21 results · 20ms · Sources: EU EUDAMED, US FDA

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LIPIDURE REWETTING DROPS

FDA 510(k)
FDA Class 2 ·Ophthalmic

Implant Prosthetics

FDA UDI
Preat Corporation·00842092130896·NobelActive™/Conical-compatible RP Straight Mul...

Custom Procedure Kit

FDA UDI
MEDIVATORS INC.·40677964008960·Endo Carry-On Procedure Kit

Implant Prosthetics

FDA UDI
Preat Corporation·00842092116739·NobelActive™/Conical-compatible RP Straight Mul...

PowerPICC SOLO

FDA UDI
Bard Access Systems, Inc.·00801741202186·Catheter Placement Kit

PedFuse®

FDA UDI
SPINEFRONTIER, INC.·00190361008309·PedFuse ReTurn, Hex, CNL, 9.0mm x 75mm

DATEX-OHMEDA TEC 6 PLUS ANESTHESIA VAPORIZER, DATEX-OHMEDA TEC 6 PLUS NAD VARIANT ANESTHESIA

FDA 510(k)
FDA Class 2 ·Anesthesiology

HARDYDISK TICARILLIN 75MCG

FDA 510(k)
FDA Class 2 ·Microbiology

9900

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 27, 2013

PRECISION

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·February 18, 2011

CARESENSE BSN-020

FDA Adverse Event
Injury ·NURSE ASSIST, INC.·Product code KMI·February 19, 2008

ANIMAS VIBE

FDA Adverse Event
Malfunction ·ANIMAS LLC·Product code OYC·September 3, 2018

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·August 8, 2016

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·July 1, 2016

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·November 1, 2016

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·July 12, 2016

Salvart Oral Moisturizer, 2.5 fl.oz. aerosol cans, OTC, Item Number 0386-0009-75. Distributed by: Gebauer Co., Cleveland, OH.

FDA Recall
Terminated ·Gebauer Co·Product code LFD·February 23, 2004

Salivart Oral Moisturizer, packaged in 2.5 fluid ounce (73.9 mL) spray cans, Part Number: 0386-0009-75; Manufactured by Gebauer Company, Cleveland, Ohio

FDA Recall
Terminated ·Gebauer Company·Product code LFD·January 19, 2007

ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Model 96281 is intended for use with either adult or neonatal patient populations in a hospital environment.

FDA Enforcement
Class II ·Terminated·Spacelabs Healthcare, Llc·February 5, 2014

Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy. Used to provide treatment for neonatal Hyperbilirubinemia. 006224 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad 006254 neoBLUE blanket LED Light Box 006895 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad 007299 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad EUR 007300 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad EUR 007296 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad UK 007298 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad UK 007301 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad AUS 007296 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad AUS

FDA Enforcement
Class II ·Terminated·Natus Medical Incorporated·December 21, 2016