Home › Device types › DWS
Instruments, Surgical, Cardiovascular
FDA product code DWS · Class 1 · Cardiovascular
11,029
Registered devices
845
Adverse events
20
Recalls
71
510(k) clearances
Devices with this code
V. Mueller — STERIS CORPORATIONDELACROIX-CHEVALIER — LANDANGERDELACROIX-CHEVALIER — LANDANGERV. Mueller — STERIS CORPORATIONV. Mueller — STERIS CORPORATIONNovo Surgical — NOVO SURGICAL, INC.ADVANTA SLIDER GDS — Atrium Medical CorporationNovo Surgical — NOVO SURGICAL, INC.ELMED INCORPORATED — ELMED INCORPORATEDNovo Surgical — NOVO SURGICAL, INC.Novo Surgical — NOVO SURGICAL, INC.PILLING — TELEFLEX INCORPORATEDPILLING — TELEFLEX INCORPORATEDPILLING — TELEFLEX INCORPORATEDMSI Precision Specialty Instruments — Med Saver, Inc.Novo Surgical — NOVO SURGICAL, INC.Novo Surgical — NOVO SURGICAL, INC.V. Mueller — STERIS CORPORATIONNovo Surgical — NOVO SURGICAL, INC.Wexler Surgical, Inc. — WEXLER SURGICAL, INC.Integra® Jarit® — INTEGRA LIFESCIENCES PRODUCTION CORPORATIONVASCULAR CLAMP — SONTEC INSTRUMENTS, INC.MSI Precision Specialty Instruments — Med Saver, Inc.LANDANGER — LANDANGER
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-03-27 | Galt Medical Corporation | Due to a potential open seal in the sterile barrier packaging. |
| 2023-07-24 | Cook Vandergrift, Inc. | Sterility of device may be compromised due to breach of the chevron seal of the packaging |
| 2023-06-28 | Maquet Cardiovascular, LLC | The Standard Blade may not securely latch onto the Activator Drive. This may result in the inability to stabilize and position or may result in the loss of stab |
| 2023-06-28 | Maquet Cardiovascular, LLC | The Standard Blade may not securely latch onto the Activator Drive. This may result in the inability to stabilize and position or may result in the loss of stab |
| 2023-06-28 | Maquet Cardiovascular, LLC | The Standard Blade may not securely latch onto the Activator Drive. This may result in the inability to stabilize and position or may result in the loss of stab |
| 2023-06-28 | Maquet Cardiovascular, LLC | The Standard Blade may not securely latch onto the Activator Drive. This may result in the inability to stabilize and position or may result in the loss of stab |
| 2022-02-09 | Maquet Cardiovascular, LLC | Potential for corrosion on the pins of the Ultima Activator II Reusable Drive Mechanism. Harms may include allergic reaction, metal toxicity, and other delayed |
| 2020-02-06 | Deroyal Industries, Inc. Lafollette | The sterile packaging has the potential to be compromised. |
| 2020-01-13 | TELEFLEX MEDICAL INC | There is a potential for the device packaging to become compromised; thus, the sterility of the device cannot be guaranteed. |
| 2020-01-13 | TELEFLEX MEDICAL INC | There is a potential for the device packaging to become compromised; thus, the sterility of the device cannot be guaranteed. |
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