13 results · 28ms · Sources: EU EUDAMED, US FDA

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15.5 FR DECATHLON GOLD, FUNNEL TIPS, COATED HEMODIALYSIS CATHETER, DFC19SH24, DFC23SH28, DFC27SH32, DFC31SH36, DFC35SH40

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

PASS SPINAL SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

ZEUS ROBOTIC SURGICAL SYSTEM

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

STELLARIS VISION ENHANCEMENT SYSTEM

FDA Adverse Event
Injury ·BAUSCH + LOMB·Product code HQC·February 5, 2026

STELLARIS ELITE VISION ENHANCEMENT SYSTEM

FDA Adverse Event
Injury ·BAUSCH + LOMB·Product code HQC·March 1, 2022

NEXGEN LPS-FLEX PROLONG ARTICULAR SURFACE

FDA Adverse Event
Malfunction ·ZIMMER, INC.·Product code JWH·April 12, 2013

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·April 19, 2011

PROLENE POLYPROPYLENE SUTURE

FDA Adverse Event
Injury ·ETHICON, INC.·Product code GAW·June 18, 2008

STELLARIS POWER SUPPLY II

FDA Adverse Event
Malfunction ·BAUSCH + LOMB·Product code HQC·August 1, 2023

OSSEOTITE CERTAIN IMPLANT 4 X 11.5MM

FDA Adverse Event
Injury ·BIOMET 3I·Product code DZE·December 18, 2023

Bander Ureteral Diversion Open-End Stent Set, Global Product No. G14822 G14823

FDA Enforcement
Class II ·Terminated·Cook Inc.·February 12, 2020

Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

FDA Enforcement
Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015