International Biophysics Corp.
International Biophysics Corp. holds FDA 510(k) medical device clearances, first cleared 1996, most recent 2008, with 3 FDA device recalls on record.
Top product codes for International Biophysics Corp.
FDA recalls by International Biophysics Corp.
- Z-2423-2015 — IBC Aortic Punch Catalog Numbers APM40, APL48A, APM44A, APL40A, APM40A, CVAPL36, CVAPL40, CVAPL44, CVAPL48, CVAPL52, APM28BM, APM36BM, APM40BM, APM44BM, APM48BM, APM40BK, APM48BK, APM36BK, APM44BK, APM28, APM36, APL44, APM40 Product Usage: The IBC Aortic Punch is a single-use, disposable surgical punch used to create an opening in the wall of the aorta to prepare a site for anastomosis.
- Z-2422-2015 — IBC Suction Wand Catalog Number 1990S Product Usage: The IBC Suction Wand is a component of Blood Recovery System for use in open heart procedures, autologous blood recovery and blood suction. It is a disposable, single use component.
- Z-2424-2015 — IBC Vascular Loop Catalog Number CH111, CH112, CH113, CH114, CH115, CH116, CH118 Product Usage: The IBC Vascular Loop is a single-use, disposable loop used in occluding, retracting, and identifying arteries, veins, tendons, and nerves in surgical procedures.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by International Biophysics Corp.
- K072688 — LIFECHOICE OXYGEN CONCENTRATOR, MODEL OXY1000
- K030181 — INTERNATIONAL BIOPHYSICS CORPORATION (IBC) LASER PEEL SYSTEM
- K992657 — IBC VRV, MODEL 1350
- K992785 — IBC FLOGUARD, MODEL 6050
- K992964 — IBC VENT VALVE, MODEL 1400
- K983272 — IBC FLOPUMP, MODEL 6000
- K963703 — ACCUFLO MONITORING SYSTEM (1800)/ ACCUFLO PROBE (8000)
- K963756 — IBC CARDIAC SUCTION WARD
- K963698 — CM02 CUVETTE, 1/2, CM02 CUVETTE, 3/8 AND CM02 CUVETTE, 1/4
- K955379 — IBC GAS CELL COMPONENTS (1/2, 3/8, 1/4)
- K955380 — IBC QUICK CELL COMPONENT (1/2, 3/8, 1/4)
Data sourced from openFDA. This site is unofficial and independent of the FDA.