16 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ELECSYS TROPONIN T
FDA 510(k)
FDA Class 2
·Clinical Chemistry
K-Systems
FDA UDI
RESEARCH INSTRUMENTS LIMITED·05060554120307·Assisted Reproduction Accessories
P.F.C. SIGMA
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295239178·P.F.C. SIGMA TC3 TIBIAL INSERT TRIAL SZ 1.5 10m...
Needle Holder
FDA UDI
KATENA PRODUCTS, INC.·00841668108116·CASTROVIEJO NEEDLE HOLDER STR W/ LOCK
Eye Shield
FDA UDI
KATENA PRODUCTS, INC.·00841668111185·PIN HOLE EYE SHIELD WHITE PACK OF 12
MICROSPAN SYSTEM
FDA Adverse Event
Malfunction
·ETHICON, INC.·Product code FED·June 8, 2006
MEG-TORQ
FDA 510(k)
FDA Class 1
·Dental
SICACE DENTAL IMPLANT SYSTEM AND SIC ANGLED ABUTMENTS
FDA 510(k)
FDA Class 2
·Dental
CLXECP KIT
FDA Adverse Event
Injury
·THERAKOS·Product code LNR·September 16, 2009
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·February 14, 2013
SENSORMEDICS
FDA Adverse Event
Malfunction
·CAREFUSION·Product code LSZ·January 10, 2011
ENDOVIVE? JEJUNAL FEEDING TUBE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - SPENCER·Product code KNT·July 28, 2014
SINGLE FUNCTION ABC PENCIL, HAND CONTROL HANDPIECE
FDA Adverse Event
Malfunction
·CONMED ELECTROSURGERY·Product code HAM·September 11, 2015
GE Healthcare Care Plus Hood Field Replacement Unit (FRU) kit, Part Numbers: 6600-0047-851, 6600-0033-850, 6600-0081-850, 6600-0961-500, 6600-0083-850
FDA Enforcement
Class I
·Ongoing·Wipro GE Healthcare Private Ltd.·February 21, 2024
GE Healthcare Care Plus Hood Field Replacement Unit (FRU) kit, Part Numbers: 6600-0047-851, 6600-0033-850, 6600-0081-850, 6600-0961-500, 6600-0083-850
FDA Recall
Open, Classified
·Wipro GE Healthcare Private Ltd. 122 Part 1 Odyssey And Galileo Bengaluru India·Product code FMZ·December 26, 2023
Philips Zenition 50, Model Number: 718096
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·November 20, 2024