16 results · 27ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

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