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