InnoFine
JingFang Precision Medical Device(Shenzhen) Co., Ltd. · Model JEM-038 · UDI-DI 06971554722615
OIJ
Prescription
0
510(k) clearances
1
Adverse events
2
Recalls
34
Facilities
Description
Reusable Needle Guides for use with Qsono E10-4Cs; Unimaging EV9-4; yonker 6E1C; SonoStar 6E1C,6E1A-A; FocusFusion EC9-4; Sonomedic E10-4Cs; DAWEI C4-9A,EV9-4,C4-9R10; Zoncare 6E1CDS; Youkey E10-4Ks; Karchun EC9-4; HEYO HY9E10; ULTRAST R10E; Carbon 8EC4AN 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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Get your free API keyRead the docsData 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.