16 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Halo Single-Loop Microsnare Kit
FDA 510(k)
FDA Class 2
·Cardiovascular
LANDANGER
FDA UDI
LANDANGER·03661219343738·
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·00636257156179·TG PRO TACO XS-S STRAP
TAPERLOC POROUS FEMORAL STEM & HA TAPERLOC POROUS LATERALIZED FEMORAL STEM
FDA 510(k)
FDA Class 2
·Orthopedic
DA VINCHI EEG AND EMG/EP SYSTEMS
FDA 510(k)
FDA Class 2
·Neurology
COLLEAGUE VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·October 20, 2008
AMPLATZ SUPER STIFF GUIDEWIRE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - COSTA RICA·Product code DQX·August 11, 2011
XIA 3 TITANIUM TORQUE WRENCH
FDA Adverse Event
Malfunction
·STRYKER SPINE-FRANCE·Product code LXH·July 2, 2013
UNK - ELASTIC NAILS: TITANIUM
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code JDS·May 4, 2021
UNK - ELASTIC NAILS: TITANIUM
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code JDS·May 4, 2021
UNK - ELASTIC NAILS: TITANIUM
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code JDS·May 4, 2021
UNK - END CAPS: TEN
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code KTT·May 4, 2021
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·November 1, 2013
Toshiba Infinix-i X-Ray System. A radiographic and fluoroscopic x-ray system for use in diagnostic and angiographic procedures.
FDA Enforcement
Class II
·Terminated·Toshiba American Medical Systems Inc·April 3, 2013
Spacelabs Healthcare CardioCall ECG Event Recorder, Models VS20, VS20x4, ST80, ST80x4, PCBAs PN # 670-1670-00 Product Usage: The CardioCall event recorder is worn by the patient to record a short period of electrocardiogram which can be sent to his physician.
FDA Enforcement
Class II
·Terminated·Spacelabs Healthcare Inc·November 4, 2015
CytoVision Image Analysis and Capture System, an automated cell-locating device. The Cytovision is a rapid metaphase finder, image acquisition and computer aided chromosome analysis system which assists the operator in viewing chromosomes and looking for cellular anomalies. CytoVision enables a qualified Cytogeneticist to rapidly and accurately analyze the chromosome banding pattern.
FDA Enforcement
Class III
·Terminated·Leica Biosystems Richmond Inc.·June 29, 2016