9 results
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26ms
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Sources: EU EUDAMED, US FDA
PODOFLEX EXERCISER-PASSIVE-FOOT/ANKLE
FDA 510(k)
FDA Class 1
·Physical Medicine
Map-iT
FDA UDI
ACCESS POINT TECHNOLOGIES, INC.·00818083016418·STR, 4 electrode, MPD-S-L, 5mm electrode spacing
SOFTLASE PRO, ORTHOLASE AND HYGIENELASE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
GYROSCAN INTERA (R7.5)
FDA 510(k)
FDA Class 2
·Radiology
FOLEY CATHETERS
FDA Adverse Event
Malfunction
·UNOMEDICAL SDN BHD·Product code KOD·May 8, 2014
PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES
FDA Adverse Event
Malfunction
·INVACARE SUZHOU·Product code BTI·January 8, 2013
M2A MAGNUM MODULAR HEAD 44MM HEAD DIAMETER
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·November 17, 2010
BlockAid Cut Resistant Surgical Glove Liners, combine stainless steel and synthetic fibers woven together to form a cut resistant glove material. Blockaid Cut Resistant Surgical Glove Liners are to be worn between two layers of surgical gloves. Item Number: 650126, 650127, 650128, 650129, 650130, 650131
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·February 21, 2018
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