21 results · 23ms · Sources: EU EUDAMED, US FDA

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MultiCut Solo

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

MAXZERO EXTENSION SET WITH NEEDLESS CONNECTOR

FDA 510(k)
FDA Class 2 ·General Hospital

DATEX-OHMEDA TRUSAT PULSE OXIMETER AND ACCESSORIES, MODEL 3500

FDA 510(k)
FDA Class 2 ·Cardiovascular

MAXZERO

FDA Adverse Event
Malfunction ·BECTON DICKINSON·Product code FPA·March 17, 2026

NC TREK CORONARY DILATATION CATHETER

FDA Adverse Event
Malfunction ·AV-TEMECULA-CT·Product code LOX·November 10, 2014

ASR ACETABULAR CUPS 50

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL·Product code KWA·September 9, 2011

DUROM HIP

FDA Adverse Event
Other ·ZIMMER GMBH·Product code KWA·July 18, 2013

BD MAXZERO¿ MULTI-FUSE PRESSURE RATED EXTENSION SET

FDA Adverse Event
Malfunction ·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·March 21, 2023

BD MAXZERO¿ EXTENSION SET

FDA Adverse Event
Malfunction ·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·June 10, 2022

MAXZERO NEEDLELESS CONNECTOR

FDA Adverse Event
Malfunction ·CFN MEXICO 215 SA DE CV·Product code FPA·May 12, 2020

BD MAXZERO¿ MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR

FDA Adverse Event
Malfunction ·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·May 19, 2023

BD MAXZERO¿ MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR

FDA Adverse Event
Malfunction ·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·May 18, 2023

4.9MM HEALX ADV SP BIOC ANCHOR

FDA Adverse Event
Malfunction ·MEDOS INTERNATIONAL SARL·Product code MAI·May 30, 2024

ARROW Endurance Extended Dwell Peripheral Catheter System

FDA Enforcement
Class I ·Ongoing·ARROW INTERNATIONAL Inc.·June 28, 2023

EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_13.2. Phakic Toric Intraocular lens.

FDA Enforcement
Class II ·Ongoing·Staar Surgical Company·December 13, 2023

EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_12.6. Phakic Toric Intraocular lens.

FDA Enforcement
Class II ·Ongoing·Staar Surgical Company·December 13, 2023

EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens.

FDA Enforcement
Class II ·Ongoing·Staar Surgical Company·December 13, 2023

Arrow FiberOptix Intra-Aortic Balloon Catheter Kit: a) REF IAB-05830-LWS; b) REF IAB-05840-LWS; c) REF IAB-05850-LWS

FDA Enforcement
Class I ·Ongoing·ARROW INTERNATIONAL Inc.·June 12, 2024

Arrow UltraFlex Intra-Aortic Balloon Catheter Kit, a) REF IAB-06830-U; b) REF IAB-06840-U; c) REF IAB-06850-U

FDA Enforcement
Class I ·Ongoing·ARROW INTERNATIONAL Inc.·June 12, 2024

BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 11 X 200 MM, Silicone, Sterile, Item 431196.

FDA Enforcement
Class II ·Terminated·Biomet, Inc.·April 15, 2020