25 results
·
23ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
NITRILE POWDER-FREE EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
ACTIVELIFE
FDA UDI
CONVATEC, PURCHASING DEPARTMENT·00768455101559·Activelife® One-Piece Drainable Pre-Cut Pouch W...
nSpire Health
FDA UDI
NSPIRE HEALTH, INC.·10852417003696·KoKo Standard White Filter Kit with Nose Clip a...
Ligatures
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746156120·LIGATURE 20 STICK SILVER 50/BAG
Ligatures
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746077319·LIGATURE 20 STICK SILVER 50/BAG
COATED VICRYL PLUS ANTIBACTERIAL SUTURE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code GAM·April 20, 2006
COATED VICRYL PLUS ANTIBACTERIAL SUTURE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code GAM·April 20, 2006
COATED VICRYL PLUS ANTIBACTERIAL SUTURE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code GAM·April 20, 2006
COATED VICRYL PLUS ANTIBACTERIAL SUTURE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code GAM·April 20, 2006
MICROVASIVE ZERO TIP AIRWAY RETRIEVAL BASKET, MODELS M00513200 AND M00513210
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
LICOX CMP MONITOR-AC3.1, LICOX IMC OXYGEN CATHETERS-CC1,CC1.SB LUICOX IMC INTRODUCER KITS-IM,IM2,IM3,II1 LICOXIMC TEMPE
FDA 510(k)
FDA Class 2
·Neurology
COATED VICRYL PLUS ANTIBACTERIAL SUTURE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code GAM·April 25, 2006
COATED VICRYL PLUS ANTIBACTERIAL SUTURE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code GAM·April 21, 2006
AMS SPECTRA CONCEALABLE PENILE PROSTHESIS
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS, INC.·Product code FAE·March 22, 2013
PRECISION XTRA
FDA Adverse Event
Malfunction
·Product code NBW·March 17, 2011
INDURA CATHETER
FDA Adverse Event
Malfunction
·RICE CREEK MANUFACTURING·Product code LKK·March 28, 2008
ASAHI PROWATER
FDA Adverse Event
Injury
·ASAHI INTECC CO., LTD.·Product code DQX·June 9, 2019
ASAHI PROWATER
FDA Adverse Event
Injury
·ASAHI INTECC CO., LTD.·Product code DQX·June 9, 2019
Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit REF IM1.S Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Used in direct monitoring of the partial pressure of oxygen.
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corp.·October 30, 2013
Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit REF IM3.SR Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Used in direct monitoring of the partial pressure of oxygen.
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corp.·October 30, 2013