12 results
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23ms
·
Sources: EU EUDAMED, US FDA
Sterile Latex Surgical Gloves Powder Free
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
STRYKER SPINE POWER ADAPTOR (ACCESSORY INSTRUMENT)
FDA 510(k)
FDA Class 2
·Orthopedic
I-STAT SYSTEM
FDA 510(k)
FDA Class 1
·Clinical Chemistry
PANEL PHOENIX NMIC/ID-481
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·December 15, 2025
CONTEGRA PULMONARY VALVED CONDUIT - SUPPORTED
FDA Adverse Event
Death
·MEDTRONIC HEART VALVES DIVISION·Product code MWH·October 29, 2014
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·August 15, 2011
GYNECARE TVT OBURATOR SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·July 8, 2013
BD ULTRA-FINE¿ MINI PEN NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMI·January 5, 2022
ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017 S 2000 system 10441730 S 3000 system 10441701 S 1000 system Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·August 5, 2015
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
BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 15, 2021