15 results
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28ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SPORVIEW PLUS BI TEST PACK
FDA 510(k)
FDA Class 2
·General Hospital
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613017798·K-Wire, Double Ended, Trocar Point, Diameter 0....
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613017781·K-Wire, Double Ended, Trocar Point, Diameter Si...
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319704950·Bozeman Uterine Dressing Forceps, 10-1/4" (25.6...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197056458·White Tonsil Seizing Forceps
235mm,...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197056427·White Tonsil Seizing Forceps
180mm,...
PREMIER C. DIFFICILE GDH
FDA 510(k)
FDA Class 1
·Microbiology
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR , MODEL KN-550
FDA 510(k)
FDA Class 2
·Cardiovascular
ZEPHYR XL DR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI·Product code DXY·January 13, 2014
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTN·May 31, 2013
SD/PD MEDIUM CURVED
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code ERL·June 17, 2011
MICRUSFRAME18 7MM X 14.3CM
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code KRD·June 29, 2022
KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Size 5 / Adult Silicone King LAD¿ Patient Size: >70kg Product Usage: Laryngeal airway
FDA Enforcement
Class II
·Terminated·King Systems Corp.·November 28, 2012
MICRUSFRAME10 7MM X 30CM
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code KRD·June 29, 2022
Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021