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InnoFine

JingFang Precision Medical Device(Shenzhen) Co., Ltd. · Model DEK-001 · UDI-DI 06971554726316

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

Description

Disposable Needle Guides Kit for endocavity biopsy, contents: Needle guide use with |Mindray| 65EC10(EA,EB,EC,ED,HA), 65EB10EA, 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); |Wisonic| EV10-4, EV11-3-H; |Landwind| EC4-9; |Samsung| EC4-9IS, EC4-9ES, ER4-9ES; |GE Healthcare| IC5-9; |VINNO| G4-9E, X4-9E, F4-9E; |Zoncare| 6E1CD ultrasound transducers; 20g gel; 5x30cm latex cover, rubber bands.

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.