-09-27 |
| HCY | Curette, Uterine | Obstetrics/Gynecology | Class 1 | 884.4530 | 2024-05-24 |
| HTP | File | Orthopedic | Class 1 | 888.4540 | 2023-04-10 |
| KBL | Depressor, Metal Tongue, Surgical | Ear, Nose, Throat | Class 1 | 874.4420 | 2024-09-27 |
| FMP | Protector, Skin Pressure | General Hospital | Class 1 | 880.6450 | 2025-02-12 |
| HXY | Brace, Drill | Orthopedic | Class 1 | 888.4540 | 2023-04-10 |
| EME | Punch, Biopsy, Surgical | Dental | Class 1 | 872.4565 | 2024-07-05 |
| JCY | Catheter, Infusion | General, Plastic Surgery | Class 1 | 878.4200 | 2025-03-08 |
| HWJ | Awl | Orthopedic | Class 1 | 888.4540 | 2023-04-09 |
| EBR | Unit, Suction Operatory | Dental | Class 1 | 872.6640 | 2024-07-05 |
| HSS | Halter, Head, Traction | Orthopedic | Class 1 | 888.5890 | 2023-04-09 |
| KSE | Refrigerator, Freezer, Blood Storage | Hematology | Class 2 | 864.9700 | 2024-09-27 |
| ISR | Band Or Belt, Pelvic Support | Physical Medicine | Class 1 | 890.3025 | 2024-05-24 |
| JEX | Plier, Orthodontic | Dental | Class 1 | 872.4565 | 2025-02-26 |
| HTQ | Broach | Orthopedic | Class 1 | 888.4540 | 2023-04-09 |
| EMG | Forceps, Tooth Extractor, Surgical | Dental | Class 1 | 872.4565 | 2025-02-26 |
| HXN | Applier, Cerclage | Orthopedic | Class 1 | 888.4540 | 2023-04-10 |
| BZN | Cart, Emergency, Cardiopulmonary (Excluding Equipment) | Anesthesiology | Class 1 | 868.6175 | 2024-08-14 |
| GDT | Staple, Removable (Skin) | General, Plastic Surgery | Class 1 | 878.4760 | 2024-05-24 |
| HXD | Clamp | General, Plastic Surgery | Class 1 | 878.4800 | 2025-02-26 |
| MRL | Scale, Sponge, Surgical, Electrically-Powered | General Hospital | Class 1 | 880.2740 | 2024-08-13 |
| KIK | Hook, Bone | General, Plastic Surgery | Class 1 | 878.4800 | 2024-07-05 |
| LCH | Tonometer (Calibration And Q.C. Of Blood-Gas Instruments), Clinical | Clinical Chemistry | Class 1 | 862.1660 | 2025-03-07 |
| FZY | Hammer, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2024-06-08 |
| LXI | Guide, Drill, Ligament | General, Plastic Surgery | Class 1 | 878.4820 | 2025-02-12 |
| HTS | Knife, Orthopedic | Orthopedic | Class 1 | 888.4540 | 2023-04-10 |
| IKO | Hammer, Reflex, Powered | Physical Medicine | Class 2 | 890.1450 | 2024-09-27 |
| NBH | Accessories, Arthroscopic | Orthopedic | Class 1 | 888.1100 | 2023-04-10 |
| JSR | Kit, Identification, Dermatophyte | Microbiology | Class 1 | 866.2660 | 2025-03-07 |
| HRT | Stripper, Surgical | Orthopedic | Class 1 | 888.4540 | 2023-04-10 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2024-12-10 |
| EMH | Forceps, Rongeur, Surgical | Dental | Class 1 | 872.4565 | 2024-07-05 |
| HWW | Countersink | Orthopedic | Class 1 | 888.4540 | 2023-04-10 |
| GIO | Tube, Collection, Capillary Blood | Hematology | Class 1 | 864.6150 | 2024-09-27 |
| HKM | Retinoscope, Battery-Powered | Ophthalmic | Class 1 | 886.1780 | 2025-03-07 |
| KCY | Tourniquet, Pneumatic | General, Plastic Surgery | Class 1 | 878.5910 | 2023-08-16 |
| JAC | System, X-Ray, Film Marking, Radiographic | Radiology | Class 1 | 892.1640 | 2025-03-07 |
| HXL | Mallet | General, Plastic Surgery | Class 1 | 878.4800 | 2025-02-12 |
| DZM | Needle, Dental | Dental | Class 1 | 872.4730 | 2024-09-27 |
| PTX | Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile, Exempt | General, Plastic Surgery | Class 2 | 878.4495 | 2024-05-24 |
| ILH | Splint, Hand, And Components | Physical Medicine | Class 1 | 890.3475 | 2024-05-24 |
| EPN | Pump, Nebulizer, Manual | Ear, Nose, Throat | Class 1 | 874.5220 | 2024-09-27 |
| OAR | Injector, Vertebroplasty (Does Not Contain Cement) | Orthopedic | Class 1 | 888.4200 | 2023-04-10 |
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K951176 | Siemens Medical Solutions USA, Inc. | KOORDINAT M | 1995-04-20 |
| K851170 | The Huxley Instrument Corp. | DISSECTING TWEEZER #283-72PCS. SS 410 | 1985-04-25 |
| K821248 | Conphar, Inc. | ROCHESTER PEAN FORCEPS | 1982-05-28 |
| K881095 | CooperVision, Inc. | KOI(TM) INSTRUMENT TRAYS | 1988-04-06 |
| K863293 | Lifestream Int'L, Inc. | DISPOSABLE SUCTION CANNULA NO. 902008-000 | 1986-09-09 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0006-2025 | Ossur H F Grjothals 5 Reykjavik Iceland | 1 | Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101 |
| Z-0021-2015 | Biomet, Inc. | 1 | Compress Face Reamer
Product Usage:
Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement, tumor resections, revision of previously failed total joint arthroplasty, and trauma. |
| Z-0036-2010 | Alphatec Spine, Inc. | 1 | ROC Lumbar bolt caddy, Part Number: 81997-01-05.
Sterilization container for ROC bolts/screws. Product is used to contain spinal implants. |
| Z-0039-2018 | Teleflex Medical | 1 | Pilling Knife Handles:
a) REF 352950
b) REF 352953
c) REF 352951
d) REF 352957
e) REF 352952 :
Reusable surgical knife handles, which are intended for use with blades which are inserted into a slot in the handle. |
| Z-0027-2016 | Zimmer, Inc. | 1 | Zimmer Universal Locking System, Titanium 3.5mm.
Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices. |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3004176895 | BK MEDITECH CO., LTD. | Hwaseong-si Gyeonggi, KR |
| 3014334038 | Integra LifeSciences Production Corporation | Mansfield, MA, US |
| 3033509898 | STRAITS ORTHOPAEDICS (MFG) SDN BHD | Bandar Cassia Pulau Pinang, MY |
| 2431166 | Sklar Corporation | West Chester, PA, US |
| 3000931034 | Tornier S.A.S. | Montbonnot Saint-Martin Isere, FR |
3013846070 when referencing this establishment in official correspondence.