FDA Device Registration & Listing · Solihull, GB · Registration 3013602181
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| GDY | Gauze/Sponge, Internal, X-Ray Detectable | General, Plastic Surgery | Class 1 | 878.4450 | 2021-12-15 |
| GDI | Dissector, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2007-11-19 |
| HOE | Caliper, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 1993-01-01 |
| LRW | Scissors, General, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2008-08-21 |
| HNQ | Hook, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 1993-01-01 |
| HNC | Specula, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 1993-01-01 |
| FHQ | Holder, Needle, Gastroenterologic | Gastroenterology, Urology | Class 1 | 876.4730 | 1993-01-01 |
| HOD | Clamp, Eyelid, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2001-08-29 |
| HNI | Retractor, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 1993-01-01 |
| HNZ | Curette, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 1993-01-01 |
| MDM | Instrument, Manual, Surgical, General Use | General, Plastic Surgery | Class 1 | 878.4800 | 2007-10-31 |
| LRP | Tray, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2022-04-12 |
| PZG | Surgical Eye Tray | Ophthalmic | Class 1 | 886.4350 | 2019-08-28 |
| HMQ | Marker, Sclera | Ophthalmic | Class 1 | 886.4570 | 1993-01-01 |
| GEN | Forceps, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2008-08-21 |
| HMR | Marker, Ocular | Ophthalmic | Class 1 | 886.4570 | 1993-01-01 |
| HNW | Dilator, Lachrymal | Ophthalmic | Class 1 | 886.4350 | 1993-01-01 |
| HNF | Scissors, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 1993-01-01 |
| PXV | General Purpose Instrument Tray | General, Plastic Surgery | Class 1 | 878.4800 | 2022-04-11 |
| HND | Spatula, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 1993-01-01 |
| HNL | Probe, Lachrymal | Ophthalmic | Class 1 | 886.4350 | 1993-01-01 |
| HNR | Forceps, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 1993-01-01 |
| NAB | Gauze / Sponge,Nonresorbable For External Use | General, Plastic Surgery | Class 1 | 878.4014 | 2022-04-11 |
| GAD | Retractor | General, Plastic Surgery | Class 1 | 878.4800 | 2022-07-15 |
| FMH | Container, Specimen, Sterile | Pathology | Class 1 | 864.3250 | 2021-12-15 |
| PYB | Minor Surgical Procedures Tray | General, Plastic Surgery | Class 1 | 878.4800 | 2022-04-11 |
| HMX | Cannula, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 1993-01-01 |
| OJV | Single Use Instrument Tray | General, Plastic Surgery | Class 1 | 878.4800 | 2021-12-26 |
| HNB | Spoon, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 1993-01-01 |
| GDJ | Clamp, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 1993-01-01 |
| KDC | Instrument, Surgical, Disposable | General, Plastic Surgery | Class 1 | 878.4800 | 1977-12-08 |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 1835993 | BARRON PRECISION INSTRUMENTS, L.L.C. | Grand Blanc, MI, US |
| 2242450 | KATENA PRODUCTS, INC. | Randolph, NJ, US |
| 1934420 | KATENA PRODUCTS, INC. | Fenton, MO, US |
| 3015177648 | KATENA PRODUCTS, INC. | Parsippany, NJ, US |
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K790050 | Stanford Professional Products | SPONGES, STANFORD STERILE LAP | 1979-01-17 |
| K881095 | CooperVision, Inc. | KOI(TM) INSTRUMENT TRAYS | 1988-04-06 |
| K851170 | The Huxley Instrument Corp. | DISSECTING TWEEZER #283-72PCS. SS 410 | 1985-04-25 |
| K821248 | Conphar, Inc. | ROCHESTER PEAN FORCEPS | 1982-05-28 |
| K922626 | Andronic Devices, Ltd. | ADEPT INSTRUMENT POSITIONING ACCESSORY | 1992-10-19 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| 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-0031-2014 | Aesculap, Inc. | 1 | UNITRAC Pneumatic Retraction Arm.
A support arm used to hold surgical instruments during surgical procedures. |
| Z-0011-2019 | Ellex iScience, Inc. | 1 | ellex I.Science iTRACK 250A, Canaloplasty Microcatheter Kit, for single use, REF iT-250A, Rx. The firm name on the label is Ellex iScience, Inc., Fremont, CA. Used in ophthalmic surgery. |
| Z-0022-2009 | Becton Dickinson and Company | 1 | BD Visitec High Viscosity Injector, 4mm
Ref: 585173. The product is intended for Vitroretinal Surgery. |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 1526711 | ISOMEDIX OPERATIONS INC | GROVEPORT, OH, US |
| 3016758972 | ANJI SPENQ INDUSTRIAL CO., LTD. | Huzhou Zhejiang, CN |
| 1058584 | Sterigenics US LLC | Charlotte, NC, US |
| 2027062 | BIOSEAL | PLACENTIA, CA, US |
| 3010610950 | Winner Medical (Chongyang) Co., Ltd. | Chongyang Hubei, CN |
3013602181 when referencing this establishment in official correspondence.