13 results
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27ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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REPROCESSED SEALED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS
FDA 510(k)
FDA Class 2
·Cardiovascular
Lumitex MD 3.75mm ACMI Reusable Light Cable
FDA UDI
Lumitex, Inc.·00812432021559·
DAISY FUENTES
FDA UDI
FGX INTERNATIONAL INC.·00193033442067·
DAISY FUENTES
FDA UDI
FGX INTERNATIONAL INC.·00193033442043·
DAISY FUENTES
FDA UDI
FGX INTERNATIONAL INC.·00193033442050·
ASCENT KNEE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
RADIOFIX
FDA 510(k)
FDA Class 2
·Orthopedic
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·March 20, 2013
ASR UNI FEMORAL IMPL SIZE 53
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·February 24, 2011
ACUFIX
FDA Adverse Event
Injury
·ABBOTT SPINE·Product code HTW·March 12, 2008
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
Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018
StimQ Peripheral Nerve Stimulator System (PNS) Model STQ4-SPR-BO US - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain.
FDA Enforcement
Class II
·Ongoing·Stimwave Technologies Inc·September 9, 2020