15 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SP NEWTRON MODULE
FDA 510(k)
FDA Class 2
·Dental
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091033764·Baltic Denture System BDLoad BDLoad Sw6 PLSEbm...
INSTANT-VIEW Multi-Drugs of Abuse Urine Test
FDA UDI
ALFA SCIENTIFIC DESIGNS, INC.·10796918002089·INSTANT-VIEW Multi-Drugs of Abuse Urine Test
AM...
IMMIX BONE GRAFT EXTENDER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MODIFICATION TO EBI SPINELINK SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JIS·March 5, 2012
ACCESS® VITAMIN B12
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code CDD·February 1, 2012
ABRAMS MULTIDENSITY POLYURETHAN FOAM WOUND DRESSING SYSTEM
FDA Adverse Event
Other
·DR LEN'S MEDICAL PRODUCTS·Product code FRO·October 11, 2005
T20 DRIVER BIT
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code MDM·April 3, 2013
UNKNOWN DEPUY PATELLA
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code HTG·March 17, 2011
DEXTRUS 4135
FDA Adverse Event
Injury
·BIOTRONIK GMBH AND CO.·Product code DTB·April 25, 2008
ACCESS® VITAMIN B12
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code CDD·February 1, 2012
UNKNOWN PFM-R DISTAL STEM
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code JDI·March 13, 2018
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
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024