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SIM™ pod

SIMAVITA (AUST) PTY LTD · Model 6019 · UDI-DI 09342124000346

KPN
1
510(k) clearances
965
Adverse events (1 deaths)
4
Recalls
19
Facilities

Recalls

DateFirmReason
2022-09-30Baxter Healthcare CorporationRadio frequency emission from a functioning WatchCare device may potentially impact other devices (including, but not limited to telemetry devices, bladder scanner, fetal monitor/d
2022-09-30Baxter Healthcare CorporationRadio frequency emission from a functioning WatchCare device may potentially impact other devices (including, but not limited to telemetry devices, bladder scanner, fetal monitor/d
2022-09-30Baxter Healthcare CorporationRadio frequency emission from a functioning WatchCare device may potentially impact other devices (including, but not limited to telemetry devices, bladder scanner, fetal monitor/d
2022-09-30Baxter Healthcare CorporationRadio frequency emission from a functioning WatchCare device may potentially impact other devices (including, but not limited to telemetry devices, bladder scanner, fetal monitor/d

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.