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Medicrea International

14 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Medicrea, IB3D Universal Implant Inserter, Rx Only REF: A24000000 recall (Z-1038-2026)Medicrea International2026-01-09
Medicrea, IB3D PL Instruments Set, Rx Only REF: SPS03174 recall (Z-1039-2026)Medicrea International2026-01-09
UNiD" Adaptive Spine Intelligence UNiD Spine Analyzer Product Number SW3002 UDI-DI code 03 recall (Z-1118-2025)Medicrea International2025-02-07
IMPIX 3D, REF numbers: a) B242C09122810, b) B242C10062810, c) B242C10122810, d) B242C11062 recall (Z-2452-2023)Medicrea International2023-08-24
IMPIX ALIF, REF numbers: a) B15111209, b) B15111212, c) B15111409, d) B15111412; intervert recall (Z-2453-2023)Medicrea International2023-08-24
IMPIX ALIF S/A, REF number B15241415; intervertebral fusion device - lumbar recall (Z-2454-2023)Medicrea International2023-08-24
IMPIX DLIF, REF numbers: a) B16123509, b) B16123511, c) B16124009, d) B16124013, e) B16124 recall (Z-2455-2023)Medicrea International2023-08-24
IMPIX MANTA, REF numbers: a) A20150407, b) A20250407, c) A20350567, d) B20181743, e) B2018 recall (Z-2456-2023)Medicrea International2023-08-24
IMPIX TLIF, REF numbers: a) B15130607S, b) B15130609S, c) B15130611S, d) B15130613S, e) B1 recall (Z-2457-2023)Medicrea International2023-08-24
PASS LP, REF numbers: a) B02315535Z, b) B02315540Z, c) B02315545Z, d) B02315550Z, e) B0231 recall (Z-2458-2023)Medicrea International2023-08-24
GRANVIA-C, REF numbers: a) A13111427, b) A13112567, c) A13113456, d) A13131516, e) A131317 recall (Z-2459-2023)Medicrea International2023-08-24
IMPIX C+, REF numbers: a) B20240104, b) B20240105, c) B20240106, d) B20240107, e) B2024020 recall (Z-2460-2023)Medicrea International2023-08-24
IMPIX S, REF numbers: a) B15328071S, b) B15328073S, c) B15328074S, d) B15334072S, e) B1533 recall (Z-2461-2023)Medicrea International2023-08-24
IMPIX MANTA+, REF numbers: a) B20171743, b) B20171753, c) B20171763, d) B20171773, e) B201 recall (Z-2462-2023)Medicrea International2023-08-24

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Every clearance here is in the API, with alerts when new ones post.