FDA Device Registration & Listing · Scottsdale, AZ, US · Registration 1424478
Normalized identity and public registration information from FDA records.
No proprietary names listed under this establishment.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| HOE | Caliper, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2023-11-10 |
| HWM | Osteotome | General, Plastic Surgery | Class 1 | 878.4800 | 2020-08-03 |
| FZX | Guide, Surgical, Instrument | General, Plastic Surgery | Class 1 | 878.4800 | 2020-08-03 |
| GZT | Retractor, Self-Retaining, For Neurosurgery | Neurology | Class 2 | 882.4800 | 2020-08-03 |
| HNR | Forceps, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2020-08-03 |
| KAL | Retractor, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2020-08-03 |
| EPY | Speculum, Ent | General, Plastic Surgery | Class 1 | 878.1800 | 2020-08-03 |
| JYT | Pick, Microsurgical Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-11-10 |
| HDK | Scissors, Episiotomy | Obstetrics/Gynecology | Class 1 | 884.4520 | 2020-08-03 |
| DWP | Dilator, Vessel, Surgical | Cardiovascular | Class 2 | 870.4475 | 2020-08-03 |
| HCY | Curette, Uterine | Obstetrics/Gynecology | Class 1 | 884.4530 | 2020-08-03 |
| FFN | Clamp, Non-Electrical | Gastroenterology, Urology | Class 1 | 876.4730 | 2021-07-20 |
| FTY | Tape, Measuring, Rulers And Calipers | General, Plastic Surgery | Class 1 | 878.4800 | 2020-08-03 |
| LRY | Punch, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2020-08-03 |
| FZY | Hammer, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2020-08-03 |
| HAO | Instrument, Surgical, Non-Powered | Neurology | Class 1 | 882.4535 | 2020-08-03 |
| HCF | Instrument, Ligature Passing And Knot Tying | General, Plastic Surgery | Class 1 | 878.4800 | 2020-08-03 |
| FHL | Scoop | Gastroenterology, Urology | Class 1 | 876.4730 | 2020-08-03 |
| HFB | Forceps, Biopsy, Gynecological | Obstetrics/Gynecology | Class 1 | 884.4530 | 2020-08-03 |
| KIK | Hook, Bone | General, Plastic Surgery | Class 1 | 878.4800 | 2020-08-03 |
| FBM | Cannula And Trocar, Suprapubic, Non-Disposable | Gastroenterology, Urology | Class 1 | 876.5090 | 2020-08-03 |
| HTC | Pliers, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2020-08-03 |
| HWJ | Awl | Orthopedic | Class 1 | 888.4540 | 2021-04-22 |
| KAR | Irrigator, Sinus | Ear, Nose, Throat | Class 1 | 874.4420 | 2020-08-03 |
| GWX | Fork, Tuning | Neurology | Class 1 | 882.1525 | 2020-08-03 |
| EMM | Chisel, Osteotome, Surgical | Dental | Class 1 | 872.4565 | 2020-08-03 |
| KCJ | Applicator, Ent | Ear, Nose, Throat | Class 1 | 874.5220 | 2020-08-03 |
| HCZ | Forceps, Surgical, Gynecological | Obstetrics/Gynecology | Class 2 | 884.4530 | 2020-08-03 |
| GAF | Spatula, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2023-11-10 |
| GDI | Dissector, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2020-08-03 |
| HDL | Retractor, Vaginal | Obstetrics/Gynecology | Class 1 | 884.4520 | 2020-08-03 |
| LRW | Scissors, General, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2020-08-03 |
| EMK | Curette, Surgical, Dental | Dental | Class 1 | 872.4565 | 2020-08-03 |
| GEN | Forceps, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2020-08-03 |
| KBN | Gag, Mouth | Ear, Nose, Throat | Class 1 | 874.4420 | 2020-08-03 |
| FHN | Ligator, Hemorrhoidal | Gastroenterology, Urology | Class 2 | 876.4400 | 2020-08-03 |
| GDZ | Handle, Scalpel | General, Plastic Surgery | Class 1 | 878.4800 | 2020-08-03 |
| HXZ | Cutter, Wire | Orthopedic | Class 1 | 888.4540 | 2020-08-03 |
| MDM | Instrument, Manual, Surgical, General Use | General, Plastic Surgery | Class 1 | 878.4800 | 2020-08-03 |
| HNF | Scissors, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2020-08-03 |
| KBJ | Curette, Adenoid | Ear, Nose, Throat | Class 1 | 874.4420 | 2020-08-03 |
| KDG | Chisel (Osteotome) | General, Plastic Surgery | Class 1 | 878.4820 | 2020-08-03 |
| HXY | Brace, Drill | Orthopedic | Class 1 | 888.4540 | 2020-08-03 |
| DWS | Instruments, Surgical, Cardiovascular | Cardiovascular | Class 1 | 870.4500 | 2020-08-03 |
| JYL | Hook, Microsurgical Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2020-08-03 |
| GEA | Cannula, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2020-08-03 |
| GDG | Hook, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2020-08-03 |
| KAE | Forceps, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2020-08-03 |
| GZX | Instrument, Microsurgical | Neurology | Class 1 | 882.4525 | 2020-08-03 |
| HDQ | Dilator, Cervical, Fixed Size | Obstetrics/Gynecology | Class 1 | 884.4530 | 2020-08-03 |
| GEG | Elevator, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2020-08-03 |
| HXG | Tamp | Orthopedic | Class 1 | 888.4540 | 2020-08-03 |
| EMJ | Elevator, Surgical, Dental | Dental | Class 1 | 872.4565 | 2021-05-03 |
| DXC | Clamp, Vascular | Cardiovascular | Class 2 | 870.4450 | 2020-08-03 |
| FZS | Curette, Surgical, General Use | General, Plastic Surgery | Class 1 | 878.4800 | 2020-08-03 |
| KAD | Elevator, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2020-08-03 |
| FFO | Retractor, Self-Retaining | Gastroenterology, Urology | Class 1 | 876.4730 | 2023-11-10 |
| HRQ | Hemostat | General, Plastic Surgery | Class 1 | 878.4800 | 2020-08-03 |
| KAN | Chisel, Nasal | General, Plastic Surgery | Class 1 | 878.4800 | 2020-08-03 |
| HAE | Rongeur, Manual | Neurology | Class 2 | 882.4840 | 2020-08-03 |
| JYH | Excavator, Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2020-08-03 |
| HRT | Stripper, Surgical | Orthopedic | Class 1 | 888.4540 | 2023-11-10 |
| HTJ | Gauge, Depth | Orthopedic | Class 1 | 888.4300 | 2020-08-03 |
| KTE | Trocar, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2020-08-03 |
| GAD | Retractor | General, Plastic Surgery | Class 1 | 878.4800 | 2020-08-03 |
No US Agent registered (Local establishment).
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K834189 | Imm Enterprises , Ltd. | JAKOBI SURG. INSTRUMENTS #7 44/47 | 1984-03-06 |
| K810894 | American Edwards Laboratories | FOGARTY FLEXIBLE CALIBRATOR | 1981-05-15 |
| K851170 | The Huxley Instrument Corp. | DISSECTING TWEEZER #283-72PCS. SS 410 | 1985-04-25 |
| K821248 | Conphar, Inc. | ROCHESTER PEAN FORCEPS | 1982-05-28 |
| K000397 | Boston Scientific Corp | SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228; INJECTION SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODEL | 2000-03-07 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| 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-0008-04 | Rultract Inc | 1 | Rultract Surgical Retractor, 4100 Series, all system configurations, reusable. |
| Z-0034-2012 | X Spine Systems Inc | 1 | Axle Interspinous Fusion System Torque Driver Handle, Model #: X060-0323, Lot # 525941, S/Ns 001-017, Lot # 525942, S/Ns 001-050, Mfr. By: Bradshaw Medical Inc., Kenosha, WI 53144
The Axle Torque Driver Handle is used to lock the set screw into the locking plate. |
| Z-0031-2014 | Aesculap, Inc. | 1 | UNITRAC Pneumatic Retraction Arm.
A support arm used to hold surgical instruments during surgical procedures. |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3007507973 | ADLER INSTRUMENT COMPANY | Brooksville, FL, US |
| 1057946 | KLS-Martin L.P. | Jacksonville, FL, US |
| 3013602181 | Blink Medical LTD | Solihull, GB |
| 3006554912 | STERIS Deutschland GmBh | Wurmlingen Baden-Wurttemberg, DE |
| 8043606 | Bumueller GmbH | IRNDORF Baden-Wurttemberg, DE |
1424478 when referencing this establishment in official correspondence.