21 results
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29ms
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Sources: EU EUDAMED, US FDA
EQUINOX OCCULSION BALLOON SYSTEM MODEL # 104-4015, 104-4018, 104-4021, 104-4023, 104-4026
FDA 510(k)
FDA Class 2
·Cardiovascular
Endo Carry-on Procedure Kit
FDA UDI
MEDIVATORS INC.·40677964055223·Endo Carry-on Procedure Kit Includes Basin, Int...
Accu-Patch Conical Pellets with Tan Color Tape
FDA UDI
SAKAMURA KENKYUSHO, K.K.·04955114013179·50 Units in single pack
BonOs HV
FDA UDI
OSARTIS GmbH·04260056882579·BonOs® HV is a fast-setting acrylic resin for u...
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033102893·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033102855·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033102862·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033102886·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033102879·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033102848·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033102831·
Biosteon® Screw
FDA UDI
BIOCOMPOSITES LTD·15060155710256·The Biosteon® ACL screw is a cannulated single-...
GOLDFINGER DEVICE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
METRISCAN BONE DENSITY SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
CONNECSCR F/INSERTION DHS BLADE
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code LXH·March 19, 2013
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·March 1, 2011
INTELECT MOBILE COMBO
FDA Adverse Event
Other
·CHATTANOOGA GROUP·Product code IPF·March 11, 2008
OT ULTRAMINI
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code MDS·September 13, 2010
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
Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·June 29, 2022