11 results
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27ms
·
Sources: EU EUDAMED, US FDA
ANESTHESIA/RESPIRATORY FACE MASK, VARIOUS SIZES
FDA 510(k)
FDA Class 1
·Anesthesiology
TRU/PUR 2.0mm Pilot Drill 6,8,10,12,14mm
FDA UDI
STERNGOLD DENTAL LLC·00841549114809·A metal device used in dental surgery to create...
IMMULITE® 2000 XPi Sample Nesting Cups
FDA UDI
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD·00630414982403·Test tube, non-sterile
MRT 50A BRAIN QD COIL
FDA 510(k)
FDA Class 2
·Radiology
DAVOL SCOPE IRRIGATION SYSTEM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
BD PLASTIPAK 20 ML SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·July 17, 2019
COLLEAGUE CXE VOLUMETRICINFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·November 22, 2010
TENDRIL SDX
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVN·January 9, 2013
ENDOTAK DSP
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code LWS·July 1, 2014
K-FILE M-ACCESS 25MM 010
FDA Adverse Event
Malfunction
·MAILLEFER INSTRUMENTS HOLDING SARL·Product code EKS·November 12, 2025
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015