23 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MODIFICATION TO: APEX KNEE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
HNC-63-INT NEUROVASCULAR ARRAY COIL
FDA 510(k)
FDA Class 2
·Radiology
SMALL VOLUME NEBULIZER
FDA 510(k)
FDA Class 2
·Anesthesiology
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523180882·Tesera-K XL Cage - 22 x 60 x 14mm A, 7°
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523180851·Tesera-K XL Cage - 22 x 60 x 8mm A, 7°
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523180875·Tesera-K XL Cage - 22 x 60 x 12mm A, 7°
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523180912·Tesera-K XL Cage - 22 x 60 x 12mm A, 12°
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523180868·Tesera-K XL Cage - 22 x 60 x 10mm A, 7°
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523180905·Tesera-K XL Cage - 22 x 60 x 10mm A, 12°
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523180899·Tesera-K XL Cage - 22 x 60 x 16mm A, 7°
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523180936·Tesera-K XL Cage - 22 x 60 x 16mm A, 12°
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523180929·Tesera-K XL Cage - 22 x 60 x 14mm A, 12°
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES BETTLACH·Product code HWC·September 23, 2015
EXPEDIUM PRE-CUT HEX END ROD, 5.5X300MM, TI
FDA Adverse Event
Injury
·DEPUY SPINE, INC.·Product code NKB·April 27, 2011
PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES
FDA Adverse Event
MEDEL S.P.A.·Product code BTI·April 23, 2013
ATLAS II VR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 11, 2008
DIMENSION EXL WITH LM
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS·Product code JJE·June 13, 2013
BLAKE DRAIN UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GBX·February 22, 2018
DIMENSION EXL 200
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC·Product code JJE·July 23, 2013
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