Largo, FL, US · 23 510(k) clearances · 2 PMAs · 16 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Class II | Orthopedic | 6 | 2026-05-13 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | Class II | General, Plastic Surgery | 5 | 2023-10-23 |
| MAI | Fastener, Fixation, Biodegradable, Soft Tissue | Class II | Orthopedic | 2 | 2025-10-15 |
| OWW | — | — | — | 2 | 2024-11-27 |
| HIF | Insufflator, Laparoscopic | Class II | Obstetrics/Gynecology | 2 | 2023-09-20 |
| GCJ | Laparoscope, General & Plastic Surgery | Class II | Gastroenterology, Urology | 2 | 2021-02-19 |
| ORQ | — | — | — | 1 | 2025-04-07 |
| FYD | Apparatus, Exhaust, Surgical | Class II | General, Plastic Surgery | 1 | 2024-08-05 |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | Class II | General, Plastic Surgery | 1 | 2022-05-13 |
| GXY | Electrode, Cutaneous | Class II | Neurology | 1 | 2020-06-01 |
| Date | PMA # | Trade name | Type | Code | Device name | Specialty |
|---|---|---|---|---|---|---|
| 2022-06-16 | P200004-S001 | ConMed PadPro Multifunction Electrodes | 30-Day Notice | MKJ | Automated External Defibrillators (Non-Wearable) | Cardiovascular |
| 2021-09-26 | P200004 | ConMed PadPro Multifunction Electrodes, ConMed PadPro Multifunction Electrode Adapters | Original | MKJ | Automated External Defibrillators (Non-Wearable) | Cardiovascular |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2026-05-14 | Class II | Ongoing | Z-2474-2026 | ConMed AirSeal 12mm Access Port and Palm Grip Obturator with Bladeless Optical Tip, 100mm Length. Catalog Number: iAS12-… | — | Potential for overpressure alerts. |
| 2026-05-14 | Class II | Ongoing | Z-2473-2026 | ConMed AirSeal 12mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 120mm Length. Catalog Number: iAS1… | — | Potential for overpressure alerts. |
| 2026-05-14 | Class II | Ongoing | Z-2472-2026 | ConMed AirSeal 12mm Access Port and Palm Grip Obturator with Bladeless Optical Tip, 150mm Length. Catalog Number: iAS12-… | — | Potential for overpressure alerts. |
| 2026-05-14 | Class II | Ongoing | Z-2471-2026 | ConMed AirSeal 5mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 100mm Length. Catalog Number: iAS5-… | — | Potential for overpressure alerts. |
| 2026-05-14 | Class II | Ongoing | Z-2470-2026 | ConMed AirSeal 5mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 120mm Length. Catalog Number: iAS5-… | — | Potential for overpressure alerts. |
| 2026-05-14 | Class II | Ongoing | Z-2469-2026 | ConMed AirSeal 5mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 75mm Length. Catalog Number: iAS5-7… | — | Potential for overpressure alerts. |
| 2026-05-14 | Class II | Ongoing | Z-2468-2026 | ConMed AirSeal 8mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 100mm Length. Catalog Number: iAS8-… | — | Potential for overpressure alerts. |
| 2026-05-14 | Class II | Ongoing | Z-2467-2026 | ConMed AirSeal 8mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 120mm Length. Catalog Number: iAS8-… | — | Potential for overpressure alerts. |
| 2026-05-14 | Class II | Ongoing | Z-2466-2026 | ConMed AirSeal 12mm Access Port and Obturator with Blunt Tip, 100mm Length. Catalog Number: iASB12-100. 6 units per pack… | — | Potential for overpressure alerts. |
| 2026-05-14 | Class II | Ongoing | Z-2465-2026 | ConMed AirSeal 12 mm Access Port and Obturator with Blunt Tip, 120mm Length. Catalog Number: iASB12-120. 6 units per pac… | — | Potential for overpressure alerts. |
| 2026-05-14 | Class II | Ongoing | Z-2464-2026 | ConMed AirSeal 5 mm Smooth Access Port and Obturator with Blunt Tip, 150mm Length. Catalog Number: iASB5-150. 6 units pe… | — | Potential for overpressure alerts. |
| 2022-11-18 | Class II | Terminated | Z-0474-2023 | Foot Controlled Electrosurgical Suction Coagulator, Electrosurgical Suction Coagulator 10FR, Catalog Number 130187 | — | Suction ports may potentially be occluded on the affected devices. If this occurs, the affected devices will not be able to perform the suction function during … |
| 2021-03-26 | Class II | Terminated | Z-1499-2021 | KIT_INFINITY_BASE Custom Procedural Kit - Italy, containing Infinity ACL Tibial Elbow and Tip Guides product line, KTE10… | — | Tip Guides are potentially misaligned laterally which could affect the accuracy of the guide system and could cause a delay in procedure and may require another… |
| 2021-03-26 | Class II | Terminated | Z-1498-2021 | INFINITY_TRAY Custom Procedural Kit - Canada. containing Infinity ACL Tibial Elbow and Tip Guides product line, KTE100… | — | Tip Guides are potentially misaligned laterally which could affect the accuracy of the guide system and could cause a delay in procedure and may require another… |
| 2020-11-12 | Class II | Terminated | Z-0651-2021 | Infinity ACL Tibial Tip Guide- indicated for use in open and arthroscopic procedures for knee ligament reconstruction. … | — | Tips of the Infinity ACL Tibial Elbow and Tip Guides are potentially misaligned laterally which could affect the accuracy of the guide system |
| 2020-11-12 | Class II | Terminated | Z-0650-2021 | Infinity ACL Tibial Elbow Guide-indicated for use in open and arthroscopic procedures for knee ligament reconstruction. … | — | Tips of the Infinity ACL Tibial Elbow and Tip Guides are potentially misaligned laterally which could affect the accuracy of the guide system |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-05-13 | K261363 | Y-Knotless Flex Anchors | MBI | Class II | Orthopedic |
| 2026-01-29 | K253763 | Y-Knotless Flex Anchors | MBI | Class II | Orthopedic |
| 2025-10-15 | K252946 | BioBrace® Extra-Articular Ligament Augmentation Kit | MAI | Class II | Orthopedic |
| 2025-06-18 | K251530 | CONMED Argo Knotless® Anchor | MBI | Class II | Orthopedic |
| 2025-04-07 | K250395 | BioBrace ® RC Delivery System | ORQ | — | — |
| 2025-01-28 | K244025 | Argo Knotless GENESYS Anchor | MBI | Class II | Orthopedic |
| 2024-11-27 | K242187 | BioBrace® | OWW | — | — |
| 2024-08-05 | K240127 | PlumeSafe X5 Smoke Management System | FYD | Class II | General, Plastic Surgery |
| 2024-07-29 | K241906 | BioBrace® Reinforced Implant | OWW | — | — |
| 2024-03-05 | K240090 | Argo Knotless GENESYS Anchor | MAI | Class II | Orthopedic |
| 2023-10-23 | K231732 | CleanSeal Advanced Bipolar Vessel Sealer Maryland | GEI | Class II | General, Plastic Surgery |
| 2023-09-20 | K230239 | AirSeal iFS System; AirSeal dV Solution | HIF | Class II | Obstetrics/Gynecology |
| 2023-04-27 | K230547 | PlumePen Elite Surgical Smoke Evacuation Pencils, PlumePen Pro Surgical Smoke Evacuation Pencil, PlumePen Ultra Surgical Smoke Evacuation Pencils, PenAdapt Electrosurgical Pencil Adapter, SnapEvac Electrosurgical Pencil Adapter | GEI | Class II | General, Plastic Surgery |
| 2022-08-26 | K214058 | Beamer AVEO Electrosurgical Generator, Beamer AVEO Argon Module, Beamer AVEO Cart, Beamer AVEO Wired Foot Pedal, Beamer AVEO Argon Pressure Reducer | GEI | Class II | General, Plastic Surgery |
| 2022-07-28 | K221945 | Beamer AVEO FILTER INTEGRATED ARGON PROBE 1.8mm x 160 cm, Beamer AVEO FILTER INTEGRATED ARGON PROBE 1.8 mm X 320 cm, Beamer AVEO FILTER INTEGRATED ARGON PROBE 2.3 mm X 230 cm, Beamer AVEO FILTER INTEGRATED ARGON PROBE 2.3 mm x 320 cm, Beamer AVEO FILTER INTEGRATED ARGON SIDEFIRE PROBE 2.3 mm x 230 cm | GEI | Class II | General, Plastic Surgery |
| 2022-05-13 | K220757 | Argo Knotless SP Anchor | MBI | Class II | Orthopedic |
| 2022-05-13 | K220186 | Zone Specific AIM | GAT | Class II | General, Plastic Surgery |
| 2022-03-11 | K213354 | Unify Multifunction Energy Platform, CleanSeal Vessel Sealers, Unify Bipolar Resection Cables, Unify Wireless FootSwitch, Unify Cart | GEI | Class II | General, Plastic Surgery |
| 2021-08-19 | K211104 | AirSeal® dV Solution- AirSeal® Cannula Cap and AirSeal® Bifurcated Filtered Tube Set | HIF | Class II | Obstetrics/Gynecology |
| 2021-02-19 | K202303 | CORE E3 Suction/irrigator | GCJ | Class II | Gastroenterology, Urology |
| 2020-07-08 | K201593 | Looking Glass 4K Integrated Visualization System | GCJ | Class II | Gastroenterology, Urology |
| 2020-06-01 | K200540 | BRAINSTREAM Disposable Deep Cup EEG Electrodes | GXY | Class II | Neurology |
| 2020-01-22 | K193606 | Y-Knot OneStep Anchor | MBI | Class II | Orthopedic |