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) |
|---|---|---|---|
| Aug 28, 2024 | Beaver Visitec International, Inc. BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000568; 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: 58000567; 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: 58000508; 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: 58000501; 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: 58000479; 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: 58000477; 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: 58000455; 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: 58000426; 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: 58000404; 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: 58000305; 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: 58000288; 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: 58000287; 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: 58000266; 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: 58000195; 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: 58000192; 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: 58000168; 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: 58000162; 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: 58000126; 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: 58000120; 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: 58000056; 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: 58000023; 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: 584785; 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: 584770; 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: 584742; 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: 584727; 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: 584712; 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: 584643; 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: 584630; 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: 584625; 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: 584587; 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: 584550; 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: 584545; 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: 584404; 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: 584003; Open, Classified |
KDD | None listed |
| Jul 11, 2024 | MICROspecialties, Inc. Synergetics I Pack Injection Kit with Wire Speculum- Tray for use in Opthalmic Injection
Model/Catalog Number: 18069W Open, Classified |
KDD | None listed |
| Jul 11, 2024 | MICROspecialties, Inc. Synergetics I Pack Injection Kit Custom-Tray for use with Ophthalmic injections
Model/Catalog Number: 18069
Product Description: Open, Classified |
KDD | None listed |
| Jul 11, 2024 | MICROspecialties, Inc. Synergetics I-Pack Injection Kit with Drape -For use with Ophthalmic injections
Model/Catalog Number: 18061 Open, Classified |
KDD | None listed |
| Jul 11, 2024 | MICROspecialties, Inc. Synergetics I Pack Injection Kit- Tray for use with Ophthalmic injections
Model/Catalog Number: 18060 Open, Classified |
KDD | None listed |
| Jul 11, 2024 | Synergetics Inc BAUSCH+LOMB, I-PACK Injection Kit with Wire Speculum, REF 18069W, for the administration of intravitreal injection (eye) Open, Classified |
KDD | None listed |
| Jul 11, 2024 | Synergetics Inc BAUSCH+LOMB, I-PACK Injection Kit Custom, REF 18069, for the administration of intravitreal injection (eye) Open, Classified |
KDD | None listed |
| Jul 11, 2024 | Synergetics Inc BAUSCH+LOMB, I-PACK Injection Kit with Drape, REF 18061, for the administration of intravitreal injection (eye) Open, Classified |
KDD | None listed |
| Jul 11, 2024 | Synergetics Inc BAUSCH+LOMB, I-PACK Injection Kit, REF 18060, for the administration of intravitreal injection (eye) Open, Classified |
KDD | None listed |
| Apr 29, 2024 | Allergan Sales, LLC Keller Funnel 2, REF: HA-001, STERILEEO, Rx Only, Open, Classified |
KDD | None listed |
| Mar 29, 2024 | MEDLINE INDUSTRIES, LP - Northfield Centurion manual surgical kits labeled as:
a) ST. VIRTUS SPLINTER FORCEP 6" (SF8246), Product Code 66580;
b) DEBRIDEMENT TRAY, Product Code I86630;
c) BIOPSY INSTRUMENT PACK, Product Code I86690;
Open, Classified |
KDD | None listed |
| Feb 25, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline Kits, trays, and packs labeled as follows:
CHP WOUND IRRIGATION KIT, REF DYK1017614W Open, Classified |
KDD | None listed |
| Feb 16, 2024 | Windstone Medical Packaging, Inc. Aligned Medical Solutions, Closure Kit, AMS13043, STERILEEO Open, Classified |
KDD | None listed |
| Feb 16, 2024 | Windstone Medical Packaging, Inc. Aligned Medical Solutions, In House Ocular Pack, AMS12947, STERILEEO Open, Classified |
KDD | None listed |
| Feb 16, 2024 | Windstone Medical Packaging, Inc. Aligned Medical Solutions, In House Ocular Pack, AMS12947A STERILEEO Open, Classified |
KDD | None listed |
| Feb 16, 2024 | Windstone Medical Packaging, Inc. Aligned Medical Solutions, Local Lower Extremity Pack I, AMS10833, STERILEEO Open, Classified |
KDD | None listed |
| Nov 9, 2023 | Stryker Corporation Stryker, REF: CAT00241, Portal Entry Kit consisting of a skin marker, disposable ruler, (2) FlexSticks, 30 ml syringe, and (2) 17 Ga Needles. Used to aid the surgeon in
establishing arthroscopic porta Open, Classified |
KDD | None listed |
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