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

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VASOBand Vascular Compression Device

FDA 510(k)
FDA Class 2 ·Cardiovascular

Ophthalmic Cannula

FDA UDI
KATENA PRODUCTS, INC.·00841668114155·KRATZ POLISHER 23GA END (PK/10)

Ophthalmic Hooks

FDA UDI
KATENA PRODUCTS, INC.·00841668114292·SINSKEY IOL HOOK STR (BX/3)

Ophthalmic Cannula

FDA UDI
KATENA PRODUCTS, INC.·00841668113783·AIR INJECT CANNULA 25GA

GENERAL SURGICAL LAPAROSCOPES

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

MODIFICATION TO BIOTRONIK'S STERILIZATION PROCESS

FDA 510(k)
FDA Class 3 ·Cardiovascular

SELECT SECURE

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO, INC.·Product code NVN·August 11, 2011

HEARTSTART MRX

FDA Adverse Event
Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·July 23, 2014

EMAX 2 PLUS MOTOR

FDA Adverse Event
Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBC·July 3, 2013

EQUINOXE RS GLENOID PLATE R POST AUG, 8 DEG, RIGHT

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code KWT·August 7, 2023

UNKNOWN SHOULDER COMPONENTS

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code KWT·May 20, 2024

Olympus Sterile Optical Laser Fiber, single use and reusable

FDA Enforcement
Class II ·Terminated·Quanta System, S.p.A.·June 16, 2021

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

Model Number L211 PROPONENT DR SL MRI Pacemaker

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·January 22, 2025