11 results
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28ms
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Sources: EU EUDAMED, US FDA
CYNERGY MODEL 184
FDA 510(k)
FDA Class 2
·Cardiovascular
N/A
FDA UDI
GEORGE TIEMANN & CO.·B5828015960·ELEVATOR, SURGICAL, GENERAL & PLASTIC SURGERY
Sklar
FDA UDI
SKLAR CORPORATION·10649111456800·LLOYD DAVIS REC SCISS CVD10.5 INCHES
KIMBERLY-CLARK PURPLE NITRILE POWDER-FREE EXAM GLOVE (CHEMOTHERAPY GLOVE) AND KIMBERLY-CLARK PURPLE NITRILE XTRA POWDER-
FDA 510(k)
FDA Class 1
·General Hospital
LIFERX
FDA 510(k)
FDA Class 2
·Radiology
LIFEPAK(R) 1000 DEFIBRILLATOR
FDA Adverse Event
Death
·PHYSIO-CONTROL, INC·Product code MKJ·May 9, 2014
HEARTSTREAM FR2
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·October 18, 2012
PRECISION XTRA/OPTIUM
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE LIMITED UK·Product code NBW·September 25, 2007
Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021
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
Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018