12 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
MINIHIP STEM
FDA 510(k)
FDA Class 2
·Orthopedic
Cook
FDA UDI
COOK INCORPORATED·00827002167407·Cook Cystostomy Catheter Set
P.L.U.S. SYSTEM (PIVOT LINK UNIVERSAL SYSTEM)
FDA 510(k)
FDA Class 2
·Orthopedic
CONTROL PLASMA P
FDA 510(k)
FDA Class 2
·Hematology
ELECTROSURGICAL COAGULATION FOR AESTHETIC
FDA Adverse Event
Injury
·F CARE SYSTEMS USA LLC·Product code ONQ·November 22, 2013
TURBO-JECT® DOUBLE LUMEN OVER-THE-WIRE POWER-INJECTABLE PICC
FDA Adverse Event
Injury
·COOK INC·Product code LJS·December 20, 2018
3000 ELECTRIC - 78"
FDA Adverse Event
Death
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·April 29, 2013
LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC.·Product code MKJ·April 13, 2011
COLLEAGUE CX TRIPLE CHANNEL VOLUMETRIC INFUISON PUMP
FDA Adverse Event
Injury
·BAXTER HEALTHCARE PTE. LTD·Product code FRN·July 28, 2008
BARD EP XT Decapolar Steerable, Product Number 201007; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·April 30, 2014
Fortify, Sterile EO, Model #/ Part #: CD1231-40/100029238,100030095, 100041981; CD1231-40Q/100029229, 100030087, 100041982; CD1233-40/100029230, 100029250, 100029259,100031058, 100059778, 100070017; CD1233-40Q/100029260, 100029271, 100029277, 100031104, 100070089; CD1235-40/100029272, 100029282, 100029311, 100031039, 100059779; CD1235-40Q/100029273, 100029295, 100029312, 100030840; CD1241-40/100046351; CD1241-40Q/100046167; CD2231-40/100029274, 100030110, 100041922; CD2231-40Q/100029275, 100030089, 100041923; CD2233-40/100029147, 100029276, 100029313, 100031066, 100037043, 100048759, 100070007; CD2233-40Q/100029148, 100029263, 100029314, 100031067, 100037044, 100059770, 100070068; CD2235-40/100029149, 100029265, 100029283, 100031029, 100059837; CD2235-40Q/100029239, 100029258, 100029284, 100031030, 100066504; CD2241-40/100046148; CD2241-40Q/100046149; CD2299-40/100056952
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018