11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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STRYKER RF COAXIAL BIPOLAR ELECTRODES & CANNULAE
FDA 510(k)
FDA Class 2
·Neurology
BACT/ALERT® SN CULTURE BOTTLE
FDA Adverse Event
Malfunction
·BIOMERIEUX, INC·Product code MDB·September 11, 2015
PASS SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MODIFICATION TO EDI VERIS SYSTEM
FDA 510(k)
FDA Class 2
·Ophthalmic
POLYFLUX 17L
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - HECHINGEN BADEN DIALYZER·Product code KDI·January 14, 2020
HEART START XL
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·March 12, 2013
RUSCH SAFETY CLEAR PLUS MURPHY/CUFFED ET TUBE
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code BTR·February 25, 2011
VITALITY DS VR
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008
Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x50 mm Catalog Number: 18965050S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
FDA Enforcement
Class II
·Terminated·Stryker GmbH·June 24, 2020
LGN PRSFT STEM 10MMX220MM STRT
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JWH·October 19, 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