19 results
·
23ms
·
Sources: EU EUDAMED, US FDA
MODIFICATION TO FEMOSTOP FEMORAL COMPRESSION SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
Cook
FDA UDI
COOK INCORPORATED·00827002142343·Percutaneous Nephrostomy Catheter
LOCATOR F-Tx
FDA UDI
Zest Anchors, LLC·00840481121630·LOCATOR F-Tx Abutment for 4.3mm CAMLOG Connecti...
ITOTAL OVAL PATELLA TRIAL 44MM
FDA UDI
Conformis, Inc.·00810933030452·
LOCATOR R-Tx
FDA UDI
Zest Anchors, LLC·00840481111020·LOCATOR R-Tx Abutment for 4.3mm Camlog Connecti...
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810014605067·BERCHTOLD OPERON D850, D750 3.25" SOFTCARE PLUS
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450180389·
Specials
FDA UDI
Seaspine Orthopedics Corporation·10889981291327·ALIF Shaver, 6mm / 10mm
QUICK COMBO PAD
FDA Adverse Event
Injury
·PHYSIO CONTROL CORP.·Product code MLN·January 17, 1997
DIMENSION ENZYMATIC CARBONATE (ECO2) FLEX METHOD, CATALOG DF137
FDA 510(k)
FDA Class 2
·Clinical Chemistry
PALS NEONATAL PEDIATRIC ECG ELECTRODE, MODELS PN100, PN200
FDA 510(k)
FDA Class 2
·Cardiovascular
ADVANCED MEMBRANE GAS EXCHANGE PMP STERILE
FDA Adverse Event
Malfunction
·EUROSETS S.R.L.·Product code DTZ·September 18, 2020
RIATA ST ACTIVE FIXATION
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·April 26, 2013
EON RECHARGEABLE IPG
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL - NEUROMODULATION DIVISION·Product code LGW·April 7, 2011
CRYSTALENS
FDA Adverse Event
Injury
·EYEONICS, INC.·Product code HQL·July 22, 2008
CONMED
FDA Adverse Event
Malfunction
·CONMED ELECTROSURGERY·Product code GEI·September 15, 2008
Locator-Wand Cover that is sold in a shelf carton (unit packaging) separate to the sterile tray containing and identified as PORT-A-CATH P.A.S. PORT T2 Fluoro-Free, Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm O.D. tray. REF 21-4672-24. Contents: Portal with ULTRA-LOCK Connector, Radiopaque PolyFlow Polyurethane Catheter 5.8Fr with CATH-FINDER Sensor Wire, Locator-Wand cover, Luer Cap, 20G PORT-A-CATH needle, 18G Blunt Needle, Vein Pick, Point-Lok Sharps Safety Device, Product Information. EtO Sterilized. Single Use. Deltec, Inc., St. Paul, MN 55112 U.S.A.
FDA Recall
Terminated
·Smiths Medical MD, Inc.·Product code MMP·March 29, 2006
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