Alto Development Corp.
United Statesfrom the FDA registration address FDA establishment FEI 2242056
- Devices
- 10
- Registrations
- FDA
- FDA recalls
- 7
What Alto Development Corp. makes
ALTO DEVELOPMENT CORP. manufactures medical devices including electro-cautery suction tubes, electrosurgical connecting cords, electrosurgical pencils, pressure monitoring IV bottle caps, and sutures such as MYO/WIRE II sternotomy sutures and Raney clips.
The company's products are listed in the FDA 510(k) registry and include Class I and Class II devices. ALTO DEVELOPMENT CORP. is based in the US.
Catalogue
Myo/Clip Ref K821518
Regimes: 510(k) Registry: 510(k)Electro-Cautery Suction Tube Ref K881413
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
A&E Medical Electrosurg Electro W/Non-Stick Coat Ref K931537
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Labeling For Myo/Wire Ii Sternotomy Sutures Ref K932513
Regimes: 510(k) Registry: 510(k)Raney Clip Ref K884783
Regimes: 510(k) Registry: 510(k)A&E Medical Electrosurgical Connecting Cords Ref K930528
Regimes: 510(k) Registry: 510(k)Pressure Monitoring Iv Bottle Cap Ref K831867
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 2242056
- Address
- 5206 Asbury Road, FARMINGDALE, NJ, 07727
FDA recalls
FDA recall records list 7 recalls initiated by ALTO DEVELOPMENT CORP., the earliest on 2017-10-23 and the most recent on 2019-09-10. By recorded status: 7 terminated. The reasons filed fall into these groups: labeling or instructions for use, sterility or contamination and packaging. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 1
- 2018 0
- 2019 6
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2019
- 10 Sep 2019 Z-0242-2020 Class II Terminated Some Thorecon disposable tensioners supplied in different Plating System Kits exhibit a molding defect which occludes the through-channel for cable tensioning, rendering the tensioner inoperable.
- 10 Sep 2019 Z-0243-2020 Class II Terminated Some Thorecon disposable tensioners supplied in different Plating System Kits exhibit a molding defect which occludes the through-channel for cable tensioning, rendering the tensioner inoperable.
- 10 Sep 2019 Z-0244-2020 Class II Terminated Some Thorecon disposable tensioners supplied in different Plating System Kits exhibit a molding defect which occludes the through-channel for cable tensioning, rendering the tensioner inoperable.
- 10 Sep 2019 Z-0245-2020 Class II Terminated Some Thorecon disposable tensioners supplied in different Plating System Kits exhibit a molding defect which occludes the through-channel for cable tensioning, rendering the tensioner inoperable.
- 10 Sep 2019 Z-0246-2020 Class II Terminated Some Thorecon disposable tensioners supplied in different Plating System Kits exhibit a molding defect which occludes the through-channel for cable tensioning, rendering the tensioner inoperable.
- 21 Jun 2019 Z-2098-2019 Class II Terminated Updated instructions for use: Ultra-Flex MYO/WIRE Monopolar pacing wire looped electrode (M-21 Series) to be consistent between electrode IFU and instructions for M-21 loop.
2017
- 23 Oct 2017 Z-0813-2018 Class II Terminated Surgical punches are being recalled due to potential packaging damage which may have occurred during transportation resulting in loss of sterility.
Frequently asked questions
How many devices does ALTO DEVELOPMENT CORP. have in the registry?
The registry currently lists 10 devices for ALTO DEVELOPMENT CORP.. Devices recorded under merged duplicate company entries are counted once.
Which registries list ALTO DEVELOPMENT CORP.'s devices?
Among its 10 most recently registered devices, ALTO DEVELOPMENT CORP. has devices listed in FDA 510(k) (10 devices).
What risk classes do ALTO DEVELOPMENT CORP.'s devices fall under?
Among its 10 most recently registered devices, the classes recorded for ALTO DEVELOPMENT CORP.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for ALTO DEVELOPMENT CORP.?
FDA recall records list 7 recalls initiated by ALTO DEVELOPMENT CORP., the most recent initiated on 10 Sep 2019. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from ALTO DEVELOPMENT CORP. in the registry?
The most recently registered devices listed for ALTO DEVELOPMENT CORP. include MYO/CLIP, ELECTRO-CAUTERY SUCTION TUBE, A&E MEDICAL CORP DISPOS SUCT COAG W/NON STICK COAT and A&E MEDICAL ELECTROSURG ELECTRO W/NON-STICK COAT.