13 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TRUSELECT Microcatheter
FDA 510(k)
FDA Class 2
·Cardiovascular
DJO SURGICAL
FDA UDI
Encore Medical, L.P.·00190446888284·Special, EMPOWR Partial Knee Distal Resection G...
HHM
FDA UDI
Oticon A/S·05707131355249·G300 SC, MINIRITE 312 2.4G C057 HHM
7450 RV2 MASK
FDA UDI
HANS RUDOLPH, INC.·00874750002702·HEADGEAR SMALL V2MASK REUSEBL
BILAYER MATRIX WOUND DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
LIV LINDE INTERGRATED VALVE-PORTABLE OXYGEN SYSTEM, MODEL M706
FDA 510(k)
FDA Class 1
·Anesthesiology
GE OEC 9600
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·October 21, 2008
CAPSURE SP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 11, 2011
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE·Product code KDJ·July 2, 2013
EVIS EXERA LLL COLONOVIDEOSCOPE
FDA Adverse Event
Malfunction
·OLYMPUS MEDICAL SYSTEMS CORP.·Product code FDF·February 9, 2022
EVIS EXERA II COLONOVIDEOSCOPE
FDA Adverse Event
Malfunction
·AIZU OLYMPUS CO., LTD.·Product code FDF·December 13, 2022
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
EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·February 3, 2021