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 CRANI PACK, REF 89-10242.04 Open, Classified	LRO	None listed
Dec 15, 2022	DeRoyal Industries Inc DeRoyal CRANI PACK, REF 89-10242.02 Open, Classified	LRO	None listed
Dec 15, 2022	DeRoyal Industries Inc DeRoyal SHOULDER ARTHOSCOPY PACK, REF 89-10240.03 Open, Classified	LRO	None listed
Dec 15, 2022	DeRoyal Industries Inc DeRoyal PACEMAKER ICD PACK, REF 89-10216.06 Open, Classified	LRO	None listed
Dec 15, 2022	DeRoyal Industries Inc DeRoyal PACEMAKER ICD PACK, REF 89-10216.03 Open, Classified	LRO	None listed
Dec 15, 2022	DeRoyal Industries Inc DeRoyal LUMBAR FUSION PACK, REF 89-10211.05 Open, Classified	LRO	None listed
Dec 15, 2022	DeRoyal Industries Inc DeRoyal LAMINECTOMY PACK, REF 89-10209.02 Open, Classified	LRO	None listed
Dec 15, 2022	DeRoyal Industries Inc DeRoyal CRANI PACK, REF 89-10202.05 Open, Classified	LRO	None listed
Dec 15, 2022	DeRoyal Industries Inc DeRoyal CRANI PACK, REF 89-10202.03 Open, Classified	LRO	None listed
Dec 15, 2022	DeRoyal Industries Inc DeRoyal NEURO PACK, REF 89-10171.06 Open, Classified	LRO	None listed
Dec 15, 2022	DeRoyal Industries Inc DeRoyal NEURO PACK, REF 89-10171.05 Open, Classified	LRO	None listed
Dec 15, 2022	DeRoyal Industries Inc DeRoyal NEURO PACK, REF 89-10171.03 Open, Classified	LRO	None listed
Dec 15, 2022	DeRoyal Industries Inc DeRoyal TOTAL SHOULDER PACK, REF 89-10151.05 Open, Classified	LRO	None listed
Dec 15, 2022	DeRoyal Industries Inc DeRoyal SHOULDER ARTHOSCOPY PACK, REF 89-10061.02 Open, Classified	LRO	None listed
Dec 15, 2022	DeRoyal Industries Inc DeRoyal POSTERIOR LUMBAR FUSION PACK, REF 89-10060.02 Open, Classified	LRO	None listed
Dec 15, 2022	DeRoyal Industries Inc DeRoyal POSTERIOR LAMI MICRODISC PACK, REF 89-10059.02 Open, Classified	LRO	None listed
Dec 15, 2022	DeRoyal Industries Inc DeRoyal FACIAL PACK PGYBK, REF 89-10007.03 Open, Classified	LRO	None listed
Dec 15, 2022	DeRoyal Industries Inc DeRoyal ACDF PACK PGYBK A PACK / B PACK, REF 89-9997.06 Open, Classified	LRO	None listed
Dec 15, 2022	DeRoyal Industries Inc DeRoyal SHOULDER ARTHOSCOPY PACK, REF 89-9946.04 Open, Classified	LRO	None listed
Dec 15, 2022	DeRoyal Industries Inc DeRoyal BIOPSY PACK, REF 89-9739.06 Open, Classified	LRO	None listed
Dec 15, 2022	DeRoyal Industries Inc DeRoyal BIOPSY PACK, REF 89-9739.05 Open, Classified	LRO	None listed
Dec 15, 2022	DeRoyal Industries Inc DeRoyal BREAST AUGMENTATION PACK, REF 89-9618.05 Open, Classified	LRO	None listed
Dec 15, 2022	DeRoyal Industries Inc DeRoyal BIOPSY PACK, REF 89-9614.07 Open, Classified	LRO	None listed
Dec 15, 2022	DeRoyal Industries Inc DeRoyal UNIVERSAL PACK, REF 89-9558.03 Open, Classified	LRO	None listed
Dec 15, 2022	DeRoyal Industries Inc DeRoyal ABDOMINOPLASTY W/LIPO PACK, REF 89-9557.03 Open, Classified	LRO	None listed
Dec 15, 2022	DeRoyal Industries Inc DeRoyal LUMBAR/CERVICAL PACK, REF 89-9521.11 Open, Classified	LRO	None listed
Dec 15, 2022	DeRoyal Industries Inc DeRoyal TOTAL HIP KIT, REF 89-9498.10 Open, Classified	LRO	None listed
Dec 15, 2022	DeRoyal Industries Inc DeRoyal TOTAL HIP KIT, REF 89-9498.08 Open, Classified	LRO	None listed
Dec 15, 2022	DeRoyal Industries Inc DeRoyal SHOULDER KIT, REF 89-9497.10 Open, Classified	LRO	None listed
Dec 15, 2022	DeRoyal Industries Inc DeRoyal SHOULDER KIT, REF 89-9497.08 Open, Classified	LRO	None listed
Dec 15, 2022	DeRoyal Industries Inc DeRoyal EMERGENT TRAUMA PACK, REF 89-9453.14 Open, Classified	LRO	None listed
Dec 15, 2022	DeRoyal Industries Inc DeRoyal EMERGENT TRAUMA PACK, REF 89-9453.13 Open, Classified	LRO	None listed
Dec 15, 2022	DeRoyal Industries Inc DeRoyal EMERGENT TRAUMA PACK, ref 89-9453.12 Open, Classified	LRO	None listed
Dec 15, 2022	DeRoyal Industries Inc DeRoyal SHOULDER PACK, REF 89-9449.13 Open, Classified	LRO	None listed
Dec 15, 2022	DeRoyal Industries Inc DeRoyal SHOULDER PACK, REF 89-9449.12 Open, Classified	LRO	None listed
Dec 15, 2022	DeRoyal Industries Inc DeRoyal ENDOVASCULAR TRACEPACK, REF 89-9350.03 Open, Classified	LRO	None listed
Dec 15, 2022	DeRoyal Industries Inc DeRoyal MYELOGRAM PACK, REF 89-9304.06 Open, Classified	LRO	None listed
Dec 15, 2022	DeRoyal Industries Inc DeRoyal MYELOGRAM PACK, REF 89-9304.05 Open, Classified	LRO	None listed
Dec 15, 2022	DeRoyal Industries Inc DeRoyal TOTAL HIP PACK, REF 89-9301.07 Open, Classified	LRO	None listed
Dec 15, 2022	DeRoyal Industries Inc DeRoyal TOTAL KNEE PACK, REF 89-9300.08 Open, Classified	LRO	None listed
Dec 15, 2022	DeRoyal Industries Inc DeRoyal BIOPSY PACK, REF 89-9270.05 Open, Classified	LRO	None listed
Dec 15, 2022	DeRoyal Industries Inc DeRoyal BIOPSY PACK, REF 89-9270.04 Open, Classified	LRO	None listed
Dec 15, 2022	DeRoyal Industries Inc DeRoyal NEURO PACK, REF 89-9253.09 Open, Classified	LRO	None listed
Dec 15, 2022	DeRoyal Industries Inc DeRoyal NEURO PACK, REF 89-9253.07 Open, Classified	LRO	None listed
Dec 15, 2022	DeRoyal Industries Inc DeRoyal FOOT PACK, REF 89-9252.08 Open, Classified	LRO	None listed
Dec 15, 2022	DeRoyal Industries Inc DeRoyal FOOT PACK, REF 89-9252.07 Open, Classified	LRO	None listed
Dec 15, 2022	DeRoyal Industries Inc DeRoyal FOOT PACK, REF 89-9252.06 Open, Classified	LRO	None listed
Dec 15, 2022	DeRoyal Industries Inc DeRoyal MAJOR ORTHO PACK, REF 89-9250.07 Open, Classified	LRO	None listed
Dec 15, 2022	DeRoyal Industries Inc DeRoyal BASIC EYE PACK, REF 89-9233.08 Open, Classified	LRO	None listed
Dec 15, 2022	DeRoyal Industries Inc DeRoyal TOTAL HIP PACK, REF 89-9113.07 Open, Classified	LRO	None listed

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