12 results
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28ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MINITAPE URETHRAL SLING
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450169681·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450218518·
TEMPORARY PACEMAKER EXTENSION CABLE, MODELS 5235, 5235A, 5235V, TEMPORARY PACEMAKER SURGICAL EXTENSION CABLE, MODELS 528
FDA 510(k)
FDA Class 2
·Cardiovascular
CT/MASTER, VERSION 1.0
FDA 510(k)
FDA Class 2
·Radiology
REGENEREX RINGLOC+ REV CUP 54MM SZ 23
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDG·September 25, 2017
PANORAMA CENTRAL STATION
FDA Adverse Event
Malfunction
·MINDRAY DS USA, INC.·Product code MHX·April 30, 2013
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 16, 2014
HIRES 90K
FDA Adverse Event
Malfunction
·ADVANCED BIONICS LLC·Product code MCM·May 11, 2011
TI LOW PROFILE SCREW 6.5X35MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·September 25, 2017
RINGLOC TI LOW PROFILE SCREW 6.5X30MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·September 25, 2017
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