Alto Development Corp

FDA Regulatory Profile

Summary

Total Recalls
7
510(k) Clearances
10
Inspections
4
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0245-2020Class IIA&E Medical Thorecon Plating System Kits Model No. 94-1500-04-S. For fracture fixation or reconstruSeptember 10, 2019
Z-0242-2020Class IIA&E Medical Thorecon Plating System Kits Model No. 94-1200-08. For fracture fixation or reconstructSeptember 10, 2019
Z-0244-2020Class IIA&E Medical Thorecon Plating System Kits Model No. 94-1400-04. For fracture fixation or reconstructSeptember 10, 2019
Z-0243-2020Class IIA&E Medical Thorecon Plating System Kits Model No. 94-1300-04-S. For fracture fixation or reconstruSeptember 10, 2019
Z-0246-2020Class IIA&E Medical Thorecon Plating System Kits Model No. 94-1700-10. For fracture fixation or reconstructSeptember 10, 2019
Z-2098-2019Class IIA&E Medical Corp. Ultra-Flex MYO/Wire Ultra-Flex Monopolar Pacing Wire Looped Electrode (M-21 SERIESJune 21, 2019
Z-0813-2018Class IISurgical punch; sealed pouches packed in punch shelf box Intended for use by trained surgeons toOctober 23, 2017

Recent 510(k) Clearances

K-NumberDeviceDate
K964621A & E MEDICAL ELECTROCAUTERY SUCTION TUBE WITH FINGER TIP ACTIVATOR BUTTONDecember 20, 1996
K932513LABELING FOR MYO/WIRE II STERNOTOMY SUTURESJanuary 7, 1994
K931537A&E MEDICAL ELECTROSURG ELECTRO W/NON-STICK COATSeptember 7, 1993
K930528A&E MEDICAL ELECTROSURGICAL CONNECTING CORDSMay 17, 1993
K914193A&E MEDICAL CORP DISPOS SUCT COAG W/NON STICK COATOctober 5, 1992
K915300A & EM MEDICAL ELECTROSURGICAL PENCIL/ACCESSORIESFebruary 18, 1992
K884783RANEY CLIPNovember 30, 1988
K881413ELECTRO-CAUTERY SUCTION TUBEApril 21, 1988
K831867PRESSURE MONITORING IV BOTTLE CAPAugust 12, 1983
K821518MYO/CLIPJuly 8, 1982