Sedecal., Sa.
Sedecal., Sa. holds FDA 510(k) medical device clearances, first cleared 2002, most recent 2023, with 53 FDA device recalls on record.
Top product codes for Sedecal., Sa.
FDA recalls by Sedecal., Sa.
10 most recent of 53- Z-0267-2026 — Model Number SM-40HF-B-D-C; 40KW 55G, Mobile X-ray system
- Z-0272-2026 — Model Number SM-40HF-B-D-C; 40KW 70C EN, Mobile X-ray system
- Z-0248-2026 — Model Number 40KWFXPLUS.004, Mobile X-ray system
- Z-0279-2026 — Model Number SM-40HF-B-D-C; 40KW.005, Mobile X-ray system
- Z-0273-2026 — Model Number SM-40HF-B-D-C; 40KW 70C READY, Mobile X-ray system
- Z-0278-2026 — Model Number SM-40HF-B-D-C; 40KW.002, Mobile X-ray system
- Z-0281-2026 — RADPRO MOBILE, Mobile X-ray system
- Z-0249-2026 — Model Number 40KWFXPLUS.005, Mobile X-ray system
- Z-0269-2026 — Model Number SM-40HF-B-D-C; 40KW 55C, Mobile X-ray system
- Z-0264-2026 — Model Number SM-40HF-B-D-C; 40KW 50G, Mobile X-ray system
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Sedecal., Sa.
- K232185 — SM-IV
- K222951 — SM-V
- K221803 — PHOENIX/AeroDR TX m01 and PHOENIX/mKDR Xpress.
- K212291 — PHOENIX
- K203537 — Proteus XR/f, Models ST and ET, Multirad and Multirad NET Radiographic Systems
- K202293 — Radiographic System Challenge X
- K192936 — Soltus 500
- K192011 — PhoeniX
- K191813 — MobileDiagnost wDR 2.2
- K173299 — DRAGON X SPSL4HC, DRAGON X SPSL8HC
- K161345 — RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIR
- K141895 — MOBILEDIAGNOST WDR
- K133782 — NOVA FA DR SYSTEM
- K130883 — SEDECAL DIGITAL RADIOGRAPHIC UPGRADE MODEL SDRU-T
- K121410 — DRAGON LW
- K101517 — SEDECAL MOBILE DIGITAL DIAGNOSTIC X-RAY
- K111725 — MOBILEDIAGNOST WDR
- K103522 — SEDECAL
- K090322 — EASY MOVING PLUS, SM-XXHF-YY
- K090279 — SEDECAL, MILLENNIUM PLUS
- K090238 — SEDECAL X-PLUS LP PLUS DIGITAL DIAGNOSTIC X-RAY SYSTEMS
- K063283 — DEFINIUM 5000 X-RAY SYSTEM
- K062335 — SEDECAL X PLUS LP PLUS
- K042876 — URS LP DIGITAL, MILLENNIUM, RADPRO
- K043002 — SEDECAL MOBILE X-RAY UNITS WITH DIGITAL DETECTOR
- K020436 — PORTABLE X-RAY UNITS; MODELS SP-HF-2.8 & SP-HF-4.0
Data sourced from openFDA. This site is unofficial and independent of the FDA.