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

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ENVOY GUIDING CATHETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04064984699595·GENUMEDI PSS BLUE, SIZE VII

ADSON TISSUE FORCEPS

FDA UDI
SONTEC INSTRUMENTS, INC.·00192896023543·ADSON TISSUE FORCEPS WITH TUNGSTEN CARBIDE SERR...

K140347

FDA Adverse Event
Injury ·DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB)·Product code DZE·May 6, 2021

K140347

FDA Adverse Event
Injury ·DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB)·Product code DZE·May 6, 2021

HANSON SCAR ADE

FDA 510(k)
FDA Class 1 ·General, Plastic Surgery

GELSCAN, MODEL 1206

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

UNKNOWN DVR PLATE

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code JWJ·August 15, 2017

LOGIC FEMORAL PS POR RIGHT SZ 2

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JWH·February 10, 2025

LOGIC CR FEMORAL POR, LEFT, SZ 3.5

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JWH·December 11, 2024

CATHETER MOUNT

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BZO·August 6, 2014

V40 COCR LFIT HEAD 36MM/0

FDA Adverse Event
Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code JDI·October 3, 2014

PROLIFT +M PELVIC FLOOR REPAIR

FDA Adverse Event
Injury ·ETHICON, INC.·Product code OTP·May 31, 2013

ENDO GIA ROTICULATOR 45-4.8 SULU

FDA Adverse Event
Injury ·UNITED STATES SURGICAL·Product code GDW·June 15, 2011

Micro Screen 6 Panel Cup with Adult (AU), Item No. MSCA-6MBAU

FDA Enforcement
Class III ·Terminated·Ameditech Inc·December 30, 2015

SPECIFIC DEVICE NOT REPORTED

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JWH·April 26, 2023

Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEMTM S-ICD Pulse Generator

FDA Enforcement
Class II ·Ongoing·Boston Scientific Corporation·September 25, 2019