12 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
SafeSource Direct Blue Powder-Free Nitrile Exam Gloves
FDA 510(k)
FDA Class 1
·General Hospital
Pressure Sentinel® Intramedullary Reaming System
FDA UDI
Zimmer, Inc.·00889024039216·
Pressure Sentinel® Intramedullary Reaming System
FDA UDI
Zimmer, Inc.·00889024039223·
PRECISION
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·May 26, 2021
PTS PANELS LIPID PANEL TEST STRIPS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
FLOWART NEEDLE-FREE SPLIT SEPTUM VALVE
FDA Adverse Event
Malfunction
·ASSET MEDIKAL TASARIM SAN. TIC. A.S.·Product code FPA·July 24, 2025
SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA
FDA Adverse Event
Malfunction
·STAAR SURGICAL CO.·Product code HQL·November 6, 2008
SM104 MSERIES W5TH WHL
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·July 15, 2011
LOCKING SCREW Ø5 SELF-TAP L38 TAN
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code KTT·July 12, 2013
SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels
FDA Enforcement
Class I
·Terminated·Zimmer Biomet, Inc.·November 7, 2018
Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018