16 results
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27ms
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Sources: EU EUDAMED, US FDA
TAO EMBRYO TRANSFER CATHETER SYSTEM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Zirlux
FDA UDI
HENRY SCHEIN, INC.·H65890122200·Zirlux Titanium Abutment 4.5 mmH, Non-Engaging,...
INTER FIX™ RP Threaded Fusion Device
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00673978957524·22X20 INTERFIXRP FUSION DEVICE
CORTICAL LOCKING SCREW 3.5mm x 22mm
FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665007619·
Battalion
FDA UDI
ALPHATEC SPINE, INC.·00840967187037·Battalion, LLIF Trial, 10°, 22 mm Wide, 20 mm X...
PediPlate
FDA UDI
ORTHOPEDIATRICS CORP.·00841132109069·O-PLATE 20mm
NIDO Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07315K0120200·Screwdriver, Modular Bone Screws
NITRILE EXAM GLOVE, PRE-POWDERED, COLOR BLUE
FDA 510(k)
FDA Class 1
·General Hospital
XTRACTOR, MODEL M143
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
OMRIX PRESSURE REGULATOR
FDA Adverse Event
Other
·OMRIX BIOPHARMACEUTICALS LTD·Product code FMF·August 28, 2013
FREESTYLE
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC,USA·Product code LFR·May 16, 2007
CHARGING SYSTEM
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·March 12, 2013
AQUATRACK HYDROPHILIC GUIDE WIRE
FDA Adverse Event
Malfunction
·ARGON MEDICAL DEVICES INC.·Product code DQX·February 2, 2011
CORAIL AMT COXA VARA NECK SEGMENT (KLA) Pro. Code L20432 Product Usage: The affected CORAIL Neck Trials are surgical instruments used in CORAIL total and partial hip arthroplasty.
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·April 17, 2019
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 Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018