Alto Development Corp.
Medical device manufacturer in Wall Township, NJ.
10510(k) clearances
0PMA approvals
7recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K964621 | A & E Medical Electrocautery Suction Tube with Finger Tip Activator ButtonGEI · Traditional | 12/20/1996SE |
| K932513 | Labeling for Myo/Wire II Sternotomy SuturesGAO · Traditional | 01/07/1994SE |
| K931537 | A&E Medical Electrosurg Electro W/Non-Stick CoatGEI · Traditional | 09/07/1993SE |
| K930528 | A&E Medical Electrosurgical Connecting CordsGEI · Traditional | 05/17/1993SE |
| K914193 | A&E Medical Corp Dispos Suct Coag W/Non Stick CoatGEI · Traditional | 10/05/1992SE |
| K915300 | A & Em Medical Electrosurgical Pencil/AccessoriesGEI · Traditional | 02/18/1992SE |
| K884783 | Raney ClipFZQ · Traditional | 11/30/1988SE |
| K881413 | Electro-Cautery Suction TubeGEI · Traditional | 04/21/1988SE |
| K831867 | Pressure Monitoring IV Bottle CapDRS · Traditional | 08/12/1983SE |
| K821518 | Myo/ClipLDF · Traditional | 07/08/1982SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0246-2020 Class II | A&E Medical Thorecon Plating System Kits Model No. 94-1700-10. For fracture fixation or…Some Thorecon disposable tensioners supplied in different Plating System Kits exhibit a molding defect which… | 09/10/2019Terminated |
| Z-0245-2020 Class II | A&E Medical Thorecon Plating System Kits Model No. 94-1500-04-S. For fracture fixation…Some Thorecon disposable tensioners supplied in different Plating System Kits exhibit a molding defect which… | 09/10/2019Terminated |
| Z-0244-2020 Class II | A&E Medical Thorecon Plating System Kits Model No. 94-1400-04. For fracture fixation or…Some Thorecon disposable tensioners supplied in different Plating System Kits exhibit a molding defect which… | 09/10/2019Terminated |
| Z-0243-2020 Class II | A&E Medical Thorecon Plating System Kits Model No. 94-1300-04-S. For fracture fixation…Some Thorecon disposable tensioners supplied in different Plating System Kits exhibit a molding defect which… | 09/10/2019Terminated |
| Z-0242-2020 Class II | A&E Medical Thorecon Plating System Kits Model No. 94-1200-08. For fracture fixation or…Some Thorecon disposable tensioners supplied in different Plating System Kits exhibit a molding defect which… | 09/10/2019Terminated |
| Z-2098-2019 Class II | A&E Medical Corp. Ultra-Flex MYO/Wire Ultra-Flex Monopolar Pacing Wire Looped Electrode…Updated instructions for use: Ultra-Flex MYO/WIRE Monopolar pacing wire looped electrode (M-21 Series) to be… | 06/21/2019Terminated |
| Z-0813-2018 Class II | Surgical punch; sealed pouches packed in punch shelf box Intended for use by trained…Surgical punches are being recalled due to potential packaging damage which may have occurred during… | 10/23/2017Terminated |