14 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VALIDATE CHEM 2 CALIBRATION VERIFICATION TEST SET, MODEL 10002
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·00304040008980·Zirlux 16+ A4 89x17x22
n/a
FDA UDI
Ortho Development Corporation·00822409072309·DAA Canal Finder (BUD)
First Aid Component - Miller & Long
FDA UDI
Certified Safety Manufacturing, Inc.·00766588121185·First Aid Component - Miller & Long
Life Instruments
FDA UDI
Life Instrument Corporation·M930701211800·Shaver 18mm
IPP INFLATABLE PENILE PROSTHESIS
FDA Adverse Event
Injury
·MENTOR UROLOGY, INC.·Product code FHW·May 2, 1997
RADIESSE DERMAL FILLER
FDA Adverse Event
Injury
·BIOFORM MEDICAL, INC.·Product code LMH·August 21, 2009
STOCKERT COMPACT SYSTEM VERSION 2.0
FDA 510(k)
FDA Class 2
·Cardiovascular
NORMED MANDIBULAR FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Dental
PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAW·June 28, 2018
COMPLETE SE BILIARY
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code FGE·March 20, 2013
ACCU-CHEK SPIRIT COMBO
FDA Adverse Event
Malfunction
·ROCHE INSULIN DELIVERY SYSTEMS INC·Product code LZG·March 4, 2011
GORE SEAMGUARD® BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code FTM·August 15, 2014
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