76 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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INCITE ANCHORED CERVICAL INTERBODY (ACI) FUSION DEVICE
FDA 510(k)
FDA Class 2
·Orthopedic
Likorall™ overhead lift
FDA UDI
Liko AB·00887761979772·Overhead track patient lifting/transfer system
ArgenZ HT+ 98x12 OM2
FDA UDI
ARGEN CORPORATION, THE·D818122008·Dental porcelain/ceramic restoration kit
EVOS Lumbar Interbody System
FDA UDI
Cutting Edge Spine, LLC·00841193110059·HA PEEK EVOS Straight, ,8mmx9mmx 22mm , BICONVE...
GEN4 Direct Access
FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828106191·GEN4 Direct Access
LIGAMAX-5MM ENDO CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC·Product code FZP·July 21, 2008
CARDIMA ABLATION SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
GLIDESHEATH
FDA 510(k)
FDA Class 2
·Cardiovascular
POWERLINK SYSTEM
FDA Adverse Event
Injury
·ENDOLOGIX, INC·Product code MIH·October 20, 2010
GLIDESHEATH SLENDER NITINOL (CONVENIENCE KIT)
FDA Adverse Event
Malfunction
·TERUMO MEDICAL CORPORATION·Product code DYB·February 21, 2018
SPIDERFX EMBOLIC PROTECTION
FDA Adverse Event
Injury
·EV3 INC.·Product code NTE·May 21, 2013
SYMBIQ 3.13 SINGLE C
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·September 19, 2014
MIS FEMORAL INSERTER/EXTRACTOR
FDA Adverse Event
Malfunction
·ZIMMER, INC.·Product code HWA·May 24, 2011
GLIDESHEATH SLENDER NITINOL (CONVENIENCE KIT)
FDA Adverse Event
Malfunction
·TERUMO MEDICAL CORPORATION·Product code DYB·December 16, 2019
smiths medical portex, 15mm Double Swivel Connector: a) REF 100/255/150; b) REF 100/255/150JP; c) REF 100/255/150 JS
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·October 30, 2024
HydraGlide Heparin Coated Silicone Thoracic Catheters - Straight, Atrium Code # 14132, Size (Fr) 32, # Eyelets 6,
FDA Recall
Terminated
·Atrium Medical Corporation·Product code GBZ·May 12, 2008
HydraGlide Heparin Coated Silicone Thoracic Catheters - Straight, Atrium Code # 14124, Size (Fr) 24, # Eyelets 6, 10 per case
FDA Recall
Terminated
·Atrium Medical Corporation·Product code GBZ·May 12, 2008
ATP HydraGlide Trocar - Includes Tapered ATP Stylet, Atrium Code # 9420, Size (Fr) 20, # Eyelets 2, 10 per case
FDA Recall
Terminated
·Atrium Medical Corporation·Product code GBS·May 12, 2008
HydraGlide Heparin Coated Silicone Thoracic Catheters - Straight, Atrium Code # 14120, Size (Fr) 20, # Eyelets 5, 10 per case
FDA Recall
Terminated
·Atrium Medical Corporation·Product code GBZ·May 12, 2008
ATP HydraGlide Trocar - Includes Tapered ATP Stylet, Atrium Code # 9408, Size (Fr) 8, # Eyelets 2, 10 per case
FDA Recall
Terminated
·Atrium Medical Corporation·Product code GBS·May 12, 2008