13 results
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20ms
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Sources: EU EUDAMED, US FDA
CYANODONT DENTAL CEMENT
FDA 510(k)
FDA Class 2
·Dental
GRADIA®
FDA UDI
Gc America Inc.·D0479010821·GRADIA PLUS Paste HB-ODB, 3.3ml, 1pc
AXIAL RING HANDLE
FDA UDI
SONTEC INSTRUMENTS, INC.·B09929010820·AXIAL HANDLE WITH SPRING & RATCHET ANGLED
Axial Handle
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896115774·Axial Handle Angled With Spring And Ratchet For...
Symmetry Pennington
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482129272·Forceps 10.0 mm 32.0 cm
NexGen®
FDA UDI
Zimmer, Inc.·00889024201972·
SEALED CALL CORD, 8-PIN DIN, 8FT,TTW
FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828131438·SEALED CALL CORD, 8-PIN DIN, 8FT,TTW
STACKHOUSE SMOKE EVACUATOR, MODELS ST-3000, ST 3100
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LTV2 Series Ventilators
FDA 510(k)
FDA Class 2
·Anesthesiology
QUADRA ASSURA CRT-D, DF-4 CONNECTOR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code NIK·June 30, 2014
LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC.·Product code MKJ·November 10, 2010
URETEX SUPPORT PP HALO NEEDLE KIT X1
FDA Adverse Event
Injury
·SOFRADIM PRODUCTION·Product code FTL·November 8, 2012
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