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FORMATK SYSTEMS LTD

4 clearances · 1 adverse events · aggregated across 4 source records

Scorecard
Events per device across the 84-device portfolio, trailing 12 months. Arrows compare the last 90 days with the 90 before.

MAUDE reports per device

0 →

0 in the last 12 months

Higher volume than 83% of companies with 10+ devices

Recalls per device

0 →

0 in the last 12 months

Higher volume than 97% of companies with 10+ devices

These are reporting-volume percentiles, not safety rankings — MAUDE counts have no denominator of devices in use, and recall attribution follows resolved links. A high percentile means more reports per registered device than peers, which can reflect market size, device criticality, or reporting practice as much as anything else.

Devices
84 device records · ordered by linked event volume.
BrandModelProduct codesPrimary DILinked events
ALDFS70001GEX072900166813212
AlphaFS90000GEX ONF072900166810622
HR-MaxFS80022GEX072900166814442
HR-MiniFS80021GEX072900166814372
LLDFS70007GEX072900166813452
MagmaFS70000GEX ONF072900166810242
Magma Spark PlusFS90000GEX ONF072900166810552
Magma Spark ProFS90000GEX ONF072900166810482
NDFS70002GEX072900166813382
B-HRFS10006ONF072900166812461
B-HR*FS10007ONF072900166812531
B-SRFS10008ONF072900166812601
DioBreezeFS80020GEX072900166810791
F-ACFS10005ONF072900166812391
F-HRFS10002ONF072900166812081
F-HR*FS10003ONF072900166812151
F-SRFS10004ONF072900166812221
FormaFS10000GFE ILY ONF PBX072900166810001
Forma LightFS60000ONF072900166810171
HRFS60002ONF072900166812841
HR*FS60003ONF072900166812911
Magma SparkFS80000GEX072900166810311
S-430FS90011ONF072900166813521
SRFS60001ONF072900166813071
STFS10011PBX072900166812771
Sheerwave PlusIPLaser 360GEX ONF072900166810861
ALD0
ALD0
ALPHA0
Alpha0
Showing 1–30 of 84Next →
Facilities
Registered establishments with their latest FDA inspection outcome.
FEINameLocationLast inspectionWatch
3011670002FORMATK SYSTEMS LTD.Tirat Hacarmel Northern, IL—