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InnoFine

JingFang Precision Medical Device(Shenzhen) Co., Ltd. · Model JEM-028 · UDI-DI 06971554720017

OIJ Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

Reusable Needle Guides for use with Mindray 65EC10(EA,EB,EC,ED,HA),6CV1(s,P),CB10-4(s,P,E,A),V10-4(s),V10-4B(s,P),V11-3(E,s),V11-3B(E),V11-3W(s,E),E9-3,V11-3H(E,U,s); Lanmage EC4-9(Y),EC3-11; VINNO G4-9E; Zoncare 6E1CD; Hisense E9-4B,E9-4E; Krinwave EC5(v); COMEN E3-11H; Wisonic EV10-4, EV11-3-H; Esaote E8-5; ULTRAST R10H6 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.