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InnoFine

JingFang Precision Medical Device(Shenzhen) Co., Ltd. · Model JSM-049 · UDI-DI 06971554721762

OIJ Prescription
0
510(k) clearances
1
Adverse events
2
Recalls
34
Facilities

Description

Reusable Needle Guides for use with Unimaging L12-5, L10-5;Qsono L11-4DS;Sonosray L13-5;Welld 12L5A;FocusFusion L12-5;RICSO L40;BMV 7L4C;DAWEI L5-12A, L5-12S;Zoncare 7L4CD;Lanmage L10-5;Cansonic L10-5s;SonoLepu 7L4C; ULTRAST L38H10 Ultrasound Transducers

Recalls

DateFirmReason
2017-07-07Hologic, Inc.The firm is implementing a product correction involving its Affirm Lateral Arm Upright Biopsy Accessory, ASY-09880. The correction has been initiated due to a component (the Left-h
2016-05-19Devicor Medical Products IncA 10 Gauge needle, 9cm long was shipped in an 8 Gauge needle, 15 cm package.

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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.