14 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MAMMOTOME HAND HELD PROBE, MODEL MHH8
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TruForm
FDA UDI
Rmo, Inc.·00885797099815·MX 1-2 BI BD KT N/L UNIV 131
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450653319·
Mount Transition Plate
FDA UDI
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·06944904092492·
ENDOTAK C
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS·Product code LWS·May 5, 1999
YORAMED, MODEL T-202
FDA 510(k)
FDA Class 2
·Neurology
ERCHINGER HEMORRHOIDAL LIGATORS: SUCTION LIGATORS, MOD. ERCHINGER, RUDD, MCGIVNEY MOD. ERCHINGER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BIO-CORKSCREW SUTURE ANCHOR
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code MAI·February 21, 2007
OT PING ENHANCED METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 14, 2013
ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - COSTA RICA·Product code MCX·February 28, 2011
DAMON COPPER NITI WIRE
FDA Adverse Event
Malfunction
·ORMCO CORPORATION·Product code DZC·February 28, 2008
smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD, Inc.·December 4, 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
Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly
FDA Enforcement
Class II
·Ongoing·Covidien·August 28, 2024