22 results · 35ms · Sources: EU EUDAMED, US FDA

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O-Arm O2 Imaging System

FDA 510(k)
FDA Class 2 ·Radiology

SimPro™ Now

FDA UDI
Wellspect AB·07392532188916·Single Use Urinary Catheter with water sachet. ...

RUSCH

FDA UDI
TELEFLEX INCORPORATED·14026704734334·RUSCH POLARIS FO BLADE WIS-HIPPLE 1

SimPro™ Now

FDA UDI
Wellspect AB·07333387032689·Single Use Urinary Catheter with water sachet. ...

JOBST Elvarex

FDA UDI
BSN-Jobst GmbH·04019702579925·ELVAREX 1/THIGH HIGH/SLANT-CLOSED TOE/SLIP FORM...

Pedicle Screw Instruments Kit

FDA UDI
XENCO MEDICAL LLC·B064XM11510001·

MultiPulse HoPLUS

FDA UDI
Asclepion Laser Technologies GmbH·04058784000996·Holmium Laser for Surgery

TALOS®-C HA

FDA UDI
MEDITECH SPINE, LLC·B167521510000·

JOBST Elvarex

FDA UDI
BSN-Jobst GmbH·04019702617580·E2/AD/CT-E/ZI/CB

FORTITUDE VUE VERTEBRAL BODY REPLACEMENT DEVICE

FDA 510(k)
FDA Class 2 ·Orthopedic

WELLMIEN SURGICAL MASK

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

AVANCE CS2

FDA Adverse Event
Malfunction ·DATEX-OHMEDA, INC.·Product code BSZ·December 16, 2020

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

FDA Adverse Event
Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 8, 2014

POWERED WHEELCHAIR

FDA Adverse Event
Malfunction ·INVACARE TAYLOR STREET·Product code ITI·June 6, 2013

ASR ACETABULAR IMPLANT 56

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·June 29, 2011

LIFE SCOPE G9

FDA Adverse Event
Malfunction ·NIHON KOHDEN CORPORATION·Product code MHX·June 13, 2024

LIFE SCOPE G9

FDA Adverse Event
Malfunction ·NIHON KOHDEN CORPORATION·Product code MHX·October 27, 2023

ACCESS VITAMIN B12

FDA Adverse Event
Injury ·BECKMAN COULTER, INC·Product code CDD·January 27, 2025

ACCESS VITAMIN B12

FDA Adverse Event
Injury ·BECKMAN COULTER, INC·Product code CDD·January 29, 2025

REF: 915-1000 Lactosorb, Office Fixation Kit, 1 Screwdriver, 1 Tap Handle, 1 Drill Bit, 1 Screw Extractor, 1 Self Drilling Tap, S/S. Aluminum , Teflon, Ra del. Non Sterile Product. W.LORENZ SURGICAL, Walter Lorenz Surgical, Inc. 1520 Tradeport Drive Reply to Post Office Box 18009 Jacksonville, Florida 32229-8009 USA 1-800-874-7711. Aid in the alignment and stabilization of bone in the oral cranio-maxillofacial skeletal system.

FDA Recall
Terminated ·Biomet Microfixation, Inc.·August 6, 2008