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iSR'obot Kit

BIOBOT SURGICAL PTE. LTD. · Model iSR'obot Kit - 14G · UDI-DI 08885014610207

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

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.