39 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Vitalograph Model 2120 In2itive eDiary
FDA 510(k)
FDA Class 2
·Anesthesiology
OsteoMed
FDA UDI
OSTEOMED LLC·00845694007016·Mandible System Autoclave Tray
MIXTER-PAUL FORCEPS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896061149·MIXTER-PAUL FORCEPS RIGHT ANGLED SERRATED TIPS
ELMED
FDA UDI
ELMED INCORPORATED·00842180102828·MONOPOLAR RF-CABLE WITH MALE BANANA (4 MM DIA.)...
MAYO STILLE SCISSORS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896055384·MAYO STILLE SCISSORS STRAIGHT ROUND TUNGSTEN CA...
PTS Roll Stand with Basket
FDA UDI
Delfi Medical Innovations Inc·M995922005501·The PTS Roll Stand is a strong and sturdy mobil...
OTW MEGALINK SDS BILIARY STENT SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PASSPORT 2 WITH VIEW 12 ECG ANALYSIS MODULE MODEL # 0998-00-0170-XXXX
FDA 510(k)
FDA Class 2
·Cardiovascular
BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·March 16, 2021
BD PARADIGM LINK BLOOD GLUCOSE MONITOR
FDA Adverse Event
Other
·BECTON DICKINSON·Product code NBW·November 15, 2004
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
FDA Adverse Event
Injury
·TANDEM DIABETES CARE·Product code OZO·March 31, 2020
D-TRONPLUS
FDA Adverse Event
Malfunction
·DISETRONIC MEDICAL SYSTEMS INC·Product code LZG·March 9, 2005
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
FDA Adverse Event
Injury
·TANDEM DIABETES CARE·Product code OZO·May 1, 2019
XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIQ·October 24, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011
BED, MANUAL
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code FNJ·July 1, 2013
ANIMAS INSULIN CARTRIDGE
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·June 9, 2014
epoc BGEM Test Card 25 Test Cards/box. In vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood Product Siemens SMN#/Model #: 10736515
FDA Enforcement
Class II
·Ongoing·Siemens Healthcare Diagnostics Inc·July 20, 2022
ONYX
FDA Adverse Event
Injury
·MICRO THERAPEUTICS, INC. DBA EV3·Product code MFE·June 20, 2017
NV MICROCATHETER
FDA Adverse Event
Injury
·COVIDIEN (IRVINE)·Product code KRA·April 24, 2017