FDA Device Registration & Listing · NEENAH, WI, US · Registration 2182318
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 |
|---|---|---|---|---|---|
| KIA | Cover, Cast | General Hospital | Class 1 | 880.6185 | 2021-09-02 |
| BSK | Cuff, Tracheal Tube, Inflatable | Anesthesiology | Class 2 | 868.5750 | 2024-08-12 |
| FRG | Wrap, Sterilization | General Hospital | Class 2 | 880.6850 | 2007-12-18 |
| FMQ | Restraint, Protective | General Hospital | Class 1 | 880.6760 | 2019-12-30 |
| CCW | Laryngoscope, Rigid | Anesthesiology | Class 1 | 868.5540 | 2019-04-30 |
| EIA | Unit, Operative Dental | Dental | Class 1 | 872.6640 | 2022-09-02 |
| FLL | Continuous Measurement Thermometer | General Hospital | Class 2 | 880.2910 | 2007-12-18 |
| FOK | Pad, Neonatal Eye | General Hospital | Class 1 | 880.5270 | 2019-12-30 |
| EGZ | Holder, Film, X-Ray | Dental | Class 1 | 872.1905 | 2008-06-12 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Radiology | Class 2 | 892.1560 | 2022-02-09 |
| EAJ | Apron, Leaded | Radiology | Class 1 | 892.6500 | 2019-01-22 |
| PJP | Fall Prevention Alarm/Sensor Attached Only | General Hospital | Class 1 | 880.2400 | 2019-12-30 |
| KME | Bedding, Disposable, Medical | General Hospital | Class 1 | 880.6060 | 1992-07-16 |
| EIA | Unit, Operative Dental | Dental | Class 1 | 872.6640 | 2024-09-24 |
| NNW | Bag, Urine Collection, Leg, For External Use, Non-Sterile | Gastroenterology, Urology | Class 1 | 876.5250 | 2019-12-30 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Radiology | Class 2 | 892.1560 | 2019-01-22 |
| KGX | Tape And Bandage, Adhesive | General Hospital | Class 1 | 880.5240 | 2019-01-09 |
| IKX | Aid, Transfer | Physical Medicine | Class 1 | 890.5050 | 2019-12-30 |
| QAI | Powered Microneedle Device | General, Plastic Surgery | Class 2 | 878.4430 | 2025-03-04 |
| PUI | Drape, Surgical, Exempt | General, Plastic Surgery | Class 2 | 878.4370 | 2019-01-22 |
| FNL | Bed, Ac-Powered Adjustable Hospital | General Hospital | Class 2 | 880.5100 | 2019-12-30 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2021-05-03 |
| EFN | Cotton, Roll | Dental | Class 1 | 872.6050 | 2001-04-04 |
| FMP | Protector, Skin Pressure | General Hospital | Class 1 | 880.6450 | 2019-12-30 |
| NAB | Gauze / Sponge,Nonresorbable For External Use | General, Plastic Surgery | Class 1 | 878.4014 | 2001-04-04 |
| KMI | Monitor, Bed Patient | General Hospital | Class 1 | 880.2400 | 2019-12-20 |
| OEA | Non-Surgical Gown | General, Plastic Surgery | Class 1 | 878.4040 | 2008-10-17 |
| PJO | Fall Prevention Alarm/Sensor Combination Attached Or Unattached | General Hospital | Class 1 | 880.2400 | 2019-12-30 |
| ECB | Unit, Syringe, Air And/Or Water | Dental | Class 1 | 872.4565 | 2019-12-19 |
| PLI | Gastrointestional Tube Holder | Gastroenterology, Urology | Class 2 | 876.5980 | 2019-01-09 |
| EYJ | Holder, Ureteral Catheter | Gastroenterology, Urology | Class 1 | 876.5130 | 2017-02-08 |
| PEM | Dental Barriers And Sleeves | General, Plastic Surgery | Class 2 | 878.4370 | 2014-02-20 |
| CAT | Cannula, Nasal, Oxygen | Anesthesiology | Class 1 | 868.5340 | 2024-03-20 |
| KHR | Absorber, Saliva, Paper | Dental | Class 1 | 872.6050 | 2002-12-10 |
| EYQ | Garment, Protective, For Incontinence | Gastroenterology, Urology | Class 1 | 876.5920 | 2003-05-05 |
| NOC | Splint, Extremity, Non-Inflatable, External, Non-Sterile | General, Plastic Surgery | Class 1 | 878.3910 | 2019-12-30 |
| GDX | Scalpel, One-Piece | General, Plastic Surgery | Class 1 | 878.4800 | 2022-04-07 |
No US Agent registered (Local establishment).
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3002563411 | POSEY, S. de R.L. de C.V. | TIJUANA Baja California, MX |
| 3042176500 | Posey, S. De R.L. De C.V. | Tijuana Baja California, MX |
| 3029906632 | Posey S. de R.L. de C.V. | Tijuana, Baja California Mexico, MX |
| 3010699203 | Posey, S. de R.L. de C.V. | Tijuana Baja California, MX |
| 3031564213 | Posey, S. de R.L. de C.V. | Tijuana Baja California, MX |
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K962327 | Sekure Seat Corp. | SEKURE SEAT ADULT PASSIVE RESTRAINING DEVICE | 1997-03-06 |
| K963243 | Heelbo, Inc. | HEELBO BLAZER SLEEVED JACKET | 1996-10-01 |
| K010462 | Avita Corporation | AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES) | 2001-04-11 |
| K760421 | Arbrook Mfg. Corp. | THERMOMETER, SURVALENT-ELECTRONIC | 1976-08-23 |
| K813409 | Yellow Springs Instrument Co., Inc. | MODEL 2100 DUAL-DISPLAY TELE-THERMOMETER | 1981-12-18 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0006-2014 | H & H Associates | 2 | H&H Emergency Cricothyrotomy Kit (Part No. HHECT01/ HHECTK01, NSN 6515-01-573-0692), vacuum sealed and packaged in a 5 mil poly bags, labeled in part ***H & H Associates, Inc. CAGE 1NNH6 www.gohandh.com Ordinary, VA 23131 (800) 326-5708***.
The product is used to maintain fracture alignment. |
| Z-0144-2024 | Covidien | 1 | Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000 |
| Z-0168-2024 | Covidien | 1 | McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-017-000, Sterile EO, Rx Only |
| Z-0169-2024 | Covidien | 1 | McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-084-000, Sterile EO, Rx Only |
| Z-0003-2011 | Verathon, Inc. | 2 | BVI 9600 Bladder Volume Instrument, Aorta Scan Mode
The BladderScan BVI 9600 with AortaScan Mode is a user-selectable, dual-function ultrasound device that projects ultrasound energy either into the lower abdomen to obtain an image of the bladder for measuring bladder volume, or into the mid-abdomen to obtain an image of the abdominal aorta for aortic diameter measurements. |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3019312260 | MCADAM LLOYD INC | Chicago, IL, US |
| 3013876064 | PRECISION DIPPING MANUFACTURING LTD | Yate Bristol, City of, GB |
| 3014847663 | ASIA QUALITY & TECHNICAL SERVICES INC. (ASIA TECHNICAL SERVICES) | Taichung City, TW |
| 1926174 | Brownmed | Spirit Lake, IA, US |
| 3013180212 | NINGBO MPF MANUFACTURING CO.,LTD. | Ningbo Zhejiang, CN |
2182318 when referencing this establishment in official correspondence.