14 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CARDIOBLATE 68000 GNERATOR, BP2 SURGICAL ABLATION DEVICE, LP SURGICAL ABLATION DEVICE, GEMINI-SSURGICAL ABLATION DEVICE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
iTotal® Patella Trial
FDA UDI
Conformis, Inc.·00850268007088·iTotal® 29mm Patella Trial Reusable Instrument
Symmetry Rhoton®
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482140833·Rhoton Forceps; Bayonet Bipolar; Titanium; 1.5 ...
HARDYDISK, VANCOMYCIN 30MCG
FDA 510(k)
FDA Class 2
·Microbiology
CEDARS-SINAI BPGS AND MOCO
FDA 510(k)
FDA Class 2
·Radiology
DAILY ACTIVITY ASSIST DEVICES
FDA Adverse Event
KENSTONE METAL·Product code IKX·April 26, 2013
LIGHTSPEED VCT
FDA Adverse Event
Injury
·GE MEDICAL SYSTEMS, LLC·Product code JAK·April 22, 2011
GORE EXCLUDER AAA ENDOPROTHESIS
FDA Adverse Event
Injury
·W. L. GORE & ASSOCIATES, INC.·Product code MIH·July 22, 2008
SMALL SUPERIOR AUGMENT GLENOID PLATE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWS·February 22, 2024
PALINDROME EMERALD SPORT PACK Cuffed Dual Lumen Catheter with Pre-curved Shaft and Heparin Coating, REF 8888123411, Size 14.5Fr/Ch (4.85mm) x 23cm. TYCO HEALTHCARE GROUP LP, Mansfield, MA 02048. --- NOTE: Both the "sport pack" and "kit" package configurations include the catheter, Venetrac insertion stylets, pull apart sheath, and other accessories necessary for placement. The Venetrac insertion stylet is an optional accessory. The 510k for the Venetrac accessory is K051584. The 510k for the catheter is K060509.
FDA Recall
Terminated
·Covidien·Product code NYU·September 19, 2008
PALINDROME EMERALD SPORT PACK Cuffed Dual Lumen Catheter with Pre-curved Shaft and Heparin Coating, REF 8888128461, Size 14.5Fr/Ch (4.85mm) x 28cm. TYCO HEALTHCARE GROUP LP, Mansfield, MA 02048. --- NOTE: Both the "sport pack" and "kit" package configurations include the catheter, Venetrac insertion stylets, pull apart sheath, and other accessories necessary for placement. The Venetrac insertion stylet is an optional accessory. The 510k for the Venetrac accessory is K051584. The 510k for the catheter is K060509.
FDA Recall
Terminated
·Covidien·Product code NYU·September 19, 2008
PALINDROME EMERALD Kit - Cuffed Dual Lumen Catheter with Pre-cuffed Shaft and Heparin Coating, REF 8888145070, 14.5 FR/CH (4.85mm) x 28 cm. TYCO HEALTHCARE GROUP LP, Mansfield, MA 02048. --- NOTE: Both the "sport pack" and "kit" package configurations include the catheter, Venetrac insertion stylets, pull apart sheath, and other accessories necessary for placement. The kit includes additional components that would also be available at the hospital, such as a scalpel, wound dressing, etc. The Venetrac insertion stylet is an optional accessory. The 510k for the Venetrac accessory is K051584. The 510k for the catheter is K060509.
FDA Recall
Terminated
·Covidien·Product code NYU·September 19, 2008
PALINDROME EMERALD Kit - Cuffed Dual Lumen Catheter with Pre-curved Shaft and Heparin Coating, REF 8888145069, 14.5 Fr/CH (4.85mm) x 23cm. TYCO HEALTHCARE GROUP LP, Mansfield, MA 02048. --- NOTE: Both the "sport pack" and "kit" package configurations include the catheter, Venetrac insertion stylets, pull apart sheath, and other accessories necessary for placement. The kit includes additional components that would also be available at the hospital, such as a scalpel, wound dressing, etc. The Venetrac insertion stylet is an optional accessory. The 510k for the Venetrac accessory is K051584. The 510k for the catheter is K060509.
FDA Recall
Terminated
·Covidien·Product code NYU·September 19, 2008
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