16 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VSI Micro-Introducer Kit
FDA 510(k)
FDA Class 2
·Cardiovascular
IQVITALS AND IQVITALS SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
ESTECH COBRA SURGICAL SYSTEM WITH THERMASHIELD ACCESSORY
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 20, 2013
GREENLIGHT ADDSTAT
FDA Adverse Event
Malfunction
·AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·July 7, 2011
SYNCHROMED II
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code LKK·September 23, 2008
M2A-MAGNUM PF CUP 56ODX50ID
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·October 15, 2025
M2A-MAGNUM MOD HD SZ 50MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·October 15, 2025
M2A-MAGNUM 42-50 TPR INSRT STD
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·October 15, 2025
SINGLE USE GUIDWIRE
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code OCY·January 29, 2020
SINGLE USE GUIDWIRE
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code OCY·January 24, 2020
SINGLE USE GUIDWIRE
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code OCY·January 24, 2020
SINGLE USE GUIDWIRE
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code OCY·January 24, 2020
UNKNOWN
FDA Adverse Event
Malfunction
·COOK INC·Product code MIH·October 18, 2019
ROSA Brain 3.0 Application-Brain
FDA Enforcement
Class II
·Terminated·MEDTECH SAS·February 19, 2020
AquaC UNO H [120V, 60Hz, 1000VA, Fresenius US-Version: 24-10VA-1 Vivonic Part Number: G02000970-US
FDA Enforcement
Class II
·Ongoing·Fresenius Medical Care Holdings, Inc.·August 3, 2022