17 results
·
20ms
·
Sources: EU EUDAMED, US FDA
SUNMED FOLEY CATHETERS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Universal Precision Composite Instrument #2 (UPC2)
FDA UDI
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.·07540172012799·Dental restorative material applicator
Symmetry Surgical®
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482130186·Symmetry® Forceps, Adson Tissue, 4 3/4 in
Symmetry Adson
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482048672·Symmetry® Forceps, Adson Tissue, 1x2 Teeth, 4 3...
Rumor
FDA UDI
Ortho Organizers, Inc.·00190707004286·Rumor .018 LR3 -6T 3A 0O
Rumor
FDA UDI
Ortho Organizers, Inc.·00190707004293·Rumor .018 LR3 HK -6T 3A 0O
RANDOX DIGITOXIN
FDA 510(k)
FDA Class 2
·Clinical Toxicology
RUBBERCARE POLYMER-CHLORINATED POWDER-FREE GUARDIAN POLYMER-CHLORINATED POWDER-FREE
FDA 510(k)
FDA Class 1
·General Hospital
HNM MEDICAL
FDA UDI
HNM STAINLESS, LLC.·00842962162811·ADSON TISSUE FORCEPS, 4 3/4", 1x2 TEETH
INTERSTIM II
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·May 24, 2017
INTERSTIM II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code EZW·August 28, 2012
ISPAN PERFLUOROPROPANE (C3F8) GAS
FDA Adverse Event
Injury
·ALCON - FORT WORTH / ALCON LABORATORIES, INC.·Product code LPO·July 14, 2011
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·INVAMEX·Product code IOR·April 16, 2013
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·September 4, 2014
SYNCHROMED
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LKK·June 18, 2008
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015
Ellipse, Sterile EO, Model #/ Part #: CD1275-36/100116115; CD1275-36Q/100116116; CD1277-36/100048388, 100048391, 100060126, 100116208, 10011636; CD1277-36Q/100048374, 100048394, 100060198, 100098497, 100116268, 100116345; CD1293-36Q/100057838; CD1309-36/100057717; CD1309-36Q/100057718; CD1311-36/100057802, 100060153; CD1311-36Q/100057803, 100060174, 100116264; CD1377-36/100078796, 100079180, 100096847; CD1377-36C/100078612, 100079197, 100079368, 100116120, 100116407, 100116447; CD1377-36Q/100078747, 100079210, 100096848, 100116385, 100116423, 100116427; CD1377-36QC/100078602, 100079199, 100079229, 100116398, 100116409, 100116466,100116485, 100127151, 100127152, 100127153; CD1393-36C/100116461; CD1393-36QC/100080656, 100116339; CD1409-36Q/100080251; CD1411-36C/100080197, 100080232, 100116411, 100116481; CD1411-36Q/100080244, 100080245, 100116338, 100116464; CD1411-36QC/100116337; CD2275-36/100116355; CD2275-36Q/100116349; CD2277-36/100048359, 100048402, 100116206, 100116207; CD2277-36Q/100048377, 100048404,100060190, 100098661, 100116342, 100116350; CD2293-36/100057765; CD2293-36Q/100057766; CD2309-36/100057804; CD2309-36Q/100057763; CD2311-36/100057679, 100060100; CD2311-36Q/100057835, 100060161, 100116351; CD2377-36/100078811, 100079226, 100096774; CD2377-36C/100078601,100079225, 100079304, 100116405, 100116424, 100116484; CD2377-36Q/100078812,100079208, 100096838, 100116406, 100116414, 100116437; CD2377-36QC/100078579, 100079176, 100079352, 100116413, 100116422, 100116436, 100116482, 100127100, 100127154, 100127181; CD2393-36C/100080653, 100116416; CD2393-36QC/100080655, 100116451; CD2409-36C/100079997; CD2409-36Q/100080149; CD2411-36C/100079986, 100080104, 100116118, 100116444; CD2411-36Q/100080180, 100080230, 100116370, 100116420
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018