8 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NITRITECH OR MULTIPLE PRIVATE LABEL NON-STERILE POWDER FREE NITRILE PATIENT EXAMINATION GLOVE
FDA 510(k)
FDA Class 1
·General Hospital
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450503324·
10600 DEFLECTABLE CATHETER SYSTEM, MODEL 10600
FDA 510(k)
FDA Class 2
·Cardiovascular
OTRES TOOTHBRUSH SANITIZER MODEL TB100W
FDA 510(k)
FDA Class 1
·Dental
ACCU-CHEK ® LINKASSIST
FDA Adverse Event
Malfunction
·ROCHE DIABETES CARE AG·Product code KZH·May 6, 2013
PINNACLE MTL INS NEUT36IDX52OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910 ·Product code KWA·September 16, 2014
ACRYSOF IQ TORIC
FDA Adverse Event
Malfunction
·ALCON RESEARCH, LTD./HUNTINGTON·Product code HQL·April 6, 2011
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