22 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
DIATEK CANNON-CATH #CC2400, CC2800, CC3200, CC3600,CC5500. CC2400PC, CC2800PC, CC3200PC(32 CM), CC3200PC(36 CM)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Zirlux
FDA UDI
HENRY SCHEIN, INC.·H65890103990·Zirlux UCLA Plastic Abut N Eng
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033211892·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033211885·
neoWave LS
FDA UDI
XENIX MEDICAL LLC·00818345024045·Paddle Shaver, 9mm
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033211939·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033211908·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033211878·
InTess Lumbar Cage
FDA UDI
Kalitec Direct LLC·B07312K0103090·Shaver, Closed, 9mm
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033211915·
QUICK SET
FDA Adverse Event
Injury
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·October 24, 2025
ZYNERGY Z3K BALLOON GUIDED PACING AND MONITORING CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
STC PCP INTERCEPT MICRO-PLATE EIA, MODEL 11541
FDA 510(k)
FDA Unclassified
·Unknown
ACIST
FDA Adverse Event
Injury
·ACIST MEDICAL SYSTEMS, INC.·Product code DXT·February 10, 2012
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC., USA·Product code LFR·May 11, 2007
SUMMIT BASIC CEMENTED SZ 2
FDA Adverse Event
Injury
·JOHNSON & JOHNSON MEDICAL (DEPUY - SUZHOU) LTD. 3·Product code JDI·March 19, 2013
NEEDLE
FDA Adverse Event
Death
·Product code FMI·March 3, 2011
ACIST
FDA Adverse Event
Malfunction
·ACIST MEDICAL SYSTEMS, INC.·Product code DXT·April 20, 2007
ACIST
FDA Adverse Event
Injury
·ACIST MEDICAL SYSTEMS, INC.·Product code DXT·February 10, 2012
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