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)
Top companies in LRO
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2023 | MEDLINE 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 |
LRO | None listed |
| Jul 20, 2023 | MEDLINE 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 |
LRO | None listed |
| Jul 12, 2023 | MEDLINE 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 |
LRO | None listed |
| Jul 12, 2023 | MEDLINE 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 |
LRO | None listed |
| Jul 12, 2023 | MEDLINE INDUSTRIES, LP - Northfield MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: HYSTERO PACK, Model Number DYNJ61448A Open, Classified |
LRO | None listed |
| Jul 12, 2023 | MEDLINE INDUSTRIES, LP - Northfield MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: OISC HAND BEAR, Model Number DYNJ902348L Open, Classified |
LRO | None listed |
| Jul 12, 2023 | MEDLINE INDUSTRIES, LP - Northfield MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: TOTAL KNEE THEDA, Model Number DYNJ908683A Open, Classified |
LRO | None listed |
| Jul 12, 2023 | MEDLINE INDUSTRIES, LP - Northfield MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: EAR CDS, Model Number CDS980089O Open, Classified |
LRO | None listed |
| Jul 12, 2023 | MEDLINE INDUSTRIES, LP - Northfield MEDLINE NON-STERILE PVP SOLUTION, STERILE PACKAGING REF DYNDA2232A Open, Classified |
LRO | None listed |
| Jul 3, 2023 | DeRoyal 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 |
LRO | K842648 |
| Jun 7, 2023 | DeRoyal 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 |
LRO | K842648 |
| Apr 25, 2023 | ROi 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 |
LRO | None listed |
| Mar 28, 2023 | Alcon 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 |
LRO | K880961 |
| Feb 23, 2023 | MEDLINE 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 |
LRO | None listed |
| Feb 10, 2023 | MEDLINE 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 |
LRO | None listed |
| Feb 6, 2023 | MEDLINE 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 |
LRO | None listed |
| Jan 27, 2023 | MEDLINE INDUSTRIES, LP - Northfield Non-sterile procedural trays labeled as MAJOR/MINOR, 3 per case Open, Classified |
LRO | None listed |
| Jan 9, 2023 | DeRoyal Industries Inc DeRoyal ORGAN RECOVERY PACK PGYBK, a) REF 89-9004.09 and b) 89-9004.10 Terminated |
LRO | K842648 |
| Jan 5, 2023 | DeRoyal Industries Inc DeRoyal Tonsillectomy Tray, REF 89-10698.01 Terminated |
LRO | None listed |
| Dec 15, 2022 | DeRoyal Industries Inc DeRoyal CATARACT PACK, REF 89-10086.05 Open, Classified |
LRO | None listed |
| Dec 15, 2022 | DeRoyal Industries Inc DeRoyal CATARACT PACK, REF 89-10040.01 Open, Classified |
LRO | None listed |
| Dec 15, 2022 | DeRoyal Industries Inc DeRoyal CATARACT PACK, REF 89-9241.04 Open, Classified |
LRO | None listed |
| Dec 15, 2022 | DeRoyal Industries Inc DeRoyal CATARACT PACK, REF 89-9241.03 Open, Classified |
LRO | None listed |
| Dec 15, 2022 | DeRoyal Industries Inc DeRoyal CATARACT PACK, REF 89-8859.08 Open, Classified |
LRO | None listed |
| Dec 15, 2022 | DeRoyal Industries Inc DeRoyal CATARACT PACK, REF 89-8650.10 Open, Classified |
LRO | None listed |
| Dec 15, 2022 | DeRoyal Industries Inc GEO-MED CATARACT PACK, REF 89-5790.08 Open, Classified |
LRO | None listed |
| Dec 15, 2022 | DeRoyal Industries Inc DeRoyal TRACECART POSTEROR LAMI MICRODISC TRACECART, REF 53-1960.02 Open, Classified |
LRO | None listed |
| Dec 15, 2022 | DeRoyal Industries Inc DeRoyal TRACECART POSTEROR LUMBAR FUSION TRACECART, REF 53-1961.02 Open, Classified |
LRO | None listed |
| Dec 15, 2022 | DeRoyal Industries Inc DeRoyal TRACECART SHOULDER ARTHROSCOPY TRACECART, REF 53-1962.02 Open, Classified |
LRO | None listed |
| Dec 15, 2022 | DeRoyal Industries Inc DeRoyal BIOPSY PACKPACK, REF 89-9756.05 Open, Classified |
LRO | None listed |
| Dec 15, 2022 | DeRoyal Industries Inc DeRoyal TOTAL KNEE PACK A & B PACK, REF 89-6799.02 Open, Classified |
LRO | None listed |
| Dec 15, 2022 | DeRoyal Industries Inc DeRoyal PACEMAKER ICD PACK, REF 89-10902.01 Open, Classified |
LRO | None listed |
| Dec 15, 2022 | DeRoyal Industries Inc DeRoyal NEURO SPINE BACK PACK PGYBK, REF 89-10853.01 Open, Classified |
LRO | None listed |
| Dec 15, 2022 | DeRoyal Industries Inc DeRoyal SHOULDER ARTHOSCOPY PACK, REF 89-10820.02 Open, Classified |
LRO | None listed |
| Dec 15, 2022 | DeRoyal Industries Inc GEO-MED LOCAL ANESTHESIA PACK, REF 89-10800.01 Open, Classified |
LRO | None listed |
| Dec 15, 2022 | DeRoyal Industries Inc DeRoyal LAMI/CRANI PACK, REF 89-10787.01 Open, Classified |
LRO | None listed |
| Dec 15, 2022 | DeRoyal Industries Inc DeRoyal NEURO PACK, REF 89-10682.02 Open, Classified |
LRO | None listed |
| Dec 15, 2022 | DeRoyal Industries Inc DeRoyal GU PACK, REF 89-10665.03 Open, Classified |
LRO | None listed |
| Dec 15, 2022 | DeRoyal Industries Inc DeRoyal GU PACK, REF 89-10665.02 Open, Classified |
LRO | None listed |
| Dec 15, 2022 | DeRoyal Industries Inc DeRoyal ANTERIOR APPROACH TOTAL HIP A&B PGYBK, REF 89-10612.01 Open, Classified |
LRO | None listed |
| Dec 15, 2022 | DeRoyal Industries Inc DeRoyal LUMBAR DISC PACK, REF 89-10605.02 Open, Classified |
LRO | None listed |
| Dec 15, 2022 | DeRoyal Industries Inc DeRoyal LUMBAR DISC PACK, REF 89-10590.02 Open, Classified |
LRO | None listed |
| Dec 15, 2022 | DeRoyal Industries Inc DeRoyal CMC POSTERIOR SPINE PACK, REF 89-10570.01 Open, Classified |
LRO | None listed |
| Dec 15, 2022 | DeRoyal Industries Inc DeRoyal CARDIAC LINEN PACK, REF 89-10543.02 Open, Classified |
LRO | None listed |
| Dec 15, 2022 | DeRoyal Industries Inc DeRoyal CNRV SPINAL PACK, REF 89-10532.03 Open, Classified |
LRO | None listed |
| Dec 15, 2022 | DeRoyal Industries Inc DeRoyal CNRV PERIPHERAL VAS PACK, REF 89-10530.03 Open, Classified |
LRO | None listed |
| Dec 15, 2022 | DeRoyal Industries Inc DeRoyal PAIN TRAY, REF 89-10464.03 Open, Classified |
LRO | None listed |
| Dec 15, 2022 | DeRoyal Industries Inc DeRoyal PAIN TRAY, REF 89-10464.02 Open, Classified |
LRO | None listed |
| Dec 15, 2022 | DeRoyal Industries Inc DeRoyal HAND PACK, REF 89-10314.03 Open, Classified |
LRO | None listed |
| Dec 15, 2022 | DeRoyal Industries Inc DeRoyal HAND PACK, REF 89-10314.02 Open, Classified |
LRO | None listed |
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