Panels › General, Plastic Surgery › Product code KDD · Class 1
Kit, Surgical Instrument, Disposable
Regulation 878.4800
0510(k)s in 12 months (62 all time)
16recalls in 12 months (252 all time)
9recalls that name a 510(k)
Top companies in KDD
| Company | 510(k)s | Recalls |
|---|---|---|
| Beaver Visitec International, Inc. | 0 | 160 |
| Windstone Medical Packaging, Inc. | 0 | 17 |
| MEDLINE INDUSTRIES, LP - Northfield | 0 | 13 |
| Biomet Microfixation, Inc. | 0 | 9 |
| Medline Industries, LP | 0 | 9 |
| ARROW INTERNATIONAL, LLC | 0 | 6 |
| Deroyal Industries, Inc. | 1 | 5 |
| Bioseal Corporation | 0 | 4 |
| Merit Medical Systems, Inc. | 0 | 4 |
| MICROspecialties, Inc. | 0 | 4 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 15, 2026 | Medline Industries, LP Medline surgical convenience kits labeled as:
1) CV BASIN PACK-LF, Medline Product number/SKU DYNJ0538615K;
2) CV BASIN PACK-LF, Medline product number/SKU DYNJ0538615J;
3) CV BASIN PACK-LF, Medl Open, Classified |
KDD | None listed |
| Sep 10, 2026 | Windstone Medical Packaging, Inc. AMS Convenience Kit:
DSAEK Pack - RX, Part Number AMS12394B Open, Classified |
KDD | None listed |
| Aug 31, 2026 | Medline Industries, LP Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators
BASIN PACK-LF
DYNJ42828B
EYE BASIN TRAY-LF
DYNJ42832B Open, Classified |
KDD | None listed |
| Jun 29, 2026 | Medline Industries, LP Medline Convenience Kits:
1) SUTURING SET, Model Number: SUT13710 Open, Classified |
KDD | None listed |
| Jun 25, 2026 | Medline Industries, LP Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes.
MAJOR BASIN SET
DYNJ85723 Open, Classified |
KDD | None listed |
| Jun 17, 2026 | Medline Industries, LP MEDLINE Medical Procedure Kits labeled as:
1) CV DRAPING/BASIN, Medline Kit Number/SKU DYNJ908483A;
2) CV DRAPING/BASIN, Medline Kit Number/SKU DYNJ908483B;
3) CV DRAPING/BASIN, Medline Kit Number Open, Classified |
KDD | None listed |
| Jun 13, 2026 | ARROW INTERNATIONAL, LLC Description/REF:
PARACENTESIS KIT/ASK-00376-JHH Open, Classified |
KDD | K874063 |
| May 7, 2026 | Medline Industries, LP Medline Convenience Kits:
1) LITHOTOMY PACK, Model Number: DYNJ83185;
2) LITHOTOMY PACK, Model Number: DYNJ83185A;
3) LAP BASIN, Model Number: DYNJVB91109D Open, Classified |
KDD | None listed |
| Apr 30, 2026 | Medline Industries, LP Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows:
1. NEURO BASIN PACK-LF, Medline Kit Number/SKU DYNJ0532910L;
2. NEURO BASIN PACK-LF, Medline Kit Number/SKU DYN Open, Classified |
KDD | None listed |
| Apr 22, 2026 | Windstone Medical Packaging, Inc. Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994A Open, Classified |
KDD | None listed |
| Apr 22, 2026 | Windstone Medical Packaging, Inc. Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994 Open, Classified |
KDD | None listed |
| Apr 22, 2026 | Windstone Medical Packaging, Inc. Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14433 Open, Classified |
KDD | None listed |
| Feb 17, 2026 | Medline Industries, LP Medline Convenience Kits:
1) LITHOTOMY PACK, Model Number: DYNJ83185;
2) LITHOTOMY PACK, Model Number: DYNJ83185A; Open, Classified |
KDD | None listed |
| Feb 4, 2026 | Vortex Surgical Inc. Vortex Surgical I2 Injection Kit, VS0500 Open, Classified |
KDD | None listed |
| Feb 4, 2026 | Vortex Surgical Inc. Convenience Kits
1. 25GA Convenience Kit - FNX
VS0644.25-FNX
2. 25GA Convenience Kit - FXX
VS0644.25-FXX
3.25GA Convenience Kit - XES
VS0644.25-XES Open, Classified |
KDD | None listed |
| Nov 14, 2025 | Medline Industries, LP MEDLINE convenience kits labeled as:
1) MINOR SINGLE BASIN PACK, REF DYNJ37698L;
2) BASIN PACK, REF DYNJ50123D;
3) MAJOR BASIN PACK, REF DYNJ59816A;
4) OSC BASIN PACK, REF DYNJ68217A. Open, Classified |
KDD | None listed |
| Apr 17, 2025 | MEDLINE INDUSTRIES, LP - Northfield Medline Convenience kits used for various procedures:
1) MINOR BASIN -SMH, Model Number: DYNJ907733B Open, Classified |
KDD | None listed |
| Apr 4, 2025 | MEDLINE INDUSTRIES, LP - Northfield Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows:
HEART BASIN PACK-LF Open, Classified |
KDD | None listed |
| Mar 26, 2025 | MEDLINE INDUSTRIES, LP - Northfield Medline procedure kits labeled as:
1) ANGIOGRAPHY SPECIALS Open, Classified |
KDD | None listed |
| Dec 30, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline custom medical procedure kits labeled as:
1) NEURO BASIN PACK-LF, REF DYNJ39461J;
2) NEURO BASIN KIT, REF DYNJ80200B. Open, Classified |
KDD | None listed |
| Dec 5, 2024 | MEDLINE INDUSTRIES, LP - Northfield MEDLINE convenience kits labeled as:
1) LAKELAND SINGLE BASIN PACK-LF, REF DYNJ0619907I;
2) LAKELAND SINGLE BASIN PACK-LF, REF DYNJ0619907K;
3) LKLND SNGL BASIN PK RFID-LF, REF DYNJ0619907L;
4) B Open, Classified |
KDD | None listed |
| Nov 15, 2024 | Biomet, Inc. JuggerLoc/ToggleLoc 2.9mm Drill Guide, Model number 110027357 Open, Classified |
KDD | None listed |
| Nov 5, 2024 | DeRoyal Industries Inc DeRoyal C-SECTION TRACEPACK, REF 89-9338-06 Open, Classified |
KDD | None listed |
| Oct 23, 2024 | MEDLINE INDUSTRIES, LP - Northfield Centurion EP LAB INSTRUMENT KIT, REF MNS10480; medical procedure convenience kit Open, Classified |
KDD | None listed |
| Sep 6, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline Convenience kits labeled as:
1) GER ARTH BASIN PK RFID-LF , Pack Number DYNJ0100999K ;
2) PEDIATRIC MAJOR BASIN PACK-LF , Pack Number DYNJ0154061C ;
3) EYE BASIN PACK-LF , Pack Number DYNJ Open, Classified |
KDD | None listed |
| Aug 28, 2024 | Beaver Visitec International, Inc. BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58002080; Open, Classified |
KDD | None listed |
| Aug 28, 2024 | Beaver Visitec International, Inc. BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58002078; Open, Classified |
KDD | None listed |
| Aug 28, 2024 | Beaver Visitec International, Inc. BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58002075; Open, Classified |
KDD | None listed |
| Aug 28, 2024 | Beaver Visitec International, Inc. BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58002074; Open, Classified |
KDD | None listed |
| Aug 28, 2024 | Beaver Visitec International, Inc. BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58002063; Open, Classified |
KDD | None listed |
| Aug 28, 2024 | Beaver Visitec International, Inc. BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58002042; Open, Classified |
KDD | None listed |
| Aug 28, 2024 | Beaver Visitec International, Inc. BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58002000; Open, Classified |
KDD | None listed |
| Aug 28, 2024 | Beaver Visitec International, Inc. BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001999; Open, Classified |
KDD | None listed |
| Aug 28, 2024 | Beaver Visitec International, Inc. BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001973; Open, Classified |
KDD | None listed |
| Aug 28, 2024 | Beaver Visitec International, Inc. BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001970; Open, Classified |
KDD | None listed |
| Aug 28, 2024 | Beaver Visitec International, Inc. BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001967; Open, Classified |
KDD | None listed |
| Aug 28, 2024 | Beaver Visitec International, Inc. BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001944; Open, Classified |
KDD | None listed |
| Aug 28, 2024 | Beaver Visitec International, Inc. BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001943; Open, Classified |
KDD | None listed |
| Aug 28, 2024 | Beaver Visitec International, Inc. BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001934; Open, Classified |
KDD | None listed |
| Aug 28, 2024 | Beaver Visitec International, Inc. BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001933; Open, Classified |
KDD | None listed |
| Aug 28, 2024 | Beaver Visitec International, Inc. BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001928; Open, Classified |
KDD | None listed |
| Aug 28, 2024 | Beaver Visitec International, Inc. BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001878; Open, Classified |
KDD | None listed |
| Aug 28, 2024 | Beaver Visitec International, Inc. BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001876; Open, Classified |
KDD | None listed |
| Aug 28, 2024 | Beaver Visitec International, Inc. BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001865; Open, Classified |
KDD | None listed |
| Aug 28, 2024 | Beaver Visitec International, Inc. BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001845; Open, Classified |
KDD | None listed |
| Aug 28, 2024 | Beaver Visitec International, Inc. BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001838; Open, Classified |
KDD | None listed |
| Aug 28, 2024 | Beaver Visitec International, Inc. BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001836; Open, Classified |
KDD | None listed |
| Aug 28, 2024 | Beaver Visitec International, Inc. BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001825; Open, Classified |
KDD | None listed |
| Aug 28, 2024 | Beaver Visitec International, Inc. BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001818; Open, Classified |
KDD | None listed |
| Aug 28, 2024 | Beaver Visitec International, Inc. BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001809; Open, Classified |
KDD | None listed |
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