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