Panels › General, Plastic Surgery › Product code LRO · Class 2

General Surgery Tray

Regulation 878.4370

0510(k)s in 12 months (110 all time)

101recalls in 12 months (1,082 all time)

141recalls that name a 510(k)

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Top companies in LRO

Company	510(k)s	Recalls
Customed, Inc.	6	232
Deroyal Industries, Inc.	1	192
Resource Optimization & Innovation Llc	0	139
AVID Medical, Inc.	0	122
Medline Industries, Inc.	5	84
MEDLINE INDUSTRIES, LP - Northfield	0	83
Stradis Healthcare, LLC.	0	51
Custom Healthcare Systems, Inc.	0	30
American Contract Systems	0	20
Cardinal Health	0	18

Date	Firm and product	Code	Linked 510(k)
Dec 15, 2022	DeRoyal Industries Inc DeRoyal TOTAL HIP PACK, REF 89-9113.06 Open, Classified	LRO	None listed
Dec 15, 2022	DeRoyal Industries Inc DeRoyal LAMINECTOMY SPINAL FUSION PACK, REF 89-9105.10 Open, Classified	LRO	None listed
Dec 15, 2022	DeRoyal Industries Inc DeRoyal LAMINECTOMY SPINAL FUSION PACK, REF 89-9105.09 Open, Classified	LRO	None listed
Dec 15, 2022	DeRoyal Industries Inc DeRoyal LAMINECTOMY SPINAL FUSION PACK, REF 89-9105.08 Open, Classified	LRO	None listed
Dec 15, 2022	DeRoyal Industries Inc DeRoyal KIT HEART B PACK, REF 89-9042.08 Open, Classified	LRO	None listed
Dec 15, 2022	DeRoyal Industries Inc DeRoyal KIT HEART B PACK, REF 89-9042.07 Open, Classified	LRO	None listed
Dec 15, 2022	DeRoyal Industries Inc DeRoyal KIT EXTREMITY PACK, REF 89-8869.09 Open, Classified	LRO	None listed
Dec 15, 2022	DeRoyal Industries Inc DeRoyal KIT TOTAL HIP, REF 89-8861.07 Open, Classified	LRO	None listed
Dec 15, 2022	DeRoyal Industries Inc DeRoyal TLIF PACK, REF 89-8780.04 Open, Classified	LRO	None listed
Dec 15, 2022	DeRoyal Industries Inc DeRoyal ACDF PACK, REF 89-8779.03 Open, Classified	LRO	None listed
Dec 15, 2022	DeRoyal Industries Inc DeRoyal SHOULDER ARTHROSCOPY PACK, REF 89-8777.04 Open, Classified	LRO	None listed
Dec 15, 2022	DeRoyal Industries Inc DeRoyal EYE PACK, REF 89-8756.03 Open, Classified	LRO	None listed
Dec 15, 2022	DeRoyal Industries Inc GEO-MED BIOPSY TRAY, REF 89-8753.01 Open, Classified	LRO	None listed
Dec 15, 2022	DeRoyal Industries Inc DeRoyal PORT PACK PGYBK, REF 89-8748.05 Open, Classified	LRO	None listed
Dec 15, 2022	DeRoyal Industries Inc GEO-MED PODIATRY PACK PGYBK, REF 89-8700.02 Open, Classified	LRO	None listed
Dec 15, 2022	DeRoyal Industries Inc GEO-MED PODIATRY PACK PGYBK, REF 89-8700.01 Open, Classified	LRO	None listed
Dec 15, 2022	DeRoyal Industries Inc DeRoyal BASIC PACK, REF 89-8633.07 Open, Classified	LRO	None listed
Dec 15, 2022	DeRoyal Industries Inc DeRoyal CUSTOM NEURO PACK, REF 89-8392.10 Open, Classified	LRO	None listed
Dec 15, 2022	DeRoyal Industries Inc DeRoyal CUSTOM NEURO PACK, REF 89-8392.09 Open, Classified	LRO	None listed
Dec 15, 2022	DeRoyal Industries Inc DeRoyal SPINE PACK, REF 89-8361.10 Open, Classified	LRO	None listed
Dec 15, 2022	DeRoyal Industries Inc DeRoyal SPINE PACK, REF 89-8361.09 Open, Classified	LRO	None listed
Dec 15, 2022	DeRoyal Industries Inc DeRoyal SPINE PACK, REF 89-8361.08 Open, Classified	LRO	None listed
Dec 15, 2022	DeRoyal Industries Inc DeRoyal PODIATRY PACK, REF 89-8359.13 Open, Classified	LRO	None listed
Dec 15, 2022	DeRoyal Industries Inc DeRoyal PODIATRY PACK, REF 89-8359.10 Open, Classified	LRO	None listed
Dec 15, 2022	DeRoyal Industries Inc DeRoyal HEART PACK, REF 89-8351.13 Open, Classified	LRO	None listed
Dec 15, 2022	DeRoyal Industries Inc DeRoyal HEART PACK, REF 89-8351.12 Open, Classified	LRO	None listed
Dec 15, 2022	DeRoyal Industries Inc DeRoyal HEART PACK, REF 89-8351.11 Open, Classified	LRO	None listed
Dec 15, 2022	DeRoyal Industries Inc DeRoyal BASIC EYE PACK, REF 89-8337.09 Open, Classified	LRO	None listed
Dec 15, 2022	DeRoyal Industries Inc DeRoyal BASIC EYE PACK, REF 89-8337.08 Open, Classified	LRO	None listed
Dec 15, 2022	DeRoyal Industries Inc GEO-MED UPPER EXTERMITY PACK, REF 89-8253.02 Open, Classified	LRO	None listed
Dec 15, 2022	DeRoyal Industries Inc GEO-MED LOWER EXTERMITY PACK, REF 89-8252.02 Open, Classified	LRO	None listed
Dec 15, 2022	DeRoyal Industries Inc DeRoyal EYE TRAY PGYBK, REF 89-7978.02 Open, Classified	LRO	None listed
Dec 15, 2022	DeRoyal Industries Inc DeRoyal ENDOVENOUS PACK, REF 89-7762.05 Open, Classified	LRO	None listed
Dec 15, 2022	DeRoyal Industries Inc DeRoyal ORTHO SPINE BACK PACK, REF 89-7534.09 Open, Classified	LRO	None listed
Dec 15, 2022	DeRoyal Industries Inc DeRoyal BASIC NEURO PACK, REF 89-7523.16 Open, Classified	LRO	None listed
Dec 15, 2022	DeRoyal Industries Inc DeRoyal BASIC NEURO PACK, REF 89-7523.15 Open, Classified	LRO	None listed
Dec 15, 2022	DeRoyal Industries Inc DeRoyal SPINAL FUSION PACK, REF 89-7515.14 Open, Classified	LRO	None listed
Dec 15, 2022	DeRoyal Industries Inc DeRoyal SPINAL FUSION PACK, REF 89-7515.13 Open, Classified	LRO	None listed
Dec 15, 2022	DeRoyal Industries Inc DeRoyal SPINAL FUSION PACK, REF 89-7515.12 Open, Classified	LRO	None listed
Dec 15, 2022	DeRoyal Industries Inc DeRoyal CUSTOM NEURO PACK, REF 89-7353.17 Open, Classified	LRO	None listed
Dec 15, 2022	DeRoyal Industries Inc DeRoyal RETINAL PACK, REF 89-7336.07 Open, Classified	LRO	None listed
Dec 15, 2022	DeRoyal Industries Inc DeRoyal VIT RD PACK 86ST, REF 89-7308.09 Open, Classified	LRO	None listed
Dec 15, 2022	DeRoyal Industries Inc DeRoyal BASIC NEURO PACK, REF 89-7258.13 Open, Classified	LRO	None listed
Dec 15, 2022	DeRoyal Industries Inc DeRoyal BASIC NEURO PACK, REF 89-7258.12 Open, Classified	LRO	None listed
Dec 15, 2022	DeRoyal Industries Inc DeRoyal BASIC NEURO PACK, REF 89-7258.10 Open, Classified	LRO	None listed
Dec 15, 2022	DeRoyal Industries Inc DeRoyal LAPINECTOMY PACK, REF 89-7198.11 Open, Classified	LRO	None listed
Dec 15, 2022	DeRoyal Industries Inc DeRoyal LAPINECTOMY PACK, REF 89-7198.10 Open, Classified	LRO	None listed
Dec 15, 2022	DeRoyal Industries Inc DeRoyal TRANS CANAL PACK, REF 89-7157.12 Open, Classified	LRO	None listed
Dec 15, 2022	DeRoyal Industries Inc DeRoyal CATARACT PACK, REF 89-7135.10 Open, Classified	LRO	None listed
Dec 15, 2022	DeRoyal Industries Inc DeRoyal GU ROBOTIC PACK, REF 89-7063.12 Open, Classified	LRO	None listed

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