54 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SPECIAL ORTHOPAEDIC SOLUTIONS GLENOID SHOULDER COMPONENT
FDA 510(k)
FDA Class 2
·Orthopedic
Altus Spine Cervical Interbody Fusion System
FDA UDI
Altus Spine, LLC·00843210131184·Rasp, W/Tab
PMT CORPORATION - STEREOTACTIC
FDA UDI
PMT CORPORATION·00650551038719·SILICONE STOPPERS WITH SLIT, FOR DEPTHALON
NA
FDA UDI
Stryker Leibinger GmbH & Co. KG·34546540134739·LIGATURE WIRES
LARGE PLATE/WIRE CUTTER
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896051454·LARGE PLATE/WIRE CUTTER
SIMPLICITY QD SOFT INFUSION SET FOR USE BY PEOPLE WITH DIABETES IN INFUSE INSULIN SUBCUTANEOUSLY FROM A PUMP OR SYRINGE
FDA 510(k)
FDA Class 2
·General Hospital
BACT/ALERT CSR
FDA 510(k)
FDA Class 1
·Microbiology
LL 100, 103, 104 DIAGNOSTIC LAPAROSCOPE RIGID ROD LENS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
EVA, COMBINED MACHINE INCLUDING LASER (DORC CONNECTOR)
FDA Adverse Event
Malfunction
·DUTCH OPTHALMIC RESEARCH CENTER BV·Product code HQC·June 25, 2018
BIPAP A40
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code MNT·December 4, 2023
GEN MODEL UNK
FDA Adverse Event
Malfunction
·CYBERONICS INC·Product code LYJ·June 29, 2011
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·December 1, 2022
BIPAP A40
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code MNT·December 4, 2023
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·December 20, 2022
BIPAP A40
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code MNT·December 4, 2023
ARCHITECT C8000 SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT MANUFACTURING, INC.·Product code JJE·February 8, 2008
LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 62/28
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·January 12, 2022
VNS Therapy Programmer, Model 3000, v1.0 System
FDA Recall
Terminated
·Cyberonics, Inc·Product code MUZ·November 13, 2017
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·February 16, 2021
SYNCHROMED II
FDA Adverse Event
Injury
·NEUROLOGICAL DIVISION, MEDTRONIC, INC·Product code LKK·November 4, 2005