19 results · 22ms · Sources: EU EUDAMED, US FDA

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SPIES 3D Tip Cam, Image 1 SPIES CCU Image Connect, Image 1 SPIES CCU D-3 Link

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

DeRoyal

FDA UDI
DEROYAL INDUSTRIES, INC.·00749756250207·THERA-BAND® EXERCISE BAND

RZ Medizintechnik GmbH

FDA UDI
RZ-Medizintechnik GmbH·04049197510837·RZ Tebbet Breast Retractor 150x25...

HNM Women Care

FDA UDI
HNM STAINLESS, LLC.·00812171029397·PESSARY, RING #1, W/SUPPORT, 2"

ELITECH CLINICAL SYSTEMS GLUCOSE PAP SL ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL 1 AND 2

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

NXSTAGE SYSTEM ONE

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

Bespa Charcot System

FDA UDI
Kapstone Manufacturing, LLC·00810041320483·Seg Column, Screw, 25

AMIA AUTOMATED PD CYCLER SET

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FKX·December 15, 2020

AMIA AUTOMATED PD CYCLER SET

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FKX·January 12, 2023

RINGLOC-X E1 H/W 56/32MM

FDA Adverse Event
Injury ·BIOMET UK LTD.·Product code LPH·April 11, 2025

EMERGE?

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·June 6, 2013

CATH PKGD: BERMAN 5 FR 8 0CM

FDA Adverse Event
Malfunction ·ARROW INTL., INC.·Product code DQO·June 22, 2011

TRI TS BASEPLATE SIZE 6

FDA Adverse Event
Injury ·STRYKER ORTHOPAEDICS MAHWAH·Product code HSH·September 5, 2008

AMIA AUTOMATED PD CYCLER SET

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FKX·February 15, 2024

Phoenix AST Indicator, Catalog Number 246004

FDA Enforcement
Class II ·Terminated·Becton Dickinson & Co.·March 6, 2019

TR BAND

FDA Adverse Event
Malfunction ·TERUMO MEDICAL CORPORATION·Product code DXC·May 26, 2023

TR BAND

FDA Adverse Event
Malfunction ·TERUMO MEDICAL CORPORATION·Product code DXC·May 26, 2023

Allura Xper FD10 Product Codes: (1)722010, (2) 722026, (3) 722003; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 1, 2025

Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026,

FDA Enforcement
Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025