38 results
·
28ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ASAHI Corsair Armet
FDA 510(k)
FDA Class 2
·Cardiovascular
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW)
FDA 510(k)
FDA Class 1
·General Hospital
PIGALILEO TOTAL KNEE REPLACEMENT (TKR) SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 10, 2014
PINNACLE 100 ACET CUP 56MM
FDA Adverse Event
Injury
·1818910 DEPUY ORTHOPAEDICS, INC.·Product code KWA·June 11, 2013
INFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·July 13, 2011
AZUR SOFT3D DETACHABLE 10
FDA Adverse Event
Malfunction
·MICROVENTION, INC.·Product code KRD·April 20, 2026
AZUR SOFT3D DETACHABLE 10
FDA Adverse Event
Injury
·MICROVENTION, INC.·Product code KRD·April 17, 2026
AZUR SOFT3D DETACHABLE 10
FDA Adverse Event
Injury
·MICROVENTION, INC.·Product code KRD·April 3, 2026
Jackson-Pratt Hemaduct Cardiothoracic Silicone Round Drain,19FR. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section of tubing which has perforations or ducts. The wound drain is surgically placed in a surgical wound site using a trocar. Blood and fluids are collected through a wound drain into a fluid collection reservoir. Wound drains are used to remove exudates from wound sites. Trocars, drains and reservoirs are for a single patient use only and should be discarded after use
FDA Enforcement
Class II
·Terminated·Cardinal Health 200, LLC·May 31, 2017
AZUR SOFT3D DETACHABLE 10
FDA Adverse Event
Malfunction
·MICROVENTION, INC.·Product code KRD·April 24, 2026
AZUR SOFT3D DETACHABLE 10
FDA Adverse Event
Injury
·MICROVENTION INC.·Product code KRD·January 14, 2025
AZUR SOFT3D DETACHABLE 10
FDA Adverse Event
Malfunction
·MICROVENTION, INC.·Product code HCG·May 28, 2026
AZUR SOFT3D DETACHABLE 10
FDA Adverse Event
Malfunction
·MICROVENTION, INC.·Product code KRD·October 16, 2024
AZUR SOFT3D DETACHABLE 10
FDA Adverse Event
Malfunction
·MICROVENTION INC.·Product code KRD·September 15, 2024
AZUR SOFT3D DETACHABLE 10
FDA Adverse Event
Injury
·MICROVENTION, INC·Product code HCG·May 2, 2024
AZUR SOFT3D DETACHABLE 10
FDA Adverse Event
Malfunction
·MICROVERSION, INC.·Product code KRD·February 28, 2024
AZUR SOFT3D DETACHABLE 10
FDA Adverse Event
Malfunction
·MICROVENTION, INC.·Product code KRD·June 2, 2023
AZUR SOFT3D DETACHABLE 10
FDA Adverse Event
Malfunction
·MICROVENTION, INC.·Product code KRD·May 8, 2026
AZUR SOFT3D DETACHABLE 10
FDA Adverse Event
Malfunction
·MICROVENTION, INC.·Product code KRD·January 16, 2024