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)
Jul 20, 2023MEDLINE INDUSTRIES, LP - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) VEIN KIT, Model Number DYNJ55841B; b) FACELIFT PACK, Model Number DYNJ55954B; c) CLOT RETRIEVAL PACK, Model
Open, Classified
LRONone listed
Jul 20, 2023MEDLINE INDUSTRIES, LP - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) NO-CATH RADIAL ARTERIAL PREMIU, Model Number ARTNC115; b) MAJOR VASCULAR, Model Number CDS980752I; c) PICC
Open, Classified
LRONone listed
Jul 12, 2023MEDLINE INDUSTRIES, LP - Northfield
MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: a) TOTAL JOINT, Model Number CDS985555S; b) TOTAL KNEE, Model Number CDS985566Q; c) MAJOR ORTHO-LF, Model Number DYNJ0949139I; d) BSHR T
Open, Classified
LRONone listed
Jul 12, 2023MEDLINE INDUSTRIES, LP - Northfield
MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: a) OCULOPLASTY PACK, Model Number DYNJ64572A; b) EYE PACK, Model Number VAL050EEPKB
Open, Classified
LRONone listed
Jul 12, 2023MEDLINE INDUSTRIES, LP - Northfield
MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: HYSTERO PACK, Model Number DYNJ61448A
Open, Classified
LRONone listed
Jul 12, 2023MEDLINE INDUSTRIES, LP - Northfield
MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: OISC HAND BEAR, Model Number DYNJ902348L
Open, Classified
LRONone listed
Jul 12, 2023MEDLINE INDUSTRIES, LP - Northfield
MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: TOTAL KNEE THEDA, Model Number DYNJ908683A
Open, Classified
LRONone listed
Jul 12, 2023MEDLINE INDUSTRIES, LP - Northfield
MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: EAR CDS, Model Number CDS980089O
Open, Classified
LRONone listed
Jul 12, 2023MEDLINE INDUSTRIES, LP - Northfield
MEDLINE NON-STERILE PVP SOLUTION, STERILE PACKAGING REF DYNDA2232A
Open, Classified
LRONone listed
Jul 3, 2023DeRoyal Industries Inc
Custom medical procedure packs labeled as: a) OPEN HEART TRACECART, REF '53-1941; b) CARDIAC CATH PACK, REF '89-10045; c) SHOULDER PACK, REF '89-10115; d) MINOR ORTHO PACK, REF '89-10213; e) T
Open, Classified
LROK842648
Jun 7, 2023DeRoyal Industries Inc
Sterile custom surgical procedure packs: (1) 89-10507.02, TOTAL KNEE PACK, Stonewall Jackson Hospital; (2) 89-10508.02, LOCAL PACK, Stonewall Jackson Hospital; (3) 89-10509.02, LAPAROTOMY PACK, Stone
Open, Classified
LROK842648
Apr 25, 2023ROi CPS LLC
Sterile surgical convenience kits: 1. regard Item Number: 880353009, GS00797I - Laparotomy Pk; 2. regard Item Number: 880429002, GS01036B - Universal Custom ; 3. regard Item Number: 800725004,
Open, Classified
LRONone listed
Mar 28, 2023Alcon Research, LLC
Alcon Custom Pak Surgical Procedure Pack: Pak Number & Pak Description: 17533-04 DR GROSS LPS LLC 18704-03 CATARACT SURGI CARE 18382-03 DR GEORGE ZAMBELLI BEAVER VALLEY ASC 8685-21 CATARACT PACK EYE S
Open, Classified
LROK880961
Feb 23, 2023MEDLINE INDUSTRIES, LP - Northfield
(1) Medline Sterile Maximum Barrier Pack-LF, Item DYNJ0248546C, 6 kits per case, contains BD Chloraprep Hi-Lite Orange, 10.5 mL Applicator, Vendor PN: 930715NS; (2) Medline Sterile Maximum Barrier Pa
Open, Classified
LRONone listed
Feb 10, 2023MEDLINE INDUSTRIES, LP - Northfield
Surgical convenience kits labeled as: a) MEDLINE GENERAL UTILITY, Reorder Number DYNDA2524 b) CENTURION MEDICAL PRODUCTS DIALYSIS ON/OFF BUNDLE, Reorder Number DT22705A c) CENTURION MEDICAL PRODUC
Open, Classified
LRONone listed
Feb 6, 2023MEDLINE INDUSTRIES, LP - Northfield
Sterile Procedural Trays, labeled as the following: a. BASIN SET-UP PACK b. LAP CHOLE CDS c. MAJOR CDS d. UROLOGY MINOR CDS e. UROLOGY MAJOR CDS f. SINGLE BASIC CDS g. ORGAN RECOVERY CDS h. GENERAL
Open, Classified
LRONone listed
Jan 27, 2023MEDLINE INDUSTRIES, LP - Northfield
Non-sterile procedural trays labeled as MAJOR/MINOR, 3 per case
Open, Classified
LRONone listed
Jan 9, 2023DeRoyal Industries Inc
DeRoyal ORGAN RECOVERY PACK PGYBK, a) REF 89-9004.09 and b) 89-9004.10
Terminated
LROK842648
Jan 5, 2023DeRoyal Industries Inc
DeRoyal Tonsillectomy Tray, REF 89-10698.01
Terminated
LRONone listed
Dec 15, 2022DeRoyal Industries Inc
DeRoyal CATARACT PACK, REF 89-10086.05
Open, Classified
LRONone listed
Dec 15, 2022DeRoyal Industries Inc
DeRoyal CATARACT PACK, REF 89-10040.01
Open, Classified
LRONone listed
Dec 15, 2022DeRoyal Industries Inc
DeRoyal CATARACT PACK, REF 89-9241.04
Open, Classified
LRONone listed
Dec 15, 2022DeRoyal Industries Inc
DeRoyal CATARACT PACK, REF 89-9241.03
Open, Classified
LRONone listed
Dec 15, 2022DeRoyal Industries Inc
DeRoyal CATARACT PACK, REF 89-8859.08
Open, Classified
LRONone listed
Dec 15, 2022DeRoyal Industries Inc
DeRoyal CATARACT PACK, REF 89-8650.10
Open, Classified
LRONone listed
Dec 15, 2022DeRoyal Industries Inc
GEO-MED CATARACT PACK, REF 89-5790.08
Open, Classified
LRONone listed
Dec 15, 2022DeRoyal Industries Inc
DeRoyal TRACECART POSTEROR LAMI MICRODISC TRACECART, REF 53-1960.02
Open, Classified
LRONone listed
Dec 15, 2022DeRoyal Industries Inc
DeRoyal TRACECART POSTEROR LUMBAR FUSION TRACECART, REF 53-1961.02
Open, Classified
LRONone listed
Dec 15, 2022DeRoyal Industries Inc
DeRoyal TRACECART SHOULDER ARTHROSCOPY TRACECART, REF 53-1962.02
Open, Classified
LRONone listed
Dec 15, 2022DeRoyal Industries Inc
DeRoyal BIOPSY PACKPACK, REF 89-9756.05
Open, Classified
LRONone listed
Dec 15, 2022DeRoyal Industries Inc
DeRoyal TOTAL KNEE PACK A & B PACK, REF 89-6799.02
Open, Classified
LRONone listed
Dec 15, 2022DeRoyal Industries Inc
DeRoyal PACEMAKER ICD PACK, REF 89-10902.01
Open, Classified
LRONone listed
Dec 15, 2022DeRoyal Industries Inc
DeRoyal NEURO SPINE BACK PACK PGYBK, REF 89-10853.01
Open, Classified
LRONone listed
Dec 15, 2022DeRoyal Industries Inc
DeRoyal SHOULDER ARTHOSCOPY PACK, REF 89-10820.02
Open, Classified
LRONone listed
Dec 15, 2022DeRoyal Industries Inc
GEO-MED LOCAL ANESTHESIA PACK, REF 89-10800.01
Open, Classified
LRONone listed
Dec 15, 2022DeRoyal Industries Inc
DeRoyal LAMI/CRANI PACK, REF 89-10787.01
Open, Classified
LRONone listed
Dec 15, 2022DeRoyal Industries Inc
DeRoyal NEURO PACK, REF 89-10682.02
Open, Classified
LRONone listed
Dec 15, 2022DeRoyal Industries Inc
DeRoyal GU PACK, REF 89-10665.03
Open, Classified
LRONone listed
Dec 15, 2022DeRoyal Industries Inc
DeRoyal GU PACK, REF 89-10665.02
Open, Classified
LRONone listed
Dec 15, 2022DeRoyal Industries Inc
DeRoyal ANTERIOR APPROACH TOTAL HIP A&B PGYBK, REF 89-10612.01
Open, Classified
LRONone listed
Dec 15, 2022DeRoyal Industries Inc
DeRoyal LUMBAR DISC PACK, REF 89-10605.02
Open, Classified
LRONone listed
Dec 15, 2022DeRoyal Industries Inc
DeRoyal LUMBAR DISC PACK, REF 89-10590.02
Open, Classified
LRONone listed
Dec 15, 2022DeRoyal Industries Inc
DeRoyal CMC POSTERIOR SPINE PACK, REF 89-10570.01
Open, Classified
LRONone listed
Dec 15, 2022DeRoyal Industries Inc
DeRoyal CARDIAC LINEN PACK, REF 89-10543.02
Open, Classified
LRONone listed
Dec 15, 2022DeRoyal Industries Inc
DeRoyal CNRV SPINAL PACK, REF 89-10532.03
Open, Classified
LRONone listed
Dec 15, 2022DeRoyal Industries Inc
DeRoyal CNRV PERIPHERAL VAS PACK, REF 89-10530.03
Open, Classified
LRONone listed
Dec 15, 2022DeRoyal Industries Inc
DeRoyal PAIN TRAY, REF 89-10464.03
Open, Classified
LRONone listed
Dec 15, 2022DeRoyal Industries Inc
DeRoyal PAIN TRAY, REF 89-10464.02
Open, Classified
LRONone listed
Dec 15, 2022DeRoyal Industries Inc
DeRoyal HAND PACK, REF 89-10314.03
Open, Classified
LRONone listed
Dec 15, 2022DeRoyal Industries Inc
DeRoyal HAND PACK, REF 89-10314.02
Open, Classified
LRONone listed

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