9 results
·
18ms
·
Sources: EU EUDAMED, US FDA
S TEST REAGENT CARTRIDGE BUN AND S TEST REAGENT CARTRIDGE CRE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Oticon
FDA UDI
Oticon A/S·05707131257338·H16, BTE 13 WL 100 TC
Ophthalmic Spatula
FDA UDI
KATENA PRODUCTS, INC.·00841668115145·EIPPERT SPATULA, DOUBLE-EDED
CURAD SILVER ACTIVE GEL BANDAGE
FDA 510(k)
FDA Unclassified
·Unknown
SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
BATTERY OSCILLATOR
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code MOQ·May 29, 2013
RADIESSE DERMAL FILLER
FDA Adverse Event
Other
·MERZ AESTHETICS, INC.·Product code LMH·June 13, 2011
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·October 1, 2014
STERIS SYSTEM 1E Liquid Chemical Sterilant Processing System. Model P6500, 510 (k) Numbers: K090036 Cleared 4/05/2010; K101409 cleared 8/2/2010; K102462, cleared 9/2/2010; add to file 2/24/2011. The SYSTEM 1E Liquid Sterilant Processing System is intended for the liquid chemical sterilization of manually cleaned immersible and reuseable critical and semi-critical heat sensitive medical devices, including endoscopes and their accessories.
FDA Recall
Terminated
·Steris Corporation Hopkins Facility·Product code MED·December 7, 2011