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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Liko Standard Slingbar 450. The Standard Slingbar 450 is a versatile sling bar which can be used for most lifting situations. It can be used with different Liko ceiling and mobile lifts.
FDA Enforcement
Class II
·Terminated·Hill-Rom, Inc.·January 9, 2013
Omnipod DASH Insulin Management System (mg/dL configuration), Catalog Number PT000010 M/D: INT1D001MG - Product Usage: is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin.
FDA Enforcement
Class II
·Terminated·Insulet Corporation·June 10, 2020
***REF #200***TAPSCOPE 550. Each pouch contains one (1) 18 French esophageal stethoscope with bipolar pacing and recording electrodes with a YSI 400 series male connector thermistor. LOT xxxxxxx 400095-0200-C 100902. www.cardiocommand.com. ***REF #200-0010***TAPSCOPE 550 CONTAINS: Ten (10) 18 French esophageal stethoscopes with bipolar pacing and recording electrodes with YSI 400 series male connector thermistors. NON-STERILE. SINGLE USE ONLY. DO NOT REUSE. CAUTION: Federal (U.S.A.) law restricts this device to sale, distribution and use by or on the order of a licensed physician. Manufacturer: CARDIOCOMMAND, INC. Tampa, FL USA. (800) 231-6370 (813) 289-5555. www.cardiocommand.com. LOT xxxxxxx 400155-B 091101. ***REF #200-0025***TAPSCOPE 550 Contains: Twenty five (25) 18 French esophageal stethoscopes with bipolar pacing and recording electrodes with YSI 400 series male connector thermistors. ***LOT xxxxxxx***FOR SINGLE USE ONLY. DO NOT REUSE. NON-STERILE. CAUTION: Federal (U.S.A.) law restricts this device to sale, distribution and use by or on the order of a licensed physician. Read Model 2A operator's manual prior to initiating pacing procedures. Manufacturer: Tampa, FL USA 33607. (800) 231-6370 (813) 289-5555. www.cardiocommand.com. 400215-A 100902.
FDA Recall
Terminated
·Cardiocommand Inc.·Product code LPA·October 25, 2010
Omnipod DASH Personal Diabetes Manager (PDM), Catalog numbers US: 18239 M/D: PDM-USA1-D001-MG-USA1 EU: PT-000010 - M/D: INT1-D001-MG PT-000011 M/D: INT1-D001-MM UDI 10385082000009 The Omnipod DASH Personal Diabetes Manager (PDM) is a mobile, handheld Android device that is intended to communicate with the Omnipod DASH Pod (pump).
FDA Enforcement
Class II
·Terminated·Insulet Corporation·April 1, 2020
18239: ASM Omnipod Dash PDM, insulin delivery system. PT-000010: Assembly, Dash Final PDM U100, mg/dL PT-000011: Assembly, Dash Final PDM U100, mmol/L PT-000030: Assembly, DASH PDM, Canada Remote Controller (Personal Diabetes Manager or PDM) associated with Insulin Pump (Pod) *The part numbers above may be incorporated into higher level assemblies such as DASH Starter Kits.
FDA Enforcement
Class I
·Terminated·Insulet Corporation·November 23, 2022