19 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MODIFICATON TO: PYRAMID +4 ANTERIOR LUMBAR PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ACCUTNI AND ACCUTNI CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEM # 33340, 33345
FDA 510(k)
FDA Class 2
·Clinical Chemistry
AB BELT PRO
FDA 510(k)
FDA Class 2
·Physical Medicine
AJUST ADJUSTABLE SINGLE INCISION SLING
FDA Adverse Event
Injury
·C.R. BARD, INC. (COVINGTON)·Product code FTL·April 24, 2013
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·May 6, 2011
CERAMTEC CERAMIC INS/SLEEVE TRIDENT E
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS CORK·Product code MRA·July 21, 2008
UNICEL® DXI 600 ACCESS IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code MMI·December 22, 2011
UNICEL® DXI 600 ACCESS IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code MMI·December 22, 2011
UNICEL® DXI 600 ACCESS IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·December 22, 2011
UNICEL® DXI 600 ACCESS IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code MMI·December 22, 2011
UNICEL® DXI 600 ACCESS IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code MMI·December 22, 2011
UNICEL® DXI 600 ACCESS IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code MMI·December 22, 2011
UNICEL® DXI 600 ACCESS IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code MMI·December 22, 2011
UNICEL® DXI 600 ACCESS IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code MMI·December 22, 2011
UNICEL® DXI 600 ACCESS IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code MMI·December 22, 2011
CANN 5.5 WO/HOLES LTX FREE ORANGE
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code NBH·August 10, 2022
CANN 5.5 WO/HOLES LTX FREE ORANGE
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code NBH·August 10, 2022
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·April 30, 2014
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018