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

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THERMO SCIENTIFIC CEDIA AMPHETAMINE OFT ASSAY

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

Hader Bar

FDA UDI
Preat Corporation·00842092105481·Hader Servicing Kit

CONKLUSION

FDA UDI
SIGNUS Medizintechnik GmbH·04047844006511·The CONKLUSION Pedicle Screw System is a spinal...

SureLOK Mini Posterior Cervical/Upper Thoracic System

FDA UDI
PRECISION SPINE, INC.·00840019907675·45mm Cervical Crosslink

First Choice Partial Ulnar Head Implant

FDA UDI
Smith & Nephew, Inc.·00885556826522·FIRST CHOICE HEAD 17.5-STEM 4.5

HP-3, BATTETRY OPERATED, FONT WHEEL DRIVE, POWER WHEELCHAIR

FDA 510(k)
FDA Class 2 ·Physical Medicine

MODIFICATION TO PROVIDENT HIP SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

JUVEDERM ULTRA PLUS/30HV (VOLUME UNKNOWN)

FDA Adverse Event
Injury ·PRINGY·Product code LMH·September 4, 2025

CONTEGRA PULMONARY VALVED CONDUIT - SUPPORTED

FDA Adverse Event
Injury ·MEDTRONIC HEART VALVES DIVISION·Product code MWH·July 6, 2022

PSI SD800.433 PEEK IMPLANT

FDA Adverse Event
Injury ·SYNTHES BRANDYWINE·Product code GXN·May 9, 2013

ANIMAS INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·May 25, 2011

TALENT THORACIC STENT GRAFT SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC CARDIOVASCULAR·Product code MIH·August 7, 2008

CPS TIB SPINDLE LT 12X37X42MM

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code KWA·September 16, 2019

Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410. Model Number: WA91307C. The ESG-410 Electrosurgical Generator is an electrosurgical generator which utilizes monopolar and bipolar high frequency current and supports ultrasonic instruments during open surgery, laparoscopic surgery, including single-site surgery, and endoscopic surgery.

FDA Enforcement
Class II ·Ongoing·Olympus Corporation of the Americas·August 27, 2025

HA FlexTrak-Patient transport functionality to transport the patient from the preparation area to the MR system, Product Number: 989710006411

FDA Enforcement
Class II ·Ongoing·Philips North America Llc·June 12, 2024

VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

INGENIO DR EL (pacemakers), Model Numbers: a) J174 b) J177 c) K174 (added 7/15/2021) d) K184 (added 7/15/2021) e) K187 (added 7/15/2021)

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

INVIVE CRT-P, Model Numbers: a) V172 b) V173 c) V182 d) V183 e) W172 f) W173

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

ADVANTIO DR EL (pacemaker), Model Numbers: a) J064 b) J067 c) K064 (added 7/15/2021) d) K084 (added 7/15/2021) e) K087 (added 7/15/2021)

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

VISIONIST CRT-P pacemaker, Models: a) U225 b) U226 c) U228

FDA Enforcement
Class II ·Ongoing·Boston Scientific Corporation·July 14, 2021