32 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EsoCheck Cell Collection Device
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
SORBIE QUESTOR
FDA UDI
WRIGHT MEDICAL TECHNOLOGY, INC.·00889797060752·Elbow Sawblade
SOFTSILK
FDA UDI
Smith & Nephew, Inc.·03596010510754·9 X 20 MM SOFTSILK 1.5 SCREW
...
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319706411·Lahey Skin Hook 4-3/4" (11.9cm), 1 sharp single...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197118569·Lambotte mini osteotome, curved
12mm, ...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197118484·Lambotte mini osteotome, curved
4 mm, ...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197118460·Lambotte mini osteotome, curved
2 mm, ...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197118521·Lambotte mini osteotome, curved
8 mm, ...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197118545·Lambotte mini osteotome, curved
10 mm,...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197118507·Lambotte mini osteotome, curved
6 mm, ...
ABX PENTRA ENZYMATIC CREATININE CP, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, ABX PENTRA P CONTROL, AND ABX PENTRA URIN
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ORBITER II CCI/SPECT ORBITER II CCI/SPECT
FDA 510(k)
FDA Class 2
·Radiology
LUNDERQUIST SUPPORT WIRE GUIDE
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code DQX·May 13, 2026
HARMONIC ACE 36 CM
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC·Product code LFL·October 20, 2008
FREEDOM SELF-CATH NELATON CH14
FDA Adverse Event
Malfunction
·COLOPLAST A/S·Product code KOD·August 12, 2011
EASYTRAK 2
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code OJX·July 8, 2013
LUNDERQUIST EXTRA-STIFF DOUBLE CURVED EXCHANGE SUPPORT WIRE GUIDE
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code DQX·May 11, 2026
LUNDERQUIST EXTRA-STIFF STRAIGHT EXCHANGE SUPPORT WIRE GUIDE
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code DQX·March 20, 2026
AQUAPAK SW/EAU STERILE, 340 ML W/ADAPTOR Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor packaged with the water bottle is affected by this recall.
FDA Enforcement
Class II
·Terminated·Teleflex Medical·February 18, 2015
LUNDERQUIST EXTRA-STIFF CURVED EXCHANGE SUPPORT WIRE GUIDE
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code DQX·February 26, 2024