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

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Lucent 3D Spinal System

FDA 510(k)
FDA Class 2 ·Orthopedic

Ophthalmic Cannula

FDA UDI
KATENA PRODUCTS, INC.·00841668114230·LASIK CANNULA FORMS 27GA 4-PORTS

Ophthalmic Cannula

FDA UDI
KATENA PRODUCTS, INC.·00841668114247·VECTIS 2-HOLE 4MM 25GA (PK/10)

Ophthalmic Cannula

FDA UDI
KATENA PRODUCTS, INC.·00841668114162·ROBINS-KRATZ POLISHING CAN, 22GA PK/10

BRAVO

FDA Adverse Event
Malfunction ·ARIZONA DEVICE MANUFACTURING·Product code FFT·November 18, 2008

CORTEZ NEEDLE FREE IV CONNECTOR, MODEL MMD-001

FDA 510(k)
FDA Class 2 ·General Hospital

SPEEDICATH

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

WIENER LAB. CHAGATEST ELISA RECOMNINANTE V.3.0, MODEL 96 TESTS CAT. NR. 1203254

FDA 510(k)
FDA Class 1 ·Microbiology

OXFORD MP SLOT POST CUT GD SML

FDA Adverse Event
Injury ·BIOMET UK LTD.·Product code LXH·December 9, 2025

THERMOPHORE AUTOMATIC MOIST HEAT PACK

FDA Adverse Event
Malfunction ·BATTLE CREEK EQUIPMENT CO.·Product code IRT·October 9, 2008

SPRINT QUATTRO SECURE S

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·August 11, 2011

POWERED WHEELCHAIR

FDA Adverse Event
Malfunction ·UNKNOWN·Product code ITI·July 2, 2013

BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

FDA Enforcement
Class II ·Terminated·Becton Dickinson & Co.·April 21, 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

EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

FDA Enforcement
Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021

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