312 results
·
23ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
VisCalor
FDA 510(k)
FDA Class 2
·Dental
AGXO
FDA UDI
Oticon A/S·05707131352231·G500 S, MINIRITE 312 2.4G C091 AGXO
OptoMonitor 3
FDA UDI
Opsens Inc·07540184013074·
Ophthlamic Speculum
FDA UDI
KATENA PRODUCTS, INC.·10841668115159·BARRAQUER SPECULUM Disposable with Finger tabs ...
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668113820·VISCO CANNULA 25GA ANGLE 8MM
CONTINUUM KNEE SYSTEM-PS FEMORAL COMPONENTS- POROUS, MODEL XX-YYY-ZZZZZ
FDA 510(k)
FDA Class 2
·Orthopedic
BLOOD GLUCOSE MONITORING SYSTEM, MODELS AG-6081 AND AG-6951
FDA 510(k)
FDA Class 2
·Clinical Chemistry
3.5FR P.U.R. UMBIL CATH X10
FDA Adverse Event
Malfunction
·COVIDIEN·Product code FOS·July 12, 2013
ROUND BLAKE HUBLESS SILICON DRAINS - 3/4 FLUTED
FDA Adverse Event
Injury
·ETHICON INC.·Product code KOG·April 7, 2014
MOUNTAINEER HEAD TO HEAD CROSS CONNECTOR INNER SCREW
FDA Adverse Event
Malfunction
·DEPUY SYNTHES SPINE·Product code KWP·March 13, 2014
I-STAT CHEM8+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code JGS·August 30, 2013
epoc BGEM Test Card (Catalogue number CT-1004-00-00). quantitative testing of samples for pH, pCO2, pO2, Sodium Potassium , Ionized Calcium, Glucose, Lactate and Hematocrit.
FDA Enforcement
Class II
·Terminated·Epocal·August 21, 2013
MEDIUM SPECIMEN RETRIEVAL BAG, 100MMX150
FDA Adverse Event
Malfunction
·GENICON·Product code FMH·April 21, 2015
HEARTSTREAM FR2
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 26, 2013
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·August 3, 2011
OMNIPOD INSULIN PUMP
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code LZG·September 17, 2014
HEART LUNG MACHINE
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY GMBH·Product code DTQ·October 9, 2020
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·April 28, 2023
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·March 12, 2013
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·July 23, 2013