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) |
|---|---|---|---|
| Nov 13, 2025 | Medline Industries, LP Convenience Kits:
DYNJ901048N ORTHO SPINE ST CLAIR
DYNJ909123F UROLOGY MINOR
DYNJ909132F SET UP
DYNJ909308D HIP PINNING Open, Classified |
LRO | K213481 |
| Oct 16, 2025 | American Contract Systems Inc. Medical convenience kits
Item number/ Product description
AKGN82E GENERAL
AMCB08Y CHEST BREAST PACK
ANBP10AC BASIC PACK - 205939
ANIR77AM INTERVENTIONAL RADIOLOGY PACK - 205953
CFLA39G LAPAROTOMY PA Open, Classified |
LRO | None listed |
| Oct 10, 2025 | Medline Industries, LP Medline Adult Anesthesia Set, REF DYNJ39985G Open, Classified |
LRO | K213481 |
| Sep 26, 2025 | Medline Industries, LP Sterile Medline Convenience Kits:
1) MAJOR PACK L-F, Model Number: DYNJ0382730O;
2) LB BASIC CUSTOM PACK, Model Number: DYNJ61038B Open, Classified |
LRO | K213481 |
| Sep 19, 2025 | MEDLINE INDUSTRIES, LP - Northfield Medline medical convenience kits labeled as:
1. NEWBORN RESUSCITATION KIT, Kit Number ACC010381C;
2. DRAWER 5 - POSITION 3, Kit Number ACC010532;
3. DRAWER #4C ADULT, Kit Number ACC010671;
4. DRA Open, Classified |
LRO | None listed |
| Sep 5, 2025 | AVID Medical, Inc. Halyard, CPT BASIC IR PACK. Model Number: 1646381.
Convenience kit. Open, Classified |
LRO | None listed |
| Sep 5, 2025 | AVID Medical, Inc. Halyard, ENT PACK. Model Number: JACK421-04.
Convenience kit. Open, Classified |
LRO | None listed |
| Aug 28, 2025 | American Contract Systems Inc AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as:
1) A-C SUPPLEMENT PACK - 205946, Model/Item Number ANCV67X;
2) KIDNEY PERFUSION PACK - 208439, Model/Item Number ANKP15AD;
Open, Classified |
LRO | None listed |
| Aug 27, 2025 | MEDLINE INDUSTRIES, LP - Northfield The Medline General Surgery Tray is customized to meet requirements of the hospitals and health care professionals utilizing them. The kit is provided sterile, single-use and includes a range of compo Open, Classified |
LRO | K213481 |
| Aug 4, 2025 | AVID Medical, Inc. ROBOTIC URO/GYN PACK. Medical convenience kit. Open, Classified |
LRO | None listed |
| Aug 4, 2025 | AVID Medical, Inc. ROBOTIC PROSTATECTOMY PACK. Medical convenience kit. Open, Classified |
LRO | None listed |
| Aug 4, 2025 | AVID Medical, Inc. PARTIAL NEPHRECTOMY PACK. Medical convenience kit. Open, Classified |
LRO | None listed |
| Aug 4, 2025 | AVID Medical, Inc. PARTIAL NEPHRECTOMY - ROBOTIC. Medical convenience kit. Open, Classified |
LRO | None listed |
| Aug 4, 2025 | AVID Medical, Inc. PACK GENERAL ROBOTIC. Medical convenience kit. Open, Classified |
LRO | None listed |
| Aug 4, 2025 | AVID Medical, Inc. MAJOR THORACOSCOPY BASIN. Medical convenience kit. Open, Classified |
LRO | None listed |
| Aug 4, 2025 | AVID Medical, Inc. LAPAROSCOPY PACK. Medical convenience kit. Open, Classified |
LRO | None listed |
| Aug 4, 2025 | AVID Medical, Inc. LAPAROSCOPIC PROSTATECTOMY. Medical convenience kit. Open, Classified |
LRO | None listed |
| Aug 4, 2025 | AVID Medical, Inc. LAPAROSCOPIC GYN. Medical convenience kit. Open, Classified |
LRO | None listed |
| Aug 4, 2025 | AVID Medical, Inc. LAP CHOLE PACK. Medical convenience kit. Open, Classified |
LRO | None listed |
| Aug 4, 2025 | AVID Medical, Inc. GS ENDOSCOPY PACK. Medical convenience kit. Open, Classified |
LRO | None listed |
| Aug 4, 2025 | AVID Medical, Inc. GENERAL LAPAROSCOPY TRAY. Medical convenience kit. Open, Classified |
LRO | None listed |
| Aug 4, 2025 | AVID Medical, Inc. GEN LAPAROSCOPY PACK. Medical convenience kit. Open, Classified |
LRO | None listed |
| Aug 4, 2025 | AVID Medical, Inc. DAVINCI UROLOGY. Medical convenience kit. Open, Classified |
LRO | None listed |
| Aug 4, 2025 | AVID Medical, Inc. DAVINCI TRUCUSTOM BUNDLE. Medical convenience kit. Open, Classified |
LRO | None listed |
| Aug 4, 2025 | AVID Medical, Inc. DA VINCI PACK URO/PROSTATE. Medical convenience kit. Open, Classified |
LRO | None listed |
| Aug 4, 2025 | AVID Medical, Inc. LAPAROSCOPIC TRAY. Medical convenience kit. Open, Classified |
LRO | None listed |
| Jul 21, 2025 | MEDLINE INDUSTRIES, LP - Northfield Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as:
LABOR TRIAGE KIT, REF DYKM1564 Open, Classified |
LRO | None listed |
| Jul 10, 2025 | Alcon Research LLC Brand Name: Alcon Laboratories, Inc.
Product Name: Custom Pak
Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List'
Software Version: N/A
Product Description: Alcon Custom Paks are c Open, Classified |
LRO | None listed |
| Jun 30, 2025 | MEDLINE INDUSTRIES, LP - Northfield Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as:
1) CC DRAWER 4 IV CIRCULATION, REF ACC010254B;
2) CC ADULT DRAWER 2, REF ACC010256;
3) PE Open, Classified |
LRO | None listed |
| Jun 20, 2025 | MEDLINE INDUSTRIES, LP - Northfield Medline UMBILICAL TRAY W/3.5&5FR CATH, REF UVT1250 Open, Classified |
LRO | None listed |
| May 31, 2025 | MEDLINE INDUSTRIES, LP - Northfield Medline Kits containing Codman Disposable Perforator 14 mm:
1. CRANI ADD A PACK, SKU DYNJ30926O
2. CRANIOTOMY, SKU CDS983611N
3. CRANIOTOMY CDS, SKU CDS983467J
4. CRANIOTOMY PACK, SKU DYNJ85807A, DYN Open, Classified |
LRO | K213481 |
| May 9, 2025 | AVID Medical, Inc. Halyard CHRIST SUTURE KIT. General Procedure Tray Convenience Kit Open, Classified |
LRO | None listed |
| May 1, 2025 | MEDLINE INDUSTRIES, LP - Northfield Medline procedure kits, labeled as:
1) STERILE PREP KIT, REF DYNDA1359A;
2) STRL EK SINGLE PACK, REF DYNDA1360B;
3) SHEATH REMOVAL TRAY, REF DYNDC1311C;
4) SENSITIVE SKIN WEEKLY VAD, REF DYNDC318 Open, Classified |
LRO | None listed |
| Apr 17, 2025 | MEDLINE INDUSTRIES, LP - Northfield Refer to RES Open, Classified |
LRO | None listed |
| Apr 10, 2025 | MEDLINE INDUSTRIES, LP - Northfield Medline medical convenience kits labeled as:
1) NEONATAL INTUBATION TRAY, REF ACC010371C;
2) NEWBORN RESUSCITATION KIT, REF ACC010381A;
3) NEWBORN RESUSCITATION KIT, REF ACC010381B;
4) NEWBORN RE Open, Classified |
LRO | K213481 |
| Apr 4, 2025 | MEDLINE INDUSTRIES, LP - Northfield Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows:
CPB ADJUNCT PACK, DR. C PACK, PK CUST CV A&B C CO, TOL DR R PACK, TOL DR. C PACK, TOL DR. M PACK. Open, Classified |
LRO | None listed |
| Mar 25, 2025 | MEDLINE INDUSTRIES, LP - Northfield Medline procedure kits labeled as:
1) A & A KNEE PACK-LF, Pack Number DYNJHS0136D;
2) ABD CLOSURE PACK, Pack Number DYNJ56987B;
3) ADULT PERC PACK-LF, Pack Number PHS170994005A;
4) BASIC PACK, Pa Open, Classified |
LRO | K962826 |
| Mar 14, 2025 | MEDLINE INDUSTRIES, LP - Northfield Proxima Drape labeled as HEAD AND NECK OSIS, WILLIS SHOULDER PACK, EXTREMITY PACK-LF, TOTAL HIP PACK-LF, SHOULDER W/POUCH-LF, VEIN PACK. Sterile surgical drape. Open, Classified |
LRO | K213481 |
| Mar 14, 2025 | MEDLINE INDUSTRIES, LP - Northfield Proxima Drape labeled as PACK,BASIC,SIRUS,V,5/CS; PACK,BASIC IV,SIRUS,5/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,SET UP, Open, Classified |
LRO | None listed |
| Mar 14, 2025 | American Contract Systems Inc GENERAL LAPAROSCOPIC PACK-LF
, Model No UTGL53S-06
UTGL53S-07
UTGL53S-08 Open, Classified |
LRO | None listed |
| Mar 14, 2025 | American Contract Systems Inc LACERATION TRAY
, Model No SGLA07A
SGLA07B-01
SGLA07B-02
SGLA07B Open, Classified |
LRO | None listed |
| Mar 14, 2025 | American Contract Systems Inc LACERATION TRAY
, Model No SGLA07A
SGLA07B-01
SGLA07B-02
SGLA07B Open, Classified |
LRO | None listed |
| Mar 14, 2025 | American Contract Systems Inc URO ROBOTIC PACK
, Model No LVUR44C
LVUR44C-03 Open, Classified |
LRO | None listed |
| Mar 14, 2025 | American Contract Systems Inc MAJOR DIEP, Model Nos.
CCMJ73G-01
CCMJ73H Open, Classified |
LRO | None listed |
| Mar 14, 2025 | American Contract Systems Inc DR DIULUS INJECTION PACK, Model Nos.
CCDU12C
CCDU12D
CCDU12D-01 Open, Classified |
LRO | None listed |
| Mar 6, 2025 | Alcon Research LLC Alcon Custom Pak with Non-Latex Symbol, Pak: 12771-18, 18050-10, 18252-17, 12698-09, 15632-10, 3141-45, 12630-07, 18925-05, 19265-05, 13894-16, 17550-08, 12236-18, 11854-15, 8043-29, 12466-17, 15599-1 Open, Classified |
LRO | K880961 |
| Feb 19, 2025 | MEDLINE INDUSTRIES, LP - Northfield Medline Convenience Kits for Various Procedures:
1) CLOVIS RESP/INTUB DRAWER 2, Model Number ACC010809;
2) RESP/INTUBATION DRAWER #2, Model Number ACC010813 Open, Classified |
LRO | K213481 |
| Feb 14, 2025 | MEDLINE INDUSTRIES, LP - Northfield Medline RR-LIVER TRNS ACCESSORY PEDS, DUNJ63397; medical procedure convenience kit Open, Classified |
LRO | None listed |
| Feb 10, 2025 | Cardinal Health 200, LLC Cardinal Health Presource Kits:
1) KIT,DIEP FLAP , Catalog Number:PB23DFCM3;
2) KIT,DIEP FLAP , Catalog Number:PB23DFCM4;
3) KIT,DIEP FLAP , Catalog Nu Open, Classified |
LRO | None listed |
| Jan 29, 2025 | MEDLINE INDUSTRIES, LP - Northfield Medline General Surgery Tray Kits:
1) ARTERIAL LINE INSERTION KIT, Item Number ART1185B;
2) ARTERIAL LINE BUNDLE, Item Number ART255;
3) ARTERIAL LINE TRAY, Item Number ART350;
4) ARTERIAL LINE BUND Open, Classified |
LRO | K213481 |
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