315 results · 22ms · Sources: EU EUDAMED, 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