16 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VASHE WOUND SOLUTION (4.0 OZ), (8.5 OZ & (16.0 OZ)
FDA 510(k)
FDA Unclassified
·Unknown
Oticon
FDA UDI
Oticon A/S·05707131258984·NERA PRO, KIT 312 WL DIR L V BE
Ophthalmic Spatula
FDA UDI
KATENA PRODUCTS, INC.·00841668102251·SLOANE LASEK MICRO HOE AND EPI PEEL, D-E
EXETER X3 RIMFIT ACETABULAR CUP
FDA 510(k)
FDA Class 2
·Orthopedic
SAPPHIRE ANTERIOR CERVICAL PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
BINAXNOW COVID-19 AG CARD
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·February 18, 2021
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·October 1, 2014
REVOLUTION CMS W/BREAKAWAY
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-PUERTO RICO·Product code JDZ·May 29, 2013
CARELINK
FDA Adverse Event
Injury
·MEDTRONIC MILACA INC.·Product code DXY·June 16, 2011
ROD, FIXATION, INTRAMEDULLARY
FDA Adverse Event
Injury
·SYNTHES USA·Product code HSB·May 4, 2016
ROD, FIXATION, INTRAMEDULLARY
FDA Adverse Event
Injury
·SYNTHES USA·Product code HSB·May 4, 2016
ROD, FIXATION, INTRAMEDULLARY
FDA Adverse Event
Injury
·SYNTHES USA·Product code HSB·May 4, 2016
R3 XLPE INSERT
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JDI·May 25, 2025
TFNA FEM NAIL Ø11 R 130° L360 TIMO15
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code HSB·February 23, 2023
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HWC·April 5, 2018
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015