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)
103recalls in 12 months (1,084 all time)
141recalls that name a 510(k)
Get daily alerts for LROSample briefCSV

Top companies in LRO

DateFirm and productCodeLinked 510(k)
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
Oct 21, 2022MEDLINE INDUSTRIES, LP - Northfield
MEDLINE PRE-OP CHG BATHING KIT Reorder #: P164756
Open, Classified
LRONone listed
Oct 21, 2022MEDLINE INDUSTRIES, LP - Northfield
MEDLINE 24 BLOOD CLUTURE KIT, Reorder #: DYNDH1632
Open, Classified
LRONone listed
Oct 21, 2022MEDLINE INDUSTRIES, LP - Northfield
MEDLINE BLOOD CLUTURE KIT, Reorder #: DYNDH1592
Open, Classified
LRONone listed
Oct 21, 2022MEDLINE INDUSTRIES, LP - Northfield
MEDLINE PHERIPHERAL BLOOD CULTURE DRAW, Reorder #: DYNDH1561
Open, Classified
LRONone listed
Oct 21, 2022MEDLINE INDUSTRIES, LP - Northfield
MEDLINE ADLT BLOOD CLUTURE COLLECT KIT, Reorder #: DYNDH1245
Open, Classified
LRONone listed
Oct 20, 2022MEDLINE INDUSTRIES, LP - Northfield
CENTURION SnagFree Chest Tube insertion Tray, Reorder CHT545
Terminated
LRONone listed
Aug 12, 2022DeRoyal Industries Inc
DeRoyal Sterile Custom Kits containing ICU Medical MicroClave Clear Connectors
Terminated
LROK842648
Jun 16, 2022American Contract Systems, Inc.
Various convenience packs
Open, Classified
LRONone listed
Jun 9, 2022Alcon 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
LROK880961
Jun 6, 2022MEDLINE 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
LRONone listed
May 3, 2022ROi CPS LLC
regard GS0098C - RESUSABLE RT BRONCH, Item Number: 830086003
Terminated
LRONone listed
Mar 3, 2022DeRoyal 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
LROK842648
Mar 3, 2022DeRoyal 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
LROK842648
Oct 27, 2021Medline Industries Inc
Major Vascular CDS Convenience Kit
Terminated
LRONone listed
Oct 27, 2021Medline Industries Inc
EVLP Convenience Pack/Kit
Terminated
LRONone listed
Sep 29, 2021Deroyal Industries, Inc. Lafollette
DeRoyal Procedure Packs containing Smiths Medical NORMOFLO Irrigation Warming Set
Terminated
LROK842648
Aug 10, 2021ROi CPS LLC
REGARD Core Biopsy Tray
Terminated
LRONone listed
Jun 10, 2021DeRoyal Industries Inc
DeRoyal Angio Cath Removal Tray, REF 89-9936.02
Terminated
LRONone listed
Jun 10, 2021DeRoyal Industries Inc
DeRoyal Heart Cath Procedure Pack, REF 89-6556.08
Terminated
LRONone listed
Jun 10, 2021DeRoyal Industries Inc
DeRoyal Pacemaker Tray Pgybk, REF 89-6360.06
Terminated
LROK842648
Jun 4, 2021Avid Medical, Inc.
DIALYSIS ACCESS Medical convenience kit, Avid Medical Part Number: VMED004-03.
Terminated
LRONone listed
Jun 4, 2021Avid Medical, Inc.
FISTULA ON-OFF KIT. Medical convenience kit, Avid Medical Part Number: MMTN020.
Terminated
LRONone listed
Jun 4, 2021Avid Medical, Inc.
ADULT CHEST TUBE TRAY. Medical convenience kit, Avid Medical Part Number: LAKC001-04
Terminated
LRONone listed
May 11, 2021Medical Action Industries, Inc. 306
Medical Action INDUSTRIES INC., Minor Procedure Tray, REF 61214
Terminated
LRONone listed
Apr 30, 2021Medline 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
LRONone listed
Apr 1, 2021Alcon Research, LLC
Alcon Custom Ophthalmic Surgical Procedure Packs
Terminated
LROK880961
Jan 25, 2021DeRoyal 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
LROK842648
Jan 25, 2021DeRoyal 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
LROK842648
Jan 25, 2021DeRoyal 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
LROK842648
Nov 13, 2020Medline 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
LRONone listed
Aug 24, 2020Alcon 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
LROK880961
Jul 28, 2020Wright 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
LRONone listed
Jul 28, 2020Wright 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
LRONone listed
Apr 13, 2020American Contract Systems
Sterile Custom Packs to be used in surgical procedures.
Terminated
LRONone listed
Apr 13, 2020American Contract Systems
Sterile Custom Packs to be used in surgical procedures.
Terminated
LRONone listed
Mar 9, 2020Medline 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
LRONone listed
Feb 19, 2020Deroyal Industries, Inc. Lafollette
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: ASC Ocular Plastics Pack 89-6498.13
Terminated
LROK842648
Feb 19, 2020Deroyal Industries, Inc. Lafollette
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Kwik Kit 89-6389.06
Terminated
LROK842648
Feb 19, 2020Deroyal Industries, Inc. Lafollette
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Ophthalmology CSTM PCK 89-6387.08
Terminated
LROK842648
Feb 19, 2020Deroyal Industries, Inc. Lafollette
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: ASC Thyroid Pack 89-6302.14
Terminated
LROK842648
Feb 19, 2020Deroyal Industries, Inc. Lafollette
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: ASC Laparoscopy Pack 89-6138.13
Terminated
LROK842648
Feb 19, 2020Deroyal Industries, Inc. Lafollette
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Cystoscopy Pack 89-6071.15
Terminated
LROK842648
Feb 19, 2020Deroyal Industries, Inc. Lafollette
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: ASC General Pack 89-6015.16
Terminated
LROK842648
Feb 19, 2020Deroyal Industries, Inc. Lafollette
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Shoulder Pack 89-4751.08
Terminated
LROK842648
Feb 19, 2020Deroyal Industries, Inc. Lafollette
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Chronic Ear Pack 89-4393.17
Terminated
LROK842648
Feb 19, 2020Deroyal Industries, Inc. Lafollette
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Outpatient Major 89-3865.12;
Terminated
LROK842648
Feb 18, 2020Avid 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
LRONone listed
Feb 10, 2020Medline Industries Inc
Medline Sterile 3mL Syringes with 21GA x 1 Inch Needle 80 each REF DYND3ML21G1A lot 18JBH655 (01) 1088438982153.
Terminated
LRONone listed

Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.