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

Company510(k)sRecalls
Customed, Inc.6232
Deroyal Industries, Inc.1192
Resource Optimization & Innovation Llc0139
AVID Medical, Inc.0122
Medline Industries, Inc.584
MEDLINE INDUSTRIES, LP - Northfield083
Stradis Healthcare, LLC.051
Custom Healthcare Systems, Inc.030
American Contract Systems020
Cardinal Health018
DateFirm and productCodeLinked 510(k)
Oct 22, 2026AVID Medical, Inc.
Halyard ANTERIOR HIP PACK. Model/Catalog Number: SOAH30.
Open, Classified		 LRONone listed
Oct 22, 2026AVID Medical, Inc.
Halyard ANTERIOR HIP PACK. Model/Catalog Number: SOAH31.
Open, Classified		 LRONone listed
Oct 15, 2026Medline Industries, LP
Convenience Kits containing CONMED AirSeal Access Ports GENERAL DAVINCI DYNJG901004C LAP CHOLE DYNJ88071 ROBOTIC PACK DYNJ50474F
Open, Classified		 LRONone listed
Oct 15, 2026Medline Industries, LP
Convenience Kits containing CONMED AirSeal Access Ports HERNANDEZ DAVINCI ACC BUNDLE M DYNJ911258 KIT ROBOTICS UROLOGY PROSTATE DYKMBNDL116I ROBOTIC CHEST DYNJ910997 DYNJ910997A RR-DAVINCI
Open, Classified		 LRONone listed
Oct 15, 2026Medline Industries, LP
Medline surgical convenience kits labeled as: 1) OPEN HEART PACK A & B, Medline Product number/SKU DYNJ04584L; 2) OPEN HEART ACCESSORY PACK, Medline Product number/SKU DYNJT5715A; 3) CABG ACCESSORY PA
Open, Classified		 LRONone listed
Oct 7, 2026AVID Medical, Inc.
MAJOR PACK; Model/Item Number (Kit): NIHB0018-11;
Open, Classified		 LRONone listed
Oct 7, 2026AVID Medical, Inc.
UROLOGY MAJOR; Model/Item Number (Kit): WRNM058-10;
Open, Classified		 LRONone listed
Oct 7, 2026AVID Medical, Inc.
HEART PREP TRAY; Model/Item Number (Kit): MECV97W;
Open, Classified		 LRONone listed
Oct 7, 2026AVID Medical, Inc.
PLASTICS TRAY; Model/Item Number (Kit): EURO053;
Open, Classified		 LRONone listed
Oct 7, 2026AVID Medical, Inc.
LAPAROSCOPIC PROSTATECTOMY; Model/Item Number (Kit): NIHB0036-07;
Open, Classified		 LRONone listed
Oct 7, 2026AVID Medical, Inc.
GYN LAPAROSCOPY/LAPAROTOMY; Model/Item Number (Kit): 1. WRNM002-15, 2. FBCH108-03;
Open, Classified		 LRONone listed
Oct 7, 2026AVID Medical, Inc.
DAVINCI TRUCUSTOM BUNDLE; Model/Item Number (Kit): 1. SAMM064-27, 2. SAMM064-28;
Open, Classified		 LRONone listed
Sep 25, 2026Cardinal Health 200, LLC
Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT, LAP CHOLE , Catalog Number: PGCGLCBAC; 2) KIT, LAP CHOLE , Catalog Number: PGCGLCBAD; 3) KI
Open, Classified		 LRONone listed
Sep 24, 2026Medline Industries, LP
Medline Convenience Kits: 1) MFC CRANIOTOMY PACK, Catalog Number: DYNJT8784; 2) SLUH CRANIOTOMY PACK-LF, Catalog Number: DYNJ0369348Q; 3) SLUH CRANIOTOMY PACK-LF, Catalog Number: DYNJ0369348R; 4) S
Open, Classified		 LROK213481
Sep 23, 2026AVID Medical, Inc.
Halyard IV START KIT NON-STERILE; 48 kits per case. Containing BD ChloraPrep Clear - 1 mL Applicator. Kit Model Number: KRIV26-01
Open, Classified		 LRONone listed
Sep 23, 2026AVID Medical, Inc.
Halyard IV START KIT NON-STERILE; 48 kits per case. Containing BD ChloraPrep Clear - 1 mL Applicator. Kit Model Number: KRIV26-02
Open, Classified		 LRONone listed
Sep 23, 2026AVID Medical, Inc.
Halyard IV START KIT NON-STERILE; 48 kits per case. Containing BD ChloraPrep Clear - 1 mL Applicator. Kit Model Number: KRIV26-02.
Open, Classified		 LRONone listed
Sep 18, 2026Medline Industries, LP
Medline convenience kits containing Healthmark Instrument Channel Brushes. SINUS PACK DYNJ48258D and Sinus Pack DYNJ48258F.
Open, Classified		 LROK213481
Sep 16, 2026AVID Medical, Inc.
Haylard BASIC BIOPSY TRAY; Model/Item Number (Kit): PM415;
Open, Classified		 LRONone listed
Sep 16, 2026Medline Industries, LP
Convenience kits MYRINGOTOMY PACK-LF DYNJ59097A
Open, Classified		 LROK213481
Sep 14, 2026AVID Medical, Inc.
Halyard IV START KIT NON-STERILE REF: KRIV26-02
Open, Classified		 LRONone listed
Sep 14, 2026Medline Industries, LP
Medline Convenience Kits: 1) ACC010308A, Catalog Number: ACC010308A; 2) ACC010374A, Catalog Number: ACC010374A; 3) ACC010679, Catalog Number: ACC010679; 4) ACC010726A, Catalog Number: ACC010726A;
Open, Classified		 LRONone listed
Sep 11, 2026Medline Industries, LP
Medline Convenience Kit: OPEN HEART A PACK, Product Number DYNJ43008N
Open, Classified		 LROK213481
Sep 4, 2026AVID Medical, Inc.
Halyard IV Start Kit Non-Sterile REF: KRIV26-02
Open, Classified		 LRONone listed
Sep 3, 2026Cardinal Health 200, LLC
Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, GYN ROBOTIC GSAM , Catalog Number: PBCCGRSGD; 2) KIT, GYN ROBOT ACCESSORY , Catalog Number:
Open, Classified		 LRONone listed
Aug 31, 2026Medline Industries, LP
Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators BLOOD CULTURE PINK PERIPHERAL DYNDV1875 BOTTOM DRAWER ACC010972 DRAWER #4 ACC010479A DRAWER 2 ACC010690
Open, Classified		 LROK213481
Aug 31, 2026Medline Industries, LP
Medline Convenience Kits: 1) IV START KIT, Catalog Number: DYNDV2520; 2) PERIPHERAL LAB BLOOD CULTURE KIT, Catalog Number: DYNDH1983A; 3) PEDI EMERGENCY TRAY-PURPLE, Catalog Number: ACC010157C; 4)
Open, Classified		 LROK213481
Aug 28, 2026AVID Medical, Inc.
Halyard medical convenience kits labeled as: 1) ENT, Model/Item Number (kit) ACEN89-01; 2) ENT, Model/Item Number (kit) ACEN89-02; 3) BACK PACK, Model/Item Number (kit) ALBK51-01; 4) DR DERIAN SP
Open, Classified		 LRONone listed
Aug 26, 2026Medline Industries, LP
Medline convenience kits labeled as: 1) MAJOR GYN PACK, Medline Kit SKU DYNJG001030C; 2) GYN LITHOTOMY PACK, Medline Kit SKU DYNJT8166; 3) OPEN HEART PACK, Medline Kit SKU DYNJ47638B; 4) EAST DAV
Open, Classified		 LROK213481
Aug 21, 2026AVID Medical, Inc.
Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03
Open, Classified		 LRONone listed
Aug 21, 2026AVID Medical, Inc.
Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03
Open, Classified		 LRONone listed
Aug 21, 2026AVID Medical, Inc.
Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03
Open, Classified		 LRONone listed
Aug 21, 2026AVID Medical, Inc.
Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03
Open, Classified		 LRONone listed
Aug 21, 2026AVID Medical, Inc.
Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03
Open, Classified		 LRONone listed
Aug 21, 2026AVID Medical, Inc.
Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03
Open, Classified		 LRONone listed
Aug 21, 2026AVID Medical, Inc.
Brand Name: Halyard Product Name: DAVINCI TRUCUSTOM BUNDLE containing TRAY FOLEY 16FR W/STATLOCK Model/Catalog Number: SAMM064-27
Open, Classified		 LRONone listed
Aug 21, 2026Medline Industries, LP
Medline medical convenience kits, labeled as: 1) CRANIOTOMY PACK, Medline Kit SKU DYNJT6545; 2) ORTHO SPINE PACK, Medline Kit SKU DYNJ88056A; 3) ENT SINUS PACK, Medline Kit SKU DYNJ89001; 4) THYR
Open, Classified		 LROK213481
Aug 13, 2026Cardinal Health 200, LLC
Cardinal Health Presource Kits: 1) FAT GRAFT ADD KIT , Catalog Number: 21-4720B; 2) TRAY FAT GRAFT ADD , Catalog Number: 21-4720C; 3) KIT,BOSC MICROLARYNGOSCOPY , Catalog N
Open, Classified		 LRONone listed
Jul 27, 2026Windstone Medical Packaging, Inc.
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Loop Recorder Pack 2 -RX, Part Number AMS10164; 2) NY Tray - RX, Part Number AMS10276A; 3) NYC Tray - RX, Part Number AMS10281
Open, Classified		 LRONone listed
Jul 24, 2026Windstone Medical Packaging, Inc.
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) ENT Pack, Part Number AMS10411B; 2) ENT Pack, Part Number AMS10411C; 3) Rhinoplasty Pack, Part Number AMS11963A; 4) Spine Pac
Open, Classified		 LRONone listed
Jul 23, 2026Medline Industries, LP
Medline medical convenience kits labeled as: 1) SHOULDER PACK, Medline Kit SKU DYNJ39590O; 2) SHOULDER PACK, Medline Kit SKU DYNJ88566; 3) MAJOR ORTHO KIT, Medline Kit SKU DYNJ911535.
Open, Classified		 LRONone listed
Jul 23, 2026Medline Industries, LP
Medline convenience kits containing Bard Silastic Foley Catheters (French sizes 16, 18, 20) 5cc balloons. UROLOGY ROBOTIC PROCEDURE PACK DYNJ0945779U
Open, Classified		 LRONone listed
Jul 23, 2026Medline Industries, LP
Medline convenience kits containing Bard Silastic Foley Catheters (French sizes 16, 18, 20) 5cc balloons. KIT ROBOTICS UROLOGY PROSTATE DYKMBNDL116I
Open, Classified		 LRONone listed
Jul 23, 2026Medline Industries, LP
MEDLINE medical procedure convenience kit labeled as: HIP CDS-LF, Medline kit SKU CDS984556N
Open, Classified		 LROK213481
Jul 22, 2026Medline Industries, LP
MEDLINE ANTERIOR HIP, Medline Kit SKU DYNJ909640G
Open, Classified		 LROK213481
Jul 15, 2026Medline Industries, LP
Medline Kits containing Zimmer Biomet mixing bowls and spatulas TOTAL KNEE PACK DYNJT6267
Open, Classified		 LROK213481
Jul 8, 2026Medline Industries, LP
Medline Convenience Kits: 1) OPEN HEART PEDS PACK, Model Number: DYNJ88569; 2) OPEN HEART PEDS PACK, Model Number: DYNJ88569A; 3) OPEN HEART PEDS PACK, Model Number: DYNJ88569B; 4) OPEN HEART PEDS
Open, Classified		 LROK213481
Jul 1, 2026Windstone Medical Packaging, Inc.
A M S, ALIGNED MEDICAL SOLUTIONS, Dr. Lewin Pack, Pack Number AMS7200D, surgical convenience kit
Open, Classified		 LRONone listed
Jul 1, 2026Windstone Medical Packaging, Inc.
A M S, ALIGNED MEDICAL SOLUTIONS, Preop Kit-NS, Pack Number AMS18227, surgical convenience kit
Open, Classified		 LRONone listed
Jul 1, 2026Windstone Medical Packaging, Inc.
A M S, ALIGNED MEDICAL SOLUTIONS, DSAEK Pack-RX, Pack Number AMS12394B, surgical convenience kit
Open, Classified		 LRONone listed

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