21 results
·
23ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
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