InnoFine
JingFang Precision Medical Device(Shenzhen) Co., Ltd. · Model DEK-021 · UDI-DI 06971554726514
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 Samsung EA2-11B; Siemens EC9-4, EV9-4(ACUSON X150, X300, P500, OMNI, NX2, NX3; SONOLINE G40); Terason 8EC4A ultrasound transducers; 20g gel; 5x30cm latex cover, rubber bands.
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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