11 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MTP DISPOSABLE EQUIPMENT COVERS, KARL STORZ 15 TOUCH SCREEN
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450210956·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450823118·
WILSON-COOK THRU-THE-SCOPE MECHANICAL LITHOTRIPTOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CEDIA DAU 6-ACETYLMORPHINE ASSAY
FDA 510(k)
FDA Class 2
·Clinical Toxicology
UNK MAMMARY IMPLANT
FDA Adverse Event
Injury
·ALLERGAN (COSTA RICA)·Product code FWM·July 16, 2024
UNK MAMMARY IMPLANT
FDA Adverse Event
Injury
·ALLERGAN (COSTA RICA)·Product code FWM·July 12, 2024
A5 ANESTHESIA SYSTEM
FDA Adverse Event
Malfunction
·MINDRAY DS USA, INC.·Product code BSZ·April 30, 2013
OT VERIO SYNC METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 16, 2014
SM204 M-SERIES W/BIG WHEEL
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·April 20, 2011
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