11 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DIRECT DIGITIZER, REGIUS MODEL 210
FDA 510(k)
FDA Class 2
·Radiology
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450291955·
LIFE 2
FDA 510(k)
FDA Class 2
·Dental
STERILE PISTON SYRINGE
FDA 510(k)
FDA Class 2
·General Hospital
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 3, 2013
HEARTSTART XL
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·September 8, 2014
ACCESS® 2 IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·May 18, 2011
BD BBL¿ CHROMAGAR® MRSA II 100MM (20 EACH)
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code JSO·May 2, 2023
PLATE BBL CHROMAGAR MRSA II 90MM 20 EA
FDA Adverse Event
Malfunction
·BECTON DICKINSON GMBH·Product code JSO·June 28, 2021
PENTAX
FDA Adverse Event
Injury
·HOYA CORP.·Product code FDT·July 24, 2015
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