19 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SAVIEW-AQUA 58 UV (ETAFILCON A) VISIBILITY TINTED SOFT (HYDROPHILIC) CONTACT LENS, SAVIEW-AQUA 58 UV TORIC (ETAFILCON A)
FDA 510(k)
FDA Class 2
·Ophthalmic
NexxZr™ T / D-100-14-NT-D200-SD
FDA UDI
SAGEMAX BIOCERAMICS, INC·00842271113566·
PVS 1300 SYNCHRO 0.014 & PVS 1600 SYNCHRO 0.010 GUIDE WIRES
FDA 510(k)
FDA Class 2
·Cardiovascular
BAHADIR STERILIZATION TRAYS
FDA 510(k)
FDA Class 2
·General Hospital
ALINITY C PROCESSING MODULE
FDA Adverse Event
Malfunction
·ABBOTT LABORATORIES·Product code JJE·December 16, 2024
OT VERIO2 METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·December 13, 2017
ALINITY C PROCESSING MODULE
FDA Adverse Event
Malfunction
·ABBOTT LABORATORIES·Product code JJE·August 11, 2022
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 29, 2013
SCULPTRA
FDA Adverse Event
Injury
·SANOFIAVENTIS U.S. LLC·Product code LMH·June 15, 2011
ACUITY
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code OJX·October 1, 2014
SYNCHRO GUIDEWIRE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - SALT LAKE CITY·Product code DQX·April 8, 2010
SYNCHRO GUIDEWIRE
FDA Adverse Event
Death
·BOSTON SCIENTIFIC - SALT LAKE CITY·Product code DQX·August 2, 2010
SYNCHRO GUIDEWIRE
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - SALT LAKE CITY·Product code DQX·May 27, 2010
SYNCHRO GUIDEWIRE
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - SALT LAKE CITY·Product code DQX·April 15, 2010
SYNCHRO-14 STRAIGHT 200-35CM
FDA Adverse Event
Malfunction
·STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY·Product code DQX·December 12, 2023
SYNCHRO-10 STRAIGHT 200CM
FDA Adverse Event
Malfunction
·STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY·Product code DQX·October 13, 2023
SYNCHRO-14 STRAIGHT 200-35CM
FDA Adverse Event
Malfunction
·STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY·Product code DQX·November 13, 2023
POLYMETHYLMETHACRYLATE BONE CEMENT
FDA Adverse Event
Injury
·SYNTHES SELZACH·Product code NDN·August 16, 2016
Lockheed Martin Gyrocam Systems ( LMGS) LMGS 15" camera systems. Laser pointer and illuminator used for law enforcement surveillance from aircraft. Models DNV, TS and DS
FDA Enforcement
Class II
·Terminated·Lockheed Martin Gyrocam Systems, Inc.·February 20, 2013