14 results
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26ms
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Sources: EU EUDAMED, US FDA
KDA MICRO CHEMICAL ANALYZER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DELTAVEN
FDA UDI
DELTA MED SPA·08032248380059·Safety I.V Catheter in PUR with closed system ,...
MGB Alert Pneumocystis Probe Mix 48rxn,
FDA UDI
Elitechgroup Mdx LLC·03661540950049·MGB Alert® Pneumocystis Probe Mix is an analyte...
Suture Boot
FDA UDI
KOROS U.S.A., INC.·10840199537270·Suture Boot for 8800-80 Retractor
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450178577·
LDR SPINE ROI-A IMPLANT
FDA 510(k)
FDA Class 2
·Orthopedic
E.N.S.I. SYRINGE
FDA 510(k)
FDA Class 2
·General Hospital
APC PLUS ADHESIVE
FDA Adverse Event
Injury
·3M UNITEK·Product code DYW·June 7, 2007
5.0MM FLEXIBLE SHAFT
FDA Adverse Event
Injury
·SYNTHES BETTLACH·Product code HTO·May 10, 2016
ATS 3000 TOURNIQUET
FDA Adverse Event
Malfunction
·ZIMMER SURGICAL·Product code GFD·February 11, 2014
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 22, 2012
M-1 COT
FDA Adverse Event
Malfunction
·STRYKER CORP MEDICAL DIVISION·Product code FPO·August 3, 2010
Radial Artery Pressure Monitoring Catheter Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Product catalog numbers with heparin coating are designated by the suffix BH.
FDA Enforcement
Class I
·Terminated·Cook Inc.·March 2, 2016
Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021