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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