17 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SAGIPLAN, SAGIPLAN PROSTATE MODULE ADD ON, SAGIPLAN INCLUDING PROSTATE MODULE
FDA 510(k)
FDA Class 2
·Radiology
Argyle
FDA UDI
Cardinal Health 200, LLC·10192253041767·Arygle Suction Catheter with Directional Valve ...
Biomet® Knee System
FDA UDI
Biomet Orthopedics, LLC·00880304459922·
Argyle
FDA UDI
Cardinal Health, Inc.·10884527002566·Suction Catheter with Directional Valve,Straigh...
ZEOS
FDA UDI
SANTA BARBARA IMAGING SYSTEMS, INC.·00812231031223·ARTHROSCOPE, 1.9MM 0DEG
HAKKI URINARY CATHETER; SIZE 14, 16, 18, 20, 22, 24, 26 FRENCH
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
HC604 CPAP HUMIDIFIER
FDA 510(k)
FDA Class 2
·Anesthesiology
PRECISION MONTAGE MRI
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·December 17, 2020
ALARIS PUMP MODULE
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·April 29, 2021
NBCS (NATIONAL BIOMEDICAL COMPUTER SYSTEM)
FDA Adverse Event
Malfunction
·AMERICAN NATIONAL RED CROSS·Product code MMH·March 29, 2000
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·October 4, 2014
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 3, 2013
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·June 28, 2011
TOTAL KNEE REPLACEMENT
FDA Adverse Event
Malfunction
·STANMORE IMPLANTS WORLDWIDE LTD·Product code KRO·November 10, 2016
PATIENT SPECIFIC TOTAL FEMUR
FDA Adverse Event
Injury
·STANMORE IMPLANTS WORLDWIDE·Product code KRO·August 15, 2018
iCup DX 6 Panel w/Adulterant, Item No. I-DXA-167-013
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 15 X 155 MM, Silicone, Sterile, Item 431193.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020