21 results
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19ms
·
Sources: EU EUDAMED, US FDA
BLADDERSCAN BVI 9400 ULTRASOUND
FDA 510(k)
FDA Class 2
·Radiology
Sklar®
FDA UDI
SKLAR CORPORATION·10649111091117·MILLER ENG-STYLE STAND SZ 11/2
INSIDE VIEW
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CLEAR OR BRAIDED CONTRAST MEDIA INJECTION LINE WITH OR WITHOUT ROTATOR, CATH LAB KIT
FDA 510(k)
FDA Class 2
·Cardiovascular
Biliary Plastic Stent Set
FDA UDI
Micro-Tech (Nanjing) Co., Ltd.·06932503514651·TPU,Straight,7Fr,12cm working length with 1700m...
Biliary Plastic Stent Set/ short-wire compatible
FDA UDI
Micro-Tech (Nanjing) Co., Ltd.·06932503514927·TPU,Center bend,7Fr,12cm working length with 17...
Biliary Plastic Stent Set
FDA UDI
Micro-Tech (Nanjing) Co., Ltd.·06932503513999·TPU,Side bend,7Fr,12cm working length with 1700...
Biliary Plastic Stent Set
FDA UDI
Micro-Tech (Nanjing) Co., Ltd.·06932503514231·TPU,Center bend,7Fr,12cm working length with 17...
Biliary Plastic Stent Set/ short-wire compatible
FDA UDI
Micro-Tech (Nanjing) Co., Ltd.·06932503515115·TPU, Double pigtails,7Fr,12cm working length wi...
Biliary Plastic Stent Set
FDA UDI
Micro-Tech (Nanjing) Co., Ltd.·06932503514484·TPU, Double pigtails,7Fr,12cm working length wi...
Biliary Plastic Stent Set/ short-wire compatible
FDA UDI
Micro-Tech (Nanjing) Co., Ltd.·06932503514743·TPU,Side bend,7Fr,12cm working length with 1700...
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 26, 2025
DONJOY FULLFORCE,ACL,SHRT CF,LT,XS
FDA Adverse Event
Injury
·DJO, LLC·Product code ITQ·June 26, 2019
STEALTH 360
FDA Adverse Event
CARDIOVASCULAR SYSTEMS INC.·Product code MCW·April 15, 2013
BARD FLAT MESH
FDA Adverse Event
Injury
·DAVOL INC, SUB C.R. BARD, INC.·Product code FTL·September 2, 2014
CAPSUREFIX NOVUS
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·April 27, 2011
COOK CELECT PLATINUM NAVALIGN FEMORAL VENA CAVA FILTER SET
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code DTK·December 14, 2020
ADVIA CENTAUR XP FOLATE (FOL) ASSAY
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code CGN·January 9, 2014
Visualase Thermal Therapy System, Software: Visualase Software versions 3.1.1 - 3.2, Product #: 9735542
FDA Enforcement
Class II
·Terminated·Medtronic Navigation, Inc.·October 3, 2018
Ultra/Phonic Focus BP Conforming Gel Pads, UDI 00300361301021 (Primary); 10300361301028 (Package) - Product Usage: A gel pad for use on woman s areola during an ultrasound examination. Its primary purpose is for patient comfort over the loose gel and helps with nipple location during the scan, making the areola location easier to identify.
FDA Enforcement
Class II
·Terminated·Pharmaceutical Innovations, Inc.·August 26, 2020