9 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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POWDER-FREE BLUE NITRILE EXAMINATION GLOVES (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)
FDA 510(k)
FDA Class 1
·General Hospital
JOE LUB HELMET CONDOM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
BIOCUFF, MODELS 225718, 225728, 225736, 235718, 235728, 235736
FDA 510(k)
FDA Class 2
·Orthopedic
ASR UNI FEMORAL IMPL SIZE 47
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·April 10, 2013
ACCU-CHEK FLEXLINK PLUS INFUSION SET
FDA Adverse Event
Malfunction
·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code FRN·April 4, 2011
ILLUMENA-SYR-W/HF-150ML BX50
FDA Adverse Event
Malfunction
·COVIDIEN·Product code DXT·May 16, 2008
CT EXPRES
FDA Adverse Event
Injury
·BRACCO INJENEERING S.A.·Product code IZQ·September 27, 2023
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
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018