12 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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STARLUX PULSED LIGHT SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091033549·Baltic Denture System BDLoad BDLoad ↓ Ln6 PLSEu...
INSTANT-VIEW Multi-Drugs of Abuse Urine Test BAR, BZD, MET500, MOR300, THC
FDA UDI
ALFA SCIENTIFIC DESIGNS, INC.·10796918000979·INSTANT-VIEW Multi-Drugs of Abuse Urine Test BA...
SIGMA DIAGNOSTICS AUTO D-DIMER CALIBRATOR, MODEL A7971
FDA 510(k)
FDA Class 2
·Hematology
CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM PURPLE RIVETS
FDA 510(k)
FDA Class 2
·Dental
K-WIRE GAMMA 3,2X450 MM
FDA Adverse Event
Malfunction
·STRYKER TRAUMA KIEL·Product code LXH·January 18, 2021
LINER AND SHELL WITH PLASTIC BARRIER 48 MM I.D. 60 MM O.D.
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·May 3, 2023
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·April 3, 2013
PRIDE
FDA Adverse Event
Injury
·PRIDE MOBILITY PRODUCTS CORPORATION·Product code ITI·March 30, 2011
TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC·Product code NIQ·April 24, 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
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