33 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SMR 140° Reverse Humeral Body
FDA 510(k)
FDA Class 2
·Orthopedic
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772344130·PROTECT.PRO ACTION BACK SUPPORT BLACK XL
NA
FDA UDI
Stryker GmbH·07613154639694·Screw Marker 19,5
18M - Loggers - 18 Metal
FDA UDI
Certified Safety Manufacturing, Inc.·00766588015057·18M - Loggers - 18 Metal
Blade Handle
FDA UDI
KATENA PRODUCTS, INC.·00841668112380·BARD-PARKER HANDLE #3
CLASSIC NMS
FDA 510(k)
FDA Class 2
·Physical Medicine
HealthMammo
FDA 510(k)
FDA Class 2
·Radiology
WAL-MART/EQUATE
FDA Adverse Event
Other
·ASO LLC·Product code KGX·August 27, 2013
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·April 18, 2016
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·February 3, 2016
POUNCE VENOUS THROMBECTOMY SYSTEM
FDA Adverse Event
Injury
·SURMODICS INC·Product code QEW·May 16, 2024
HOMECHOICE INTEGRATED APD SET WITH CASSETTE 3- PRONG
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FKX·October 21, 2008
MAXIMO DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code LWS·August 11, 2011
VERSA-DIAL/COMP TI STD TAPER
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code MBF·July 2, 2013
Cepheid Respiratory Control Panel Catalog #8199 for in vitro diagnostic use
FDA Enforcement
Class II
·Terminated·Microbiologics Inc·March 13, 2019
CD117, c-kit (YR145) 1.0 ml catalog number 117R-16 7.0 ml catalog number-18 Microbiology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent
FDA Enforcement
Class II
·Terminated·Cell Marque Corporation·June 7, 2017
LeMaitre Vascular Reddick Cholangiogram Catheter (eIFU) REF# e2400-50
FDA Enforcement
Class II
·Terminated·LeMaitre Vascular, Inc.·March 22, 2017
LeMaitre Vascular Reddick Cholangiogram Stiffer Catheter with introducer (eIFU) REF # e2400-53
FDA Enforcement
Class II
·Terminated·LeMaitre Vascular, Inc.·March 22, 2017
LeMaitre Vascular Scoop Tip Cholangiogram Catheter with Introducer (eIFU) REF# e2401-53
FDA Enforcement
Class II
·Terminated·LeMaitre Vascular, Inc.·March 22, 2017
LeMaitre Vascular Reddick Scoop Tip Cholangiogram Catheter with Introducer (eIFU) REF# e2401-51
FDA Enforcement
Class II
·Terminated·LeMaitre Vascular, Inc.·March 22, 2017