12 results
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27ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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RADIX CERVICAL PLATE
FDA 510(k)
FDA Class 2
·Orthopedic
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091033951·Baltic Denture System BDLoad BDLoad ↓ Mm6 PLSEu...
Masterline
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746164590·INSTRUMENT MASTERLINE SHEAR AND HOLD DISTAL END...
INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BAR, BZD, COC, MET1000, MOR200
FDA UDI
ALFA SCIENTIFIC DESIGNS, INC.·10796918001419·INSTANT-VIEW Multi-Drugs of Abuse Urine Test
AM...
PECTOFIX STERNAL REPAIR WIRE
FDA 510(k)
FDA Class 2
·Orthopedic
SANDHILL SCIENTIFIC PEDIATEC PH PROBE
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
MODULAR POST TM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·December 21, 2022
UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code JGS·April 3, 2013
REPAIR ENLITE
FDA Adverse Event
Malfunction
·STRYKER NAVIGATION·Product code HAW·March 23, 2011
ENDURON 10D 54OD X 28ID
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWY·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