21 results · 20ms · Sources: EU EUDAMED, US FDA

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AXP PLATFORM MARROW XPRESS SYSTEM MODEL 8-5137, 8-5138, 8-5139, 8-5140 (PRIMARY)

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

SchureMed

FDA UDI
SCHUERCH CORPORATION·00810014600277·REUSABLE HEAD AND CHIN STRAP (SET)

SchureMed

FDA UDI
SCHUERCH CORPORATION·00810057373060·Reusable Head & Chin Straps

SchureMed

FDA UDI
SCHUERCH CORPORATION·00810057371240·REUSABLE HEAD AND CHIN STRAP (SET)

MODIFICATION TO CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON SLALOM .018 DELIVERY SYSTEM

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

CARDIONAVIGATOR INFORMATION MANAGEMENT SYSTEM

FDA 510(k)
FDA Class 2 ·Cardiovascular

ZOOM

FDA Adverse Event
Malfunction ·EXTERNAL MANUFACTURER·Product code KRG·April 26, 2013

SOLETRA

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO·Product code MHY·July 24, 2008

DUROM US ACETABULAR COMPONENT 54/48 N

FDA Adverse Event
Injury ·ZIMMER GMBH·Product code KWA·April 28, 2011

UNKNOWN_NEUROVASCULAR_PRODUCT

FDA Adverse Event
Injury ·CONCENTRIC MEDICAL·Product code NRY·December 14, 2012

PLATINUM 1 SERIES

FDA Adverse Event
Malfunction ·ABBOTT MEDICAL OPTICS·Product code KYB·November 20, 2017

PLATINUM 1 SERIES

FDA Adverse Event
Malfunction ·ABBOTT MEDICAL OPTICS·Product code KYB·November 10, 2017

PLATINUM 1 SERIES

FDA Adverse Event
Malfunction ·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code KYB·September 17, 2020

UNFOLDER PLATINUM 1 SERIES

FDA Adverse Event
Malfunction ·AMO PUERTO RICO MFG. INC.·Product code KYB·August 9, 2021

PLATINUM 1 SERIES

FDA Adverse Event
Malfunction ·ABBOTT MEDICAL OPTICS·Product code KYB·March 24, 2016

PLATINUM 1 SERIES

FDA Adverse Event
Malfunction ·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code KYB·April 4, 2018

PLATINUM 1 SERIES

FDA Adverse Event
Malfunction ·JOHNSON AND JOHNSON SURGICAL VISION, INC.·Product code KYB·April 24, 2018

PLATINUM 1 SERIES

FDA Adverse Event
Malfunction ·JOHNSON AND JOHNSON SURGICAL VISION, INC.·Product code KYB·April 2, 2018

PLATINUM 1 SERIES

FDA Adverse Event
Malfunction ·AMO PUERTO RICO MFG. INC.·Product code KYB·January 11, 2021

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