315 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BOREALIS AMPLIFIER (CLEARSIGN), MODEL 2001232 160 CHANNEL VERSION, 2001267 80 CHANNEL VERSION, 2001268 40 CHANNEL VERSIO
FDA 510(k)
FDA Class 2
·Cardiovascular
SILVERVENT
FDA UDI
Andreas Fahl Medizintechnik-Vertrieb GmbH·04051948011036·SILVERVENT 1 ICU, SIZE 6
Ni-Ti - Archwire
FDA UDI
ORMCO CORPORATION·00889989025217·PREF ARCH NI-TI LOWER 16 LARGE PK10
LOCATOR F-Tx
FDA UDI
Zest Anchors, LLC·00840481119477·LOCATOR F-Tx Abutment for Narrow Platform (NP) ...
LOCATOR R-Tx
FDA UDI
Zest Anchors, LLC·00840481110542·LOCATOR R-Tx Abutment for Narrow Platform (NP) ...
Humelock II Cemented Reversible Shoulder
FDA UDI
FX SOLUTIONS·03701037300213·POST EXTENSION TA6V +06 mm CEMENTLESS Ti/HA
EVOS Lumbar Interbody System
FDA UDI
Cutting Edge Spine, LLC·00841193103105·HA PEEK EVOS Curved, , 6mmx9mmx 26mm , FLAT 0 d...
Batrik Brush/Green/BD 6mm/BL 50mm
FDA UDI
Batrik Medical Manufacturing Inc·00690521007697·Brush/Green/BD 6mm/BL 50mm/OL 50cm - Symetric D...
LOCATOR R-Tx
FDA UDI
Zest Anchors, LLC·00840481128707·LOCATOR R-Tx Abutment, Narrow Platform (NP) Tri...
IMMULITE PHENYTOIN, IMMULITE 2000 PHENYTOIN, CATALOG # LKPN1, LKPN5 & L2KPN2, L2KPN6
FDA 510(k)
FDA Class 2
·Clinical Toxicology
DRAINAGE CATHETER OR FOLEY CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
GORE® CARDIOFORM ASD OCCLUDER
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code MLV·August 20, 2019
GORE® CARDIOFORM ASD OCCLUDER
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code MLV·August 19, 2019
Transcatheter Septal Occluder
FDA Pre-Market Approval
FDA Class 3
·GORE HELEX SEPTAL OCCLUDER
GORE® CARDIOFORM ASD OCCLUDER
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code MLV·August 8, 2019
EASYTRAK 2
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code OJX·April 10, 2013
CBCII BLOOD CONVERSATION KIT W/1/8 INCH ROUND PVC
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS PUERTO RICO·Product code CAC·March 14, 2011
SPRINT FIDELIS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·May 8, 2008
GORE® CARDIOFORM ASD OCCLUDER
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code MLV·July 11, 2019
PANEL PHOENIX PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·January 12, 2026