12 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LEONARDO SYNGO CARDIOLOGY WORKSTATION
FDA 510(k)
FDA Class 2
·Radiology
JOBST forMen
FDA UDI
BSN MEDICAL, INC.·04042809702033·FOR MEN 15-20 MM HG THIGH MICRO DOT BAND CLOSED...
ABBOTT LIFECARE PCA 3 INFUSER, MODEL 12384
FDA 510(k)
FDA Class 2
·General Hospital
CLAY-PARK LABS, INC. - LUBRICATING JELLY
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
NUMERIS TETHERED COAGULATION SYSTEM WITH VISITRAX
FDA Adverse Event
Death
·ATRICURE, INC.·Product code OCL·November 13, 2018
MINIARC PRECISE SLING SYSTEM
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS, INC.·Product code PAH·April 4, 2013
MIS REPLACEMENT INSERTER/EXTRACTOR PAD
FDA Adverse Event
Malfunction
·ZIMMER INC·Product code HWA·February 15, 2011
CONTAK RENEWAL 3 RF
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code NIK·May 8, 2008
Misys Laboratory version 5.3
FDA Recall
Terminated
·Sunquest Information Systems·Product code JQP·November 15, 2002
Thoratec HeartMate 3, LVAS Implant Kit, REF:106524INT, Sterile EO, RxOnly
FDA Enforcement
Class I
·Ongoing·Thoratec Corp.·May 8, 2024
Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly
FDA Enforcement
Class I
·Ongoing·Thoratec Corp.·May 8, 2024
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012