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) |
|---|---|---|---|
| Jun 29, 2026 | Medline Industries, LP Medline Convenience Kits:
1) PI CVC KIT 3L 7 FR 16 CM, Model Number: ECVC8520;
2) NO CATH CENTRAL LINE KIT, Model Number: CVI4880B;
3) 20G x 6" ARTERIAL CATHETER KIT, Model Number: ART356;
4) MULTI Open, Classified |
LRO | K213481 |
| Jun 26, 2026 | Medline Industries, LP Medline Convenience kits containing recalled Swan-Ganz Catheters
OPEN HEART
DYNJ909090B
OPEN HEART CDS QVH
CDS982523M Open, Classified |
LRO | K213481 |
| Jun 26, 2026 | Medline Industries, LP Medline Convenience kits containing recalled Swan-Ganz Catheters
KIT GERMANTOWN CABG
DYNJ905855
KIT UNIVERSITY CABG PACK
DYNJ905857
OH MED RN CDS
DYNJ905936B Open, Classified |
LRO | None listed |
| Jun 25, 2026 | Medline Industries, LP Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes.
CATARACT FULL BODY
DYNJ85743
MAJOR VASCULAR PACK
DYNJ81610C
MINIMALLY INVASIVE PACK-LF
DYNJ0843063L
PEDIATR Open, Classified |
LRO | K213481 |
| Jun 25, 2026 | Medline Industries, LP Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes.
AAA
DYNJ905651B
ARTERIOGRAM TRAY
00-402001S
AV SHUNT PACK-LF
DYNJ0842516F
BASIC IR PACK-LF
PHS463660F
C Open, Classified |
LRO | None listed |
| Jun 24, 2026 | Medline Industries, LP Medline Convenience Kits:
1) DRAWER 6A ADULT CENTRAL LINE, Model Number: ACC010890;
2) OPEN HEART A OVERHEAD, Model Number: DYNJ910066;
3) OPEN HEART, Model Number: DYNJ9855016V;
4) OPEN HEART, Mo Open, Classified |
LRO | None listed |
| Jun 17, 2026 | Medline Industries, LP MEDLINE Medical Procedure Kits labeled as BIOBURDEN TEST KIT, Kit Uro Robot Cystectomy, etc. (see the recall documents for a full list of products) Open, Classified |
LRO | K213481 |
| Jun 12, 2026 | Medline Industries, LP Medline convenience kits:
ACL PACK
DYNJ64161C
ARTHROSCOPY PACK
DYNJ47103D
DYNJ67197G
DYNJ85197A
DYNJT4007
BASIC ACCESS PACK-LF
DYNJ36698B
BASIC BACK TRAY
DYNJ89037
BASIC PEDI PACK-LF
DYNJ0171446I Open, Classified |
LRO | K213481 |
| Jun 12, 2026 | Medline Industries, LP Medline convenience kits:
DRIVELINE MANAGEMENT KIT
EBSI1688
PORT DRESSING CHANGE KIT
EBSI1328A Open, Classified |
LRO | K213481 |
| Jun 12, 2026 | Medline Industries, LP Medline convenience kits:
20CM CVC INSERTION KIT
ECVC6805B
2L 8.5FR 16CM CVC INSERTION KIT
ECVC8055A
VANTEX PI CVC 7F, 3L, 20CM BUNDLE
ECVC6915A
ECVC6985B Open, Classified |
LRO | K213481 |
| Jun 12, 2026 | Medline Industries, LP Medline convenience kits:
BASIC
DYNJ905869G
BASIC PACK
DYNJ68484B
BIB GENERAL LAPAROSCOPY PA
DYNJ58305
CHRISTUS CH PEDIATRIC BASIC
DYNJ61167G
CVC INSERTION BUNDLE
CVI3940A
DAVINCI PACK SURGICOUN Open, Classified |
LRO | None listed |
| Jun 11, 2026 | AVID Medical, Inc. Halyard, Towel Six Pack. Kit Code: AMTS70-01. Open, Classified |
LRO | None listed |
| Jun 3, 2026 | Windstone Medical Packaging, Inc. Aligned Medical AMS16835 Fluids Kit RX Open, Classified |
LRO | None listed |
| May 28, 2026 | Medline Industries, LP Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as:
1) SPINAL BLOCK TRAY, Medline Kit SKU DYNJRA1097;
2) TRAY, SPINAL PENCIL POINT 25G, Medline Kit SKU DYNJRA Open, Classified |
LRO | K213481 |
| May 8, 2026 | Windstone Medical Packaging, Inc. Custom Convenience Kit containing recalled Medline Namic Angiographic Control Syringes with Rotating Adapter (Namic RA Syringes)
Angio Pack
Part numbers AMS6908E, AMS6908F Open, Classified |
LRO | None listed |
| May 8, 2026 | Medline Industries, LP Medline medical convenience kits, containing Namic Manifold, Labeled as:
1. MTS,RT,HANDED/LFT,HRT,KIT, Medline Kit Number/SKU 60010508;
2. DBD-MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60160075;
Open, Classified |
LRO | None listed |
| May 7, 2026 | Medline Industries, LP See RES for complete list. Medline Convenience Kits: 1) DRAWER 6-IV FLUIDS GLOVES, Model Number: ACC010326; 2) DRAWER 6-IV FLUIDS GLOVES, Model Number: ACC010326A; 3) DRAWER 6-IV FLUIDS GLOVES, Model Open, Classified |
LRO | K213481 K962826 |
| May 6, 2026 | American Contract Systems Inc Convenience kits containing Medline Namic Angiographic Control Syringes with Rotating Adaptor
CORONARY ANGIO PACK
Model numbers ANCA80AP
ANCA80AQ Open, Classified |
LRO | None listed |
| May 6, 2026 | Medical Action Industries, Inc. 306 Medical Action Industries Inc.
Pack Cath BHH,
REF: BHCA49K, Sterile EO, Rx Only, QTY: 5/Case Open, Classified |
LRO | None listed |
| May 1, 2026 | AVID Medical, Inc. Halyard PERC TRAY kit. Model Numbers: SLPC34-01, SLPC34-02. Open, Classified |
LRO | None listed |
| Apr 30, 2026 | Medline Industries, LP Medline and Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as:
1. FOLEY CARE KIT, Medline Kit SKU UROT1044;
2. IV START KIT WITH EXTENSION TUBING, Medline Ki Open, Classified |
LRO | K213481 |
| Apr 30, 2026 | Medline Industries, LP Medline medical procedure kits, containing Medline Neuro Sponges (1050 in total), BIOBURDEN TEST KIT, NEURO, ROBOTIC, ACDF, ENT, etc. Open, Classified |
LRO | None listed |
| Apr 17, 2026 | Medline Industries, LP Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes
ADD A ENDOVASCULAR PACK-LF DYNJ0429339L, DYNJ0429339M
ANGIO ARTERIOGRAM PACK-LF DYNJ0774026K
ANGIO KIT PACK Open, Classified |
LRO | K213481 |
| Apr 17, 2026 | Medline Industries, LP Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes
BASIC CL PACK-LF DYNJ870 Open, Classified |
LRO | None listed |
| Apr 17, 2026 | Medline Industries, LP Medline Kits:
1) NEWBORN ADMISSION, Model Number: DYKB1038;
2) DRAINAGE TRAY, Model Number: DYNDA3188;
3) VA ORLANDO SHOULDER PACK, Model Number: DYNJG001027B;
4) TUMESCENT SYRINGE KIT, Model Numbe Open, Classified |
LRO | None listed |
| Apr 16, 2026 | Medline Industries, LP CENTURION Circumcision Kit, Medline Kit Number/SKU CIT7050F Open, Classified |
LRO | K213481 |
| Apr 7, 2026 | Medline Industries, LP Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows:
1. MTS RH LFT HRT KIT, Medline SKU # 60010508;
2. MTS Open, Classified |
LRO | None listed |
| Apr 1, 2026 | Medline Industries, LP Medline kits containing Olympus biopsy valves:
1. BRONCH PROCEDURE KIT, DYKE2091
2. BRONCHSCOPY, DYNJ900898G DYNJ901922I
3. BRONCHSCOPY PACK, DYNJ38313B
4. BRONCHOSCOPY PACK 0120367-LF, DYNJ32750 Open, Classified |
LRO | K213481 |
| Mar 27, 2026 | Medline Industries, LP Sterile Radiology Procedure Kits, Model Number DYNDH1491B Open, Classified |
LRO | None listed |
| Feb 24, 2026 | Medline Industries, LP Medline kits containing Tego Connectors
Medline APHERESIS SUBQPORT ACCESS KIT
SKU DYNDA2705
Medline CENTRAL LINE INSERTION
SKU DYNJ63347A Open, Classified |
LRO | K213481 |
| Feb 24, 2026 | Medline Industries, LP Convenience kits used for dialysis maintenance
Medline ADD A CATH DIALYSIS KIT
SKU ECVC8415A
Centurion CENTRAL LINE INSERTION TRAY
SKU DT19810
Centurion DIALYSIS BUNDLE WITH NO CATHETTER
SKU CVI431 Open, Classified |
LRO | None listed |
| Feb 24, 2026 | Medline Industries, LP Medline Kits containing Tego Connectors:
Medline IR Pack, SKU DYNJ67205C
Medline NO CATHETER DIALYSIS INSERTION, SKU CVI5200 Open, Classified |
LRO | None listed |
| Feb 20, 2026 | Medline Industries, LP Medline Convenience Kits:
1) TRUNK KIT W/EXPIRATION, Model Number: DYKM1361A;
2) TRUNK KIT 1EA, Model Number: DYKM2013;
3) TRUNK KIT 1EA, Model Number: DYKM2013A;
4) RN TRUNK KIT, Model Number: DYK Open, Classified |
LRO | K112666 |
| Feb 17, 2026 | Medline Industries, LP Medline Surgical Packs:
1) PACK,UNIVERSAL,ULTRAGARD,5/CS, Model Number: DYNJP1050UG;
2) PACK,SHOULDER,DRAPE,POUCH,10/CSModel Number: DYNJP8401 Open, Classified |
LRO | None listed |
| Feb 17, 2026 | Medline Industries, LP Medline Convenience Kits:
1) DRAWER 6-IV FLUIDS GLOVES, Model Number: ACC010326;
2) DRAWER 6-IV FLUIDS GLOVES, Model Number: ACC010326A;
3) DRAWER #5, Model Number: ACC010475;
4) DRAWER 1 NEURO CAR Open, Classified |
LRO | None listed |
| Feb 9, 2026 | AVID Medical, Inc. Halyard TRANSPORT BAG KIT. Kit Code: LIFE0080-01. Open, Classified |
LRO | None listed |
| Feb 9, 2026 | Medline Industries, LP 1) UNIVERSAL KIT, Kit SKU DT22010B;
2) VAD ACCESS KIT, Kit SKU DT22790C;
3) VAD ACCESS KIT, Kit SKU DT22790C;
4) PROCEDURE TRAY, Kit SKU DYNDA2966A;
5) PROCEDURE TRAY, Kit SKU DYNDA2966A;
6) PEDI Open, Classified |
LRO | K213481 |
| Jan 28, 2026 | Medline Industries, LP Medline medical procedure convenience kits labeled as:
1) DRAWER 1 AIRWAY, Kit SKU ACC010270A;
2) DRAWER 2, Kit SKU ACC010690;
3) DRAWER 3 SYR/DRS/MON/NG 1 OF 3, Kit SKU ACC011073;
4) HYPOSPADIUS Open, Classified |
LRO | None listed |
| Jan 14, 2026 | Medline Industries, LP Medline medical procedure convenience kits labeled as:
1) WCH BARI-GASTRECTOMY CDS, REF CDS860237AF;
2) ROBOTIC PROCEDURE, REF CDS982128Q;
3) CUH THORACIC, REF CDS984338M;
4) THORACIC PROCEDURE, Open, Classified |
LRO | None listed |
| Jan 12, 2026 | Medline Industries, LP Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as:
1) DRAWER 2 IV SUPPLIES, Medline kit SKU ACC010271B;
2) DRAWER 2 IV FLUIDS & TUBING, Medline kit SK Open, Classified |
LRO | None listed |
| Jan 2, 2026 | AVID Medical, Inc. Halyard MINI PLUS KIT SOUTH, Kit Code: JACK097-08 Open, Classified |
LRO | None listed |
| Jan 2, 2026 | AVID Medical, Inc. Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOF1000-17. Open, Classified |
LRO | None listed |
| Jan 2, 2026 | AVID Medical, Inc. Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOG1000-15. Open, Classified |
LRO | None listed |
| Dec 23, 2025 | Alcon Research LLC Brand Name: Alcon Laboratories, Inc.
Product Name: Custom Pak
Model/Catalog Numbers: 9903-20, 17188-04, 19762-03, 19203-04, 19203-04, 17957-10
Software Version: N/A
Product Description: Alcon Custom Open, Classified |
LRO | None listed |
| Dec 15, 2025 | AVID Medical, Inc. Halyard, HEAD AND NECK TRAY. Catalog Number: EURO016-09. Open, Classified |
LRO | None listed |
| Dec 15, 2025 | AVID Medical, Inc. Halyard, MAJOR PACK. Catalog Number: JEMJ10-01. Open, Classified |
LRO | None listed |
| Dec 15, 2025 | AVID Medical, Inc. Halyard, MIDTOWN GENERAL ARTERIOGRAM. Catalog Number: EUHM009-01. Open, Classified |
LRO | None listed |
| Dec 15, 2025 | AVID Medical, Inc. Halyard, EP LAB PK. Catalog Number: ESJH009-03. Open, Classified |
LRO | None listed |
| Dec 15, 2025 | AVID Medical, Inc. Halyard, GENERAL LAPAROSCOPY PACK. Catalog Number: VAST018-10. Open, Classified |
LRO | None listed |
| Nov 14, 2025 | Medline Industries, LP MEDLINE convenience kits labeled as:
1) GENERAL LAPAROSCOPY, REF CDS930027W;
2) GENERAL MAJOR CDS, REF CDS980245X;
3) BASIC GENERAL CDS, REF CDS980566F;
4) TOTAL KNEE CDS, REF CDS982823R;
5) BAS Open, Classified |
LRO | None listed |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.