Regulatory Insight, Inc.

Regulatory Insight, Inc. holds 4 FDA 510(k) medical device clearances, first cleared 2002, most recent 2014, with 1 FDA device recall on record.

FDA recalls by Regulatory Insight, Inc.

Z-0753-2016 — GE Precision MPi is an all-digital multipurpose tilt-C x-ray system, intended for a multitude of diagnostic procedures, including radiology, fluoroscopy, interventional procedures, vascular and non-vascular procedures, and specialized applications including angiographic studies.Class II·Terminated·2008-07-01

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 Regulatory Insight, Inc.

K140780 — KEGEL SMART, KEGELSMART PEARLCode HIR·2014-09-10
K112505 — ETHEREACode GEX·2012-04-06
K020094 — EN 600-658, EN 600-666, EN 600-664, EN 600-690, EN 600-651, EN 600-663, EN 600-665 AND EN 600-670 MECHANICAL WHEELCHAIRSCode IOR·2002-03-08
K020100 — SL 803, SL 804, SL 807, SL 809, SL 506, SL 501, SL 805 AND SL 801 MECHANICAL WHEELCHAIRSCode IOR·2002-03-08

Data sourced from openFDA. This site is unofficial and independent of the FDA.

Top product codes for Regulatory Insight, Inc.

FDA recalls by Regulatory Insight, Inc.

Recent clearances by Regulatory Insight, Inc.