90 results
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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The product is a handheld ultraviolet-C germicidal wand and contains two, narrow-diameter, tubular lamps with a peak emission wavelength in the 254 nm range with an intended use of disinfecting surfaces.
FDA Enforcement
Class II
·Ongoing·MAX LUX CORP·December 8, 2021
AESCULAP ELAN 4 FIXED DURAGUARD STANDARD. Model Number: GB942R.
FDA Enforcement
Class II
·Ongoing·Aesculap AG·October 8, 2025
AESCULAP ELAN 4 FIXED DURAGUARD LONG. Model Number: GB943R.
FDA Enforcement
Class II
·Ongoing·Aesculap AG·October 8, 2025
The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 9, 2020
S-Series Equipment Management System; Model Number(s):0682400550; UDI: 07613327400502 Components that are affected within the S-Series Finished Good Model Number o P38198 - ASM, MFR CONTROLLER, FIXED STANDARD o P38199 - ASM, MFR CONTROLLER, LIFT STANDARD o P40553 - ASM, MFR HANDLE REPAIR, LIFTING, S-SERIES, STANDARD o P40554 - ASM, MFR HANDLE REPAIR, FIXED, S-SERIES, STANDARD o P46269 - ASSY, MFR CONTROLLER UPGRADE, STANDARD
FDA Enforcement
Class II
·Ongoing·Stryker Communications·March 31, 2021
MEDICAL CHEMICAL CORPORATION Total-Fix STOOL COLL KIT, TOTAL FIX PARASITOLOGY (100/CS) Catalog # NC0585129
FDA Enforcement
Class II
·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·August 31, 2022
LOSPA Tibial Insert Model/Catalog Number: See below Software Version: N/A Product Description: Tibial Insert
FDA Enforcement
Class II
·Ongoing·CORENTEC CO., LTD·June 12, 2024
Brand Name: Meridian Angled Awl Fixed Product Name: Angled Awl Fixed Model/Catalog Number: RA2-003015 Product Description: Surgical Awl Component: No
FDA Enforcement
Class II
·Ongoing·SEASPINE ORTHOPEDICS CORPORATION·July 24, 2024
PERIFIX FX Continuous Epidural Anesthesia Tray, 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Fixed Wings, 19 Ga. Open tip PERIFIX FX Springwound Epidural Catheter. Product Code: CE17TKFSDT. Product Description: CE17TKFSDT EPID TRAY W/17GA FIXED WING.
FDA Enforcement
Class II
·Ongoing·B BRAUN MEDICAL INC·October 15, 2025
Azurion IGTS Fixed Systems
FDA Enforcement
Class II
·Ongoing·Philips North America·November 15, 2023
Allura Xper IGTS Fixed Systems
FDA Enforcement
Class II
·Ongoing·Philips North America·November 15, 2023
Integris-Allura IGTS Fixed Systems
FDA Enforcement
Class II
·Ongoing·Philips North America·November 15, 2023
IntelliVue Patient Monitor MX400 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866060. Indicated for use by health care professionals for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates.
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·August 14, 2024
IntelliVue Patient Monitor MX550 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866066. Indicated for use by health care professionals for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates.
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·August 14, 2024
IntelliVue Patient Monitor MX450 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866062. Indicated for use by health care professionals for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates.
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·August 14, 2024
IntelliVue Patient Monitor MX500 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866064. Indicated for use by health care professionals for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates.
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·August 14, 2024
ULTRA FAST-FIX AB ASSEMBLY - STRAIGHT-Absorbable Suture anchors Product Number: 72201493
FDA Enforcement
Class II
·Ongoing·Smith & Nephew, Inc.·October 28, 2020
ULTRA FAST-FIX AB ASSEMBLY - CURVED-Absorbable Suture anchors Product Number: 72201494
FDA Enforcement
Class II
·Ongoing·Smith & Nephew, Inc.·October 28, 2020
ATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP Technology, Size 6. Component of the ATTUNE Total Knee Replacement System.
FDA Enforcement
Class II
·Ongoing·DePuy Orthopaedics, Inc.·April 10, 2024
ULTRA FAST-FIX AB ASSEMBLY-REVERSE CURVE-Absorbable Suture anchor Product Number: 72201495
FDA Enforcement
Class II
·Ongoing·Smith & Nephew, Inc.·October 28, 2020