Panels › General, Plastic Surgery › Product code LRO · Class 2
General Surgery Tray
Regulation 878.4370
0510(k)s in 12 months (110 all time)
103recalls in 12 months (1,084 all time)
141recalls that name a 510(k)
Top companies in LRO
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 1, 2022 | MEDLINE INDUSTRIES, LP - Northfield MEDLINE LITHOTOMY, REF DYNJ50099C. Convenience kit used in medical/surgical procedures. Open, Classified |
LRO | None listed |
| Nov 1, 2022 | MEDLINE INDUSTRIES, LP - Northfield BAUSCH + LOMB EYE PACK, REF LYN003EYSPA. Convenience kit used in surgical procedures. Open, Classified |
LRO | None listed |
| Oct 21, 2022 | MEDLINE INDUSTRIES, LP - Northfield MEDLINE PRE-OP CHG BATHING KIT Reorder #: P164756 Open, Classified |
LRO | None listed |
| Oct 21, 2022 | MEDLINE INDUSTRIES, LP - Northfield MEDLINE 24 BLOOD CLUTURE KIT, Reorder #: DYNDH1632 Open, Classified |
LRO | None listed |
| Oct 21, 2022 | MEDLINE INDUSTRIES, LP - Northfield MEDLINE BLOOD CLUTURE KIT, Reorder #: DYNDH1592 Open, Classified |
LRO | None listed |
| Oct 21, 2022 | MEDLINE INDUSTRIES, LP - Northfield MEDLINE PHERIPHERAL BLOOD CULTURE DRAW, Reorder #: DYNDH1561 Open, Classified |
LRO | None listed |
| Oct 21, 2022 | MEDLINE INDUSTRIES, LP - Northfield MEDLINE ADLT BLOOD CLUTURE COLLECT KIT, Reorder #: DYNDH1245 Open, Classified |
LRO | None listed |
| Oct 20, 2022 | MEDLINE INDUSTRIES, LP - Northfield CENTURION SnagFree Chest Tube insertion Tray, Reorder CHT545 Terminated |
LRO | None listed |
| Aug 12, 2022 | DeRoyal Industries Inc DeRoyal Sterile Custom Kits containing ICU Medical MicroClave Clear Connectors Terminated |
LRO | K842648 |
| Jun 16, 2022 | American Contract Systems, Inc. Various convenience packs Open, Classified |
LRO | None listed |
| Jun 9, 2022 | Alcon Research, LLC Alcon Custom Pak Surgical Procedure Pack:
16998-11 2519351H SALAHUDDIN 2.4 PACK FRESNO SURGICAL HOSP
18392-03 14HDFF CATARACT SWAGEL WOOTTON EYE INSTITUTE
18527-03 14JM57 DOSS CATARACT ALLIANCE EYE Open, Classified |
LRO | K880961 |
| Jun 6, 2022 | MEDLINE INDUSTRIES, LP - SPT Medline Convenience kits labeled as: a. MAJOR VASCULAR CDS, b. POST OP KIT, c. KIT NEURO FUS LUM POST SANSUR, d. KIT NEURO FUS LUM POST SANSUR , e. PRE-OP ACCESSORY KIT CHOICE, f. DEEP BRAIN STIMULAT Open, Classified |
LRO | None listed |
| May 3, 2022 | ROi CPS LLC regard GS0098C - RESUSABLE RT BRONCH, Item Number: 830086003 Terminated |
LRO | None listed |
| Mar 3, 2022 | DeRoyal Industries Inc DeRoyal DEXMED ACCESS CENTER TRAY, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl alcohol) swab, for preparation of the patient skin prior to surgery or injection. Terminated |
LRO | K842648 |
| Mar 3, 2022 | DeRoyal Industries Inc DeRoyal Ultra/Mammo Tray, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl alcohol) swab, for preparation of the patient skin prior to surgery or injection. Terminated |
LRO | K842648 |
| Oct 27, 2021 | Medline Industries Inc Major Vascular CDS Convenience Kit Terminated |
LRO | None listed |
| Oct 27, 2021 | Medline Industries Inc EVLP Convenience Pack/Kit Terminated |
LRO | None listed |
| Sep 29, 2021 | Deroyal Industries, Inc. Lafollette DeRoyal Procedure Packs containing Smiths Medical NORMOFLO Irrigation Warming Set Terminated |
LRO | K842648 |
| Aug 10, 2021 | ROi CPS LLC REGARD Core Biopsy Tray Terminated |
LRO | None listed |
| Jun 10, 2021 | DeRoyal Industries Inc DeRoyal Angio Cath Removal Tray, REF 89-9936.02 Terminated |
LRO | None listed |
| Jun 10, 2021 | DeRoyal Industries Inc DeRoyal Heart Cath Procedure Pack, REF 89-6556.08 Terminated |
LRO | None listed |
| Jun 10, 2021 | DeRoyal Industries Inc DeRoyal Pacemaker Tray Pgybk, REF 89-6360.06 Terminated |
LRO | K842648 |
| Jun 4, 2021 | Avid Medical, Inc. DIALYSIS ACCESS Medical convenience kit, Avid Medical Part Number: VMED004-03. Terminated |
LRO | None listed |
| Jun 4, 2021 | Avid Medical, Inc. FISTULA ON-OFF KIT. Medical convenience kit, Avid Medical Part Number: MMTN020. Terminated |
LRO | None listed |
| Jun 4, 2021 | Avid Medical, Inc. ADULT CHEST TUBE TRAY. Medical convenience kit, Avid Medical Part Number: LAKC001-04 Terminated |
LRO | None listed |
| May 11, 2021 | Medical Action Industries, Inc. 306 Medical Action INDUSTRIES INC., Minor Procedure Tray, REF 61214 Terminated |
LRO | None listed |
| Apr 30, 2021 | Medline Industries Inc Medline Tissue Recovery Instrument Set, Reorder #DYNJ64347A, packaged 3/case, Sterile, Rx.
Convenience kit used to recover tissue, which can be used for medical research, education, or transplantati Open, Classified |
LRO | None listed |
| Apr 1, 2021 | Alcon Research, LLC Alcon Custom Ophthalmic Surgical Procedure Packs Terminated |
LRO | K880961 |
| Jan 25, 2021 | DeRoyal Industries Inc Heart Pack, REF numbers:
a) 89-9194.07
b) 89-9194.09
c) 89-9194-10
d) 89-9194-11
Custom surgical procedure packs including sternum saw blades. Terminated |
LRO | K842648 |
| Jan 25, 2021 | DeRoyal Industries Inc Open Heart Pack, REF numbers:
a) 89-7483.07
b) 89-7483.08
c) 89-7483.09
d) 89-7483.10
Custom surgical procedure packs including sternum saw blades. Terminated |
LRO | K842648 |
| Jan 25, 2021 | DeRoyal Industries Inc CV Basin Set Pack, REF numbers:
a) 89-7935.11
b) 89-7935.12
c) 89-7935.13
d) 89-7935.14
e) 89-7935.15
f) 89-7935.16
Custom surgical procedure packs including sternum saw blades. Terminated |
LRO | K842648 |
| Nov 13, 2020 | Medline Industries Inc Greffe Aorte-LF (product info is in French); Model DYNJ31877F - Product Usage: This is a type of convenience kit used in various surgeries including cardiac, abdominal, and neck surgeries. Terminated |
LRO | None listed |
| Aug 24, 2020 | Alcon Research, LLC Alcon Custom-Pak Surgical Procedure Packs containing Cardinal Health" PROTEXIS" Latex Micro Surgical Gloves - Product Usage: used by ophthalmic surgeons in a variety of ophthalmic surgeries. Terminated |
LRO | K880961 |
| Jul 28, 2020 | Wright Medical Technology, Inc. Screw Removal Case Assembly, Part Number 1985BASE - Product Usage: The Wright Medical hardware removal kit is designed to facilitate removal of both plates and screws used in foot and ankle procedures Terminated |
LRO | None listed |
| Jul 28, 2020 | Wright Medical Technology, Inc. Hardware removal kit, Part Number 1985KIT1 - Product Usage: The Wright Medical hardware removal kit is designed to facilitate removal of both plates and screws used in foot and ankle procedures. Along Terminated |
LRO | None listed |
| Apr 13, 2020 | American Contract Systems Sterile Custom Packs to be used in surgical procedures. Terminated |
LRO | None listed |
| Apr 13, 2020 | American Contract Systems Sterile Custom Packs to be used in surgical procedures. Terminated |
LRO | None listed |
| Mar 9, 2020 | Medline Industries Inc Custom convenience kits containing Medline brand Sterile Pre-Saturated Povidone Iodine Sponge Products, labeled as follows:
Part Description Part Number
ABDOMINAL HYSTERECTOMY DYNJ906478
ABDOMINAL HYS Terminated |
LRO | None listed |
| Feb 19, 2020 | Deroyal Industries, Inc. Lafollette DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following:
ASC Ocular Plastics Pack 89-6498.13 Terminated |
LRO | K842648 |
| Feb 19, 2020 | Deroyal Industries, Inc. Lafollette DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following:
Kwik Kit 89-6389.06 Terminated |
LRO | K842648 |
| Feb 19, 2020 | Deroyal Industries, Inc. Lafollette DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following:
Ophthalmology CSTM PCK 89-6387.08 Terminated |
LRO | K842648 |
| Feb 19, 2020 | Deroyal Industries, Inc. Lafollette DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following:
ASC Thyroid Pack 89-6302.14 Terminated |
LRO | K842648 |
| Feb 19, 2020 | Deroyal Industries, Inc. Lafollette DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following:
ASC Laparoscopy Pack 89-6138.13 Terminated |
LRO | K842648 |
| Feb 19, 2020 | Deroyal Industries, Inc. Lafollette DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following:
Cystoscopy Pack 89-6071.15 Terminated |
LRO | K842648 |
| Feb 19, 2020 | Deroyal Industries, Inc. Lafollette DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following:
ASC General Pack 89-6015.16 Terminated |
LRO | K842648 |
| Feb 19, 2020 | Deroyal Industries, Inc. Lafollette DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following:
Shoulder Pack 89-4751.08 Terminated |
LRO | K842648 |
| Feb 19, 2020 | Deroyal Industries, Inc. Lafollette DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following:
Chronic Ear Pack 89-4393.17 Terminated |
LRO | K842648 |
| Feb 19, 2020 | Deroyal Industries, Inc. Lafollette DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following:
Outpatient Major 89-3865.12; Terminated |
LRO | K842648 |
| Feb 18, 2020 | Avid Medical, Inc. Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multiple item and lot numbers. Terminated |
LRO | None listed |
| Feb 10, 2020 | Medline Industries Inc Medline Sterile 3mL Syringes with 21GA x 1 Inch Needle 80 each REF DYND3ML21G1A lot 18JBH655 (01) 1088438982153. Terminated |
LRO | None listed |
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