589 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MONOTUBE CARBON TUBE
FDA 510(k)
FDA Class 2
·Orthopedic
PRINCETON
FDA UDI
Princeton Medical Group, Inc.·00810158219519·RETRACTOR PERKINS 3 PRONG LEFT X SERRATED RIGHT...
ELMED
FDA UDI
ELMED INCORPORATED·00842180167162·Perkins otologic retractor, Made right and left...
PENTAX Medical ED34-i10T, Video Duodenoscope
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ALTRA FX HIP SYSTEM
FDA 510(k)
FDA Class 3
·Orthopedic
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·February 15, 2013
ENDOTAK DSP
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code LWS·July 29, 2014
AUTOMATED PD SET W/CASSETTE4 PRONG
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·January 19, 2011
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDT·November 7, 2021
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDT·November 21, 2021
Stryker PCA 10 Degree Hooded Acetabular Insert ID 22mm, Part of the Howmedica PCA Total Hip System intended for use during total hip arthroplasty. The acetabular insert is used in conjunction with PCA Acetabular Shells and Femoral Heads to restore hip joint biomechanics.
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·November 25, 2015
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDT·October 13, 2021
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDT·February 24, 2022
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDT·December 2, 2021
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDT·April 7, 2022
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDF·December 1, 2021
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDT·December 1, 2021
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDT·December 23, 2022
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDT·January 19, 2022
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDT·January 19, 2022