21 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SICKLE-CHEX SOLUBILITY KIT
FDA 510(k)
FDA Class 2
·Hematology
HairCheck-DT (Cocaine)
FDA UDI
Quest Diagnostics·00868586000209·HairCheck-DT (Cocaine) is an ELISA test kit use...
Safco Shotgum Needles
FDA UDI
SAFCO DENTAL SUPPLY CO.·D72310236563·Safco Shotgum needles 27g long 100/box
ActivHeal
FDA UDI
ADVANCED MEDICAL SOLUTIONS LIMITED·15032749023653·AQUAFIBER EXTRA HPD 41-2AP 20x30cm
PLANMED SOPHIE & PLANMED SOPHIE CLASSIC
FDA 510(k)
FDA Class 2
·Radiology
X-POSURE SYSTEM VERSION 2 MAMMO
FDA 510(k)
FDA Class 2
·Radiology
CONTOUR
FDA Adverse Event
Injury
·BAYER HEALTHCARE, LLC·Product code NBW·April 30, 2010
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·June 18, 2019
VERTEX® RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·August 16, 2017
VERTEX® RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·March 3, 2017
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·October 18, 2018
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Death
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·March 27, 2013
ACRYSOF TORIC
FDA Adverse Event
Other
·ALCON RESEARCH, LTD. / HUNTINGTON·Product code HQL·March 3, 2011
CD1800 ANALYZER
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTIC DIVISION/CELL DYN·Product code GKZ·April 1, 2008
VERTEX® RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·March 17, 2017
VERTEX® RECONSTRUCTION SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·July 15, 2024
DERMAHOOK 1/2 HOOK 10 PKG/BX 6 HKS/PKG
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code HAO·May 6, 2019
DERMAHOOK 1/2 HOOK 10 PKG/BX 6 HKS/PKG
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code HAO·May 6, 2019
DERMAHOOK 1/2 HOOK 10 PKG/BX 6 HKS/PKG
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code HAO·May 6, 2019
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