17 results · 35ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

HYGIA HEALTH SERVICES REPROCESSED NELLCOT D-25 OXISENSOR II

FDA 510(k)
FDA Class 2 ·Cardiovascular

Lumbar Interbody Fusion System (OLLIF)

FDA UDI
ADVANCED RESEARCH MEDICAL LLC·00850014575120·Lumbar Interbody Fusion System (OLLIF) Oblique ...

Cosmolock

FDA UDI
Kalitec Direct LLC·B07311K0120150·Assembly, Screwdriver, Polyaxial, Lockable

STEVE MADDEN

FDA UDI
FGX INTERNATIONAL INC.·00193033440476·

True Position® Spacer System

FDA UDI
Spine Wave, Inc.·10840642107555·Implant, Lordotic, 27 (L) x 15 (H) mm, 7°

True Position®

FDA UDI
ATLAS SPINE, INC.·M68112080127150·27mm x 15mm Lordotic Spacer

ECAT PET SCANNER

FDA 510(k)
FDA Class 2 ·Radiology

AL-40

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

PNEUPAC PARAPAC VENTILATOR

FDA Adverse Event
Malfunction ·Product code BTL·December 30, 2019

STEM: AMISTEM C CEMENTED STD SIZE 0

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·November 7, 2021

TOTALCARE BED

FDA Adverse Event
Malfunction ·HILL-ROM, INC.·Product code FNL·February 22, 2013

ASR UNI FEMORAL IMPL SIZE 43

FDA Adverse Event
Injury ·DEPUY INTL LTD·Product code KWA·February 24, 2011

PROGRAMMING WAND

FDA Adverse Event
Malfunction ·CYBERONICS, INC.·Product code LYJ·March 11, 2008

ON-Q C-BLOC 400ML, 2-14ML/HR SELECT-A-FLOW

FDA Adverse Event
Injury ·HALYARD - IRVINE·Product code MEB·April 17, 2015

Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER

FDA Enforcement
Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026

Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·June 29, 2022

CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024