ClearanceBrief
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

DateFirm and productCodeLinked 510(k)
Dec 15, 2022DeRoyal Industries Inc
DeRoyal LAPAROSCOPIC ROBOTIC TRAY, REF 89-7063.11
Open, Classified
LRONone listed
Dec 15, 2022DeRoyal Industries Inc
DeRoyal BREAST TRAY, REF 89-7033.07
Open, Classified
LRONone listed
Dec 15, 2022DeRoyal Industries Inc
DeRoyal CANNULTED HIP PACK, REF 89-6977.10
Open, Classified
LRONone listed
Dec 15, 2022DeRoyal Industries Inc
DeRoyal CANNULTED HIP PACK CSM, REF 89-6977.09
Open, Classified
LRONone listed
Dec 15, 2022DeRoyal Industries Inc
DeRoyal CATARACT PACK CSM, REF 89-6863
Open, Classified
LRONone listed
Dec 15, 2022DeRoyal Industries Inc
DeRoyal SHOULDER PACK, REF 89-6830.13
Open, Classified
LRONone listed
Dec 15, 2022DeRoyal Industries Inc
GEO-MED TOTAL KNEE PACK A & B, REF 89-6799.02
Open, Classified
LRONone listed
Dec 15, 2022DeRoyal Industries Inc
GEO-MED PLASTIC HAND PACK RF, REF 89-6667.10
Open, Classified
LRONone listed
Dec 15, 2022DeRoyal Industries Inc
GEO-MED PLASTIC HAND PACK RF, REF 89-6667.09
Open, Classified
LRONone listed
Dec 15, 2022DeRoyal Industries Inc
DeRoyal OPEN SHOULDER PROCEDURE PACK RF, REF 89-6629.09
Open, Classified
LRONone listed
Dec 15, 2022DeRoyal Industries Inc
DeRoyal OPEN SHOULDER PROCEDURE PACK RF, REF 89-6629.07
Open, Classified
LRONone listed
Dec 15, 2022DeRoyal Industries Inc
DeRoyal SHOULDER ARTHORSCOPY PACK RF, REF 89-6628.09
Open, Classified
LRONone listed
Dec 15, 2022DeRoyal Industries Inc
GEO-MED OPTHALMOLOGY CSTM PCK, REF 89-6387.09
Open, Classified
LRONone listed
Dec 15, 2022DeRoyal Industries Inc
GEO-MED OPTHALMOLOGY CSTM PCK, REF 89-6387.08
Open, Classified
LRONone listed
Dec 15, 2022DeRoyal Industries Inc
GEO-MED PODIATRY PACK PGYBK, REF 89-6240.05
Open, Classified
LRONone listed
Dec 15, 2022DeRoyal Industries Inc
DeRoyal PICC LINE TRAY PGYBK, REF 89-6150.13
Open, Classified
LRONone listed
Dec 15, 2022DeRoyal Industries Inc
GEO-MED SHOULDER ARTHROSCOPY KNEE PACK, REF 89-5797.09
Open, Classified
LRONone listed
Dec 15, 2022DeRoyal Industries Inc
GEO-MED TOTAL KNEE PACK A & B PGYK, REF 89-5796.13
Open, Classified
LRONone listed
Dec 15, 2022DeRoyal Industries Inc
GEO-MED KNEE ARTHROSCOPY PACK, REF 89-5795.07
Open, Classified
LRONone listed
Dec 15, 2022DeRoyal Industries Inc
DeRoyal PEDI ORTHO PACK, REF 89-5323.20
Open, Classified
LRONone listed
Dec 15, 2022DeRoyal Industries Inc
DeRoyal EYE TRAY, REF 89-4957.08
Open, Classified
LRONone listed
Dec 15, 2022DeRoyal Industries Inc
DeRoyal EXTREMITY TRAY PGYBK, REF 89-4081.07
Open, Classified
LRONone listed
Dec 15, 2022DeRoyal Industries Inc
DeRoyal EYE PACK, REF 89-4051.09
Open, Classified
LRONone listed
Dec 15, 2022DeRoyal Industries Inc
DeRoyal MAJOR ORAL PACK RF, REF 89-3936.15
Open, Classified
LRONone listed
Dec 15, 2022DeRoyal Industries Inc
DeRoyal MINOR ORAL / ENT PACK, REF 89-2576.15
Open, Classified
LRONone listed
Dec 14, 2022Stradis Medical, LLC dba Stradis Healthcare
HENRY SCHEIN, Vas Pack, Item No.888-2520,
Open, Classified
LRONone listed
Dec 14, 2022Stradis Medical, LLC dba Stradis Healthcare
STRADIS HEALTHCARE, VENOUS ACCESS PACK, Item No.682-1993R1,
Open, Classified
LRONone listed
Dec 14, 2022Stradis Medical, LLC dba Stradis Healthcare
HENRY SCHEIN, Labiaplasty PackItem No.570-3118,
Open, Classified
LRONone listed
Dec 14, 2022Stradis Medical, LLC dba Stradis Healthcare
HENRY SCHEIN, CUSTOM PK 2, Item No.570-3072
Open, Classified
LRONone listed
Dec 14, 2022Stradis Medical, LLC dba Stradis Healthcare
HENRY SCHEIN, PROCEDURE TRAY, Item No.570-2900,
Open, Classified
LRONone listed
Dec 14, 2022Stradis Medical, LLC dba Stradis Healthcare
HENRY SCHEIN, BASIC EXTENDED PACK, Item No.570-2890
Open, Classified
LRONone listed
Dec 14, 2022Stradis Medical, LLC dba Stradis Healthcare
HENRY SCHEIN, TEMP STIMULATOR SUPPLIES, Item No.570-2883
Open, Classified
LRONone listed
Dec 14, 2022Stradis Medical, LLC dba Stradis Healthcare
HENRY SCHEIN, PACEMAKER PACK IItem No.570-2793
Open, Classified
LRONone listed
Dec 14, 2022Stradis Medical, LLC dba Stradis Healthcare
HENRY SCHEIN, UNIVERSAL TRAY, Item No.570-2787
Open, Classified
LRONone listed
Dec 14, 2022Stradis Medical, LLC dba Stradis Healthcare
HENRY SCHEIN, BASIC PACK, Item No.570-2719, UDI/DI (case) H65857027191, UDI/DI (kit)M75257027190, Serial/Lot Numbers: 22242489505
Open, Classified
LRONone listed
Dec 14, 2022Stradis Medical, LLC dba Stradis Healthcare
HENRY SCHEIN, Basin Set, Item No.570-1803
Open, Classified
LRONone listed
Dec 14, 2022Stradis Medical, LLC dba Stradis Healthcare
HENRY SCHEIN, Basin Pack, Item No.570-1692
Open, Classified
LRONone listed
Dec 14, 2022Stradis Medical, LLC dba Stradis Healthcare
HENRY SCHEIN, PROCEDURE KIT, Item No.570-1508, general surgery tray
Open, Classified
LRONone listed
Dec 14, 2022Stradis Medical, LLC dba Stradis Healthcare
HENRY SCHEIN, Novasure Pack, Item No.570-1462, general surgery tray
Open, Classified
LRONone listed
Dec 14, 2022Stradis Medical, LLC dba Stradis Healthcare
STRADIS HEALTHCARE, PROBE COVER W/GEL PACK, Item No.525-071, general surgery tray
Open, Classified
LRONone listed
Dec 14, 2022Stradis Medical, LLC dba Stradis Healthcare
STRADIS HEALTHCARE, SAFETY PINS, SMALL 1" Item No.515-001
Open, Classified
LRONone listed
Dec 1, 2022Alcon Research, LLC
Alcon Custom Pak Surgical Procedure Pack
Open, Classified
LROK880961
Nov 23, 2022ROi CPS LLC
regard MINOR DAVINCI PACK, GS00349M, Item Number 880251013; general surgery convenience kit
Terminated
LRONone listed
Nov 22, 2022American Contract Systems, Inc.
BASIN SET, MEBS42K, general surgical kit
Terminated
LRONone listed
Nov 1, 2022MEDLINE INDUSTRIES, LP - Northfield
MEDLINE CVC BARRIER KIT, REF DYNJ80485. Convenience kit used in medical procedures.
Open, Classified
LRONone listed
Nov 1, 2022MEDLINE INDUSTRIES, LP - Northfield
MEDLINE RADIOLOGY PROCEDURE PACK, REF DYNJ67150A. Convenience kit used in medical procedures.
Open, Classified
LRONone listed
Nov 1, 2022MEDLINE INDUSTRIES, LP - Northfield
MEDLINE DENTAL PACK, REF DYNJ66983. Convenience kit used in medical procedures.
Open, Classified
LRONone listed
Nov 1, 2022MEDLINE INDUSTRIES, LP - Northfield
MEDLINE LINQ TRAY, REF DYNJ65880A. Convenience kit used in medical/surgical procedures.
Open, Classified
LRONone listed
Nov 1, 2022MEDLINE INDUSTRIES, LP - Northfield
MEDLINE LITHOTOMY, REF DYNJ50099C. Convenience kit used in medical/surgical procedures.
Open, Classified
LRONone listed
Nov 1, 2022MEDLINE INDUSTRIES, LP - Northfield
BAUSCH + LOMB EYE PACK, REF LYN003EYSPA. Convenience kit used in surgical procedures.
Open, Classified
LRONone listed

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