12 results
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20ms
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Sources: EU EUDAMED, US FDA
THEKEN CPOD/LPOD VERTEBRAL BODY REPLACEMENT SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
BUSCH®, BNA®
FDA UDI
BUSCH & CO. GmbH & Co. KG·D8120320641·Diamond, pear, COOL DIAMANT, medium grit
Silicone Drainage Tube
FDA UDI
FORTUNE MEDICAL INSTRUMENT CORP.·04711182603229·
HEMOCLEAN
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
COMFIT CHEMO PLUS POWDER FREE BLUE NITRILE EXAMINATION GLOVES, NON STERILE (TESTED FOR USE WITH CHEMOTHERAPY DRUG) LABEL
FDA 510(k)
FDA Class 1
·General Hospital
OMNIPOD INSULIN PUMP
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code LZG·March 6, 2013
OT ULTRA METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·March 28, 2011
KENTROX SL 65/16
FDA Adverse Event
Injury
·BIOTRONIK GMBH AND CO.·Product code LWS·April 21, 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
Spirit Plus Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016
Spirit Select Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016
The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018