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InnoFine

JingFang Precision Medical Device(Shenzhen) Co., Ltd. · Model DE-001 · UDI-DI 06971554725012

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510(k) clearances

Adverse events

Recalls

Facilities

Description

Disposable Needle Guides for use with Mindray 65EC10EA, 6CV1(s,P), CB10-4(s,P,E), V10-4(s), V10-4B(s,p), V11-3(E), V11-3B(E), V11-3W(s,E), V11-3H(E,U); Wisonic EV10-4; Landwind EC4-9; Samsung EC4-9IS, EC4-9ES, ER4-9ES; GE IC5-9; VINNO G4-9E, X4-9E; Zoncare 6E1CD Ultrasound Transducers

Recalls

Date	Firm	Reason
2017-07-07	Hologic, 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
2016-05-19	Devicor Medical Products Inc	A 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.