SEDECAL

18 clearances · 12 adverse events · 3 inspections · 1 recalls

Scorecard

Events per device across the 208-device portfolio, trailing 12 months. Arrows compare the last 90 days with the 90 before.

MAUDE reports per device

0.005 →

1 in the last 12 months

Higher volume than 86% 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

208 device records · ordered by linked event volume.

Brand	Model	Product codes	Primary DI	Linked events
SEDECAL	SM-40HF-B-D-C	IZL MQB	08436046001510	55
SEDECAL	SM-20HF-Batt	IZL MQB	08436046001091	32
SEDECAL	SM-40HF-Batt	IZL MQB	08436046001114	32
SEDECAL	SM-32HF-B-D-C	IZL MQB	08436046001503	32
SEDECAL	SM-32HF-Batt	IZL MQB	08436046001466	32
SEDECAL	SM-20HF-B-D-C	IZL MQB	08436046001497	32
SEDECAL	SM-50HF-Batt	IZL MQB	08436046001121	31
SEDECAL	SM-40HF-B-D-VIR	IZL MQB	08436046002166	12
SEDECAL	Soltus 500	IZL MQB	08436046002456	11
Philips	MobileDiagnost wDR 2.2	IZL MQB	08436046002357	10
SEDECAL	Soltus 450	IZL MQB	08436046002555	6
SEDECAL	Soltus 450	IZL MQB	08436046002531	4
SEDECAL	Soltus 450	IZL MQB	08436046002548	4
SEDECAL	Soltus 450	IZL MQB	08436046002562	4
SEDECAL	Soltus 500	IZL MQB	08436046002463	3
SEDECAL	Radiographic System Challenge X	KPR MQB	08436046002388	3
SEDECAL	Soltus 500	IZL MQB	08436046002449	3
SEDECAL	SEDECAL X URS	KPR	08436046002500	3
SEDECAL	SHF-835	IZO	08436046000438	3
SEDECAL	SEDECAL X (URS)	KPR	08436046000933	3
SEDECAL	PhoeniX	IZL MQB	08436046003163	3
SEDECAL	Proteus XR/f ET	KPR MQB	08436046002302	2
SEDECAL	SM-50HF-B-D-C	IZO MQB	08436046001527	2
SEDECAL	AeroDR TX m01	IZL MQB	08436046003118	2
SEDECAL	AeroDR TX m01	IZL MQB	08436046003125	2
SEDECAL	AeroDR TX m01	IZL MQB	08436046003132	2
SEDECAL	PhoeniX	IZL MQB	08436046003156	2
SEDECAL	AeroDR TX m01	IZL MQB	08436046003101	2
SEDECAL	SM-V	IZL	08436046003040	2
SEDECAL	Proteus XR/f ET	KPR MQB	08436046003033	2

Showing 1–30 of 208Next →

Facilities

Registered establishments with their latest FDA inspection outcome.

No registered facilities linked.