17 results
·
31ms
·
Sources: EU EUDAMED, US FDA
MODEL RS 8300
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ERA® Implant Abutment Standard 0°, 2mm Cuff (BF)
FDA UDI
STERNGOLD DENTAL LLC·00841549103117·Implant retained overdentures are an establishe...
LMDental
FDA UDI
LM-Dental·06438311220703·LM-LiftOut S3, Extraction
Perfect Fit
FDA UDI
DYMEDIX DIAGNOSTICS, INC.·00817377021534·Cadwell ApneaTrak Pediatric Effort Belt Kit: 2 ...
Multi Modality Viewer
FDA 510(k)
FDA Class 2
·Radiology
PHEM-ALERT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
28MM M2A HI CARBON HD STD NK
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·May 15, 2014
SPRINT QUATTRO SECURE
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·October 31, 2012
PUMP MMT-522NAH PRDGM INS V2.4 PK
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code LZG·August 20, 2010
OSS LOCKING PIN
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·December 5, 2017
OSS RS AXLE
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KRO·December 6, 2017
OSS RS FEMORAL BUSHING
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KRO·December 5, 2017
OSS RS SEGENTAL FEMORAL
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KRO·December 5, 2017
OSS TM YOKE
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·December 5, 2017
OSS DCM POLYETHYLENE TIBIAL BEARING
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·December 5, 2017
OSS TIBIAL BUSHING
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·December 5, 2017
Fortify, Sterile EO, Model #/ Part #: CD1231-40/100029238,100030095, 100041981; CD1231-40Q/100029229, 100030087, 100041982; CD1233-40/100029230, 100029250, 100029259,100031058, 100059778, 100070017; CD1233-40Q/100029260, 100029271, 100029277, 100031104, 100070089; CD1235-40/100029272, 100029282, 100029311, 100031039, 100059779; CD1235-40Q/100029273, 100029295, 100029312, 100030840; CD1241-40/100046351; CD1241-40Q/100046167; CD2231-40/100029274, 100030110, 100041922; CD2231-40Q/100029275, 100030089, 100041923; CD2233-40/100029147, 100029276, 100029313, 100031066, 100037043, 100048759, 100070007; CD2233-40Q/100029148, 100029263, 100029314, 100031067, 100037044, 100059770, 100070068; CD2235-40/100029149, 100029265, 100029283, 100031029, 100059837; CD2235-40Q/100029239, 100029258, 100029284, 100031030, 100066504; CD2241-40/100046148; CD2241-40Q/100046149; CD2299-40/100056952
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018