InnoFine
JingFang Precision Medical Device(Shenzhen) Co., Ltd. · Model JEM-011 · UDI-DI 06971554720864
OIJ
Prescription
0
510(k) clearances
1
Adverse events
2
Recalls
34
Facilities
Description
Reusable Needle Guides for use with Siemens EC-10C5, EC9-4, EV9-4(ACUSON X500; SONOLINE G20, G50, G60 S); Samsung EC4-9IS, EC4-9ES, ER4-9ES; GE Healthcare IC5-9; Terason 8EC4(V) 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. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
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.