Entity profile compiled from public source records
| Submission # | Device Name | Decision Date | Decision Description | Action |
|---|---|---|---|---|
| K083325 | N-600X WITH SPD, OXIMAX N-600X | 2009-03-09 | Substantially Equivalent | View Details |
| K091762 | DURA-STICK SELF-ADHESIVE ELECTRODES WITH ALOE | 2009-12-22 | Substantially Equivalent | View Details |
| K100306 | KENDALL SCD SEQUENTIAL COMPRESSION COMFORT SLEEVES | 2010-05-04 | Substantially Equivalent | View Details |
| K111817 | PALINDROME RT CHRONIC CATHETER | 2011-08-30 | Unknown | View Details |
| K112536 | SONICISION STERILIZATION TRAY | 2012-04-19 | Substantially Equivalent | View Details |
| K130320 | BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM, BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM WITH RESPIRATION RATE SOFTW | 2014-02-04 | Substantially Equivalent | View Details |
| K130796 | VITAL SYNC INFORMATICS MANAGER & VIRTUAL PATIENT MONITORING PLATFORM | 2013-05-09 | Substantially Equivalent | View Details |
| K142296 | Shiley Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner Cannula; Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Disposable Inner Cannula | 2015-02-24 | Substantially Equivalent | View Details |
| K142298 | Shiley Neonatal, Pediatric & Pediatric Long Tracheostomy Tubes with TaperGuard Cuff | 2015-02-13 | Substantially Equivalent | View Details |
| K142547 | Bluntport Blunt Trocar with Threaded Anchor 5mm-12mm | 2014-12-09 | Substantially Equivalent | View Details |
| K142934 | CrossCountry Transbronchial Access Tool straight, CrossCountry Transbronchial Access Tool curved | 2015-06-17 | Substantially Equivalent | View Details |
| K143088 | GastriSail Gastric Positioning System | 2015-02-25 | Substantially Equivalent | View Details |
| K162584 | VersaOne Bladeless Trocar | 2016-10-18 | Substantially Equivalent | View Details |
| K170869 | LigaSure Maryland Jaw Sealer/Divider One-step Sealing, Nano-coated | 2017-04-21 | Substantially Equivalent | View Details |
| K172482 | The Nellcor pulse oximetry monitor interface cable | 2017-12-15 | Substantially Equivalent | View Details |
| K180622 | Kangaroo Gastrostomy Feeding Tube with ENFit Y-Port | 2018-10-23 | Substantially Equivalent | View Details |
| K180915 | Sonicision Reusable Sterilization Tray | 2018-07-17 | Substantially Equivalent | View Details |
| K181085 | LigaSure Maryland Jaw Thoracic Sealer/Divider One-step Sealing, Nano-coated | 2018-06-21 | Substantially Equivalent | View Details |
| K182772 | Valleylab Smoke Evacuation Rocker Switch Pencil , Valleylab Telescoping Smoke Evacuation Rocker Switch Pencil | 2018-11-19 | Substantially Equivalent | View Details |
| K182861 | Shiley Neonatal/Pediatric Tracheostomy Tube | 2019-03-22 | Substantially Equivalent | View Details |
| K191601 | Valleylab FT10 Electrosurgical Platform | 2019-07-12 | Substantially Equivalent | View Details |
| K220540 | ProGrip Self-Gripping Polypropylene Mesh | 2022-09-22 | Substantially Equivalent | View Details |
| K221006 | GIA Stapler with Tri-Staple Technology | 2022-04-29 | Substantially Equivalent | View Details |
| K221629 | Tri-Staple 2.0 Black Circular Reloads (for use with Signia Circular Adapters) | 2023-02-22 | Substantially Equivalent | View Details |
| K231491 | TA Stapler and Loading Unit with DST Series Technology | 2023-08-16 | Substantially Equivalent | View Details |
| K241486 | Sofsilk Coated Braided Silk Suture | 2024-12-03 | Substantially Equivalent | View Details |
| Recall # | Product Description | Initiation Date | Status | Action |
|---|---|---|---|---|
| Z-0144-2024 | Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000 Reason: Defective video laryngoscopes that did not pass quality tests established for the product, that were designated for destruction, were stolen, and subsequently distributed for sale. Defective device use may result in failed laryngoscopy and/or intubation. | 2023-09-28 | Open, Classified | View Details |
| Z-0168-2024 | McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-017-000, Sterile EO, Rx Only Reason: Laryngoscope blades may contain an ineffective application of anti-fog agent which may result in condensation accumulating causing the screen to be blurred or obscured. | 2023-08-10 | Open, Classified | View Details |
| Z-0169-2024 | McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-084-000, Sterile EO, Rx Only Reason: Laryngoscope blades may contain an ineffective application of anti-fog agent which may result in condensation accumulating causing the screen to be blurred or obscured. | 2023-08-10 | Open, Classified | View Details |
AvaSpecs compiles public data records from the FDA database. This compiled profile does not indicate endorsement, safety, clearance, approval, or compliance status. AvaSpecs is a private search index and is not affiliated with the FDA or any government agency.