13 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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KSEA SAWAHLE ELECTROMECHANICAL MORCELLATOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·00304040012604·Zirlux 16+ A3 95X25
PROGRESS
FDA UDI
ABBOTT VASCULAR INC.·08717648144134·HI-TORQUE PROGRESS 140T Guide Wire .014 Straigh...
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0112410·Awl Tap, 4.5 mm, Fixed Sleeve
ACON COC ONE STEP COCAINE TEST STRIP, ACON COC ONE STEP COCAINE TEST DEVICE
FDA 510(k)
FDA Class 2
·Clinical Toxicology
35/CD CINECONVERTER
FDA 510(k)
FDA Class 2
·Radiology
PERCLOSE¿ PROSTYLE¿
FDA Adverse Event
Injury
·ABBOTT VASCULAR INC.·Product code MGB·March 20, 2025
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR·Product code MGB·May 6, 2021
PERCLOSE PROSTYLE SUTURE-MEDIATED CLOSURE AND REPAIR SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR·Product code MGB·August 9, 2023
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 19, 2013
GELWEAVE
FDA Adverse Event
Other
·VASCUTEK LTD.·Product code DSY·February 25, 2011
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC·Product code JAA·March 11, 2008
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