Chrysalis Intelligence · Sponsors · Amd Medicom, Inc.

Amd Medicom, Inc.

Pointe-Claire, Montreal, CA · 1 510(k) clearances · 5 recalls

Total clearances
1
2020-01-17 → 2020-01-17
Last 12 months
0
Product codes
1
Most recent
2020-01-17
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
FYC Gown, Isolation, Surgical Class II General, Plastic Surgery 1 2020-01-17
Safety

Recalls (5)

Class I (serious)
0
Risk of injury / death
Total recalls
5
Currently ongoing
5
Most recent
2026-05-08
DateSeverityStatusRecall # ProductCodeReason
2026-05-08 Class II Ongoing Z-2459-2026 Ritmed Neurological Sponges, 0.75x0.75in, Sterile, REF: 85995C Neurological sponges used to moisten or absorb biological fluid during neurological surgery and may also be used to protect the brain during incision, may not c…
2026-05-08 Class II Ongoing Z-2458-2026 Ritmed Neurological Sponges, Description/REF: 0.5x0.5in, Non-Sterile/55992C; 0.5x1.0in, Non-Sterile/55993C; 0.5x3.… Neurological sponges used to moisten or absorb biological fluid during neurological surgery and may also be used to protect the brain during incision, may not c…
2023-12-21 Class II Ongoing Z-1148-2024 PATTERSON¿ PROCEDURE EARLOOP MASKS- ANTI-FOG, ASTM LEVEL 3 (BLUE) (item code 127-7573) Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products.
2023-12-21 Class II Ongoing Z-1147-2024 HENRY SCHEIN¿ CRITERION¿ ANTI-FOG EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-3281) Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products.
2023-12-21 Class II Ongoing Z-1146-2024 HENRY SCHEIN¿ CRITERION¿ EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-2448) Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products.
Filings

All 510(k) clearances (1)

Date K-number Device Code Class Specialty
2020-01-17 K190306 AMD Ritmed AssureWear VersaGown FYC Class II General, Plastic Surgery