18 results · 30ms · 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.

Leaseir MHR Xcell

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

PMT® Halo Systems

FDA UDI
PMT CORPORATION·00650551113935·HALO, CTLSO VEST SMALL, COOLMAX LINER, 1211-1 X...

HAWKEYE™ Vertebral Body Replacement (VBR)

FDA UDI
Choice Spine, LP·00840996101080·VBR,SPACER,12X14X49,0 DEG

LVIS

FDA UDI
Microvention, Inc.·00811425029992·Stent

LVIS

FDA UDI
Microvention, Inc.·00810170016349·Stent

LVIS

FDA UDI
Microvention, Inc.·00812636022246·Stent

LVIS

FDA UDI
Microvention, Inc.·00810170019043·Stent

LVIS

FDA UDI
Microvention, Inc.·00842429100981·Stent

EPOCA CODR STEM AND HEAD

FDA 510(k)
FDA Class 2 ·Orthopedic

DEEPVIEW DIGITAL VIDEO PHYSIOLOGICAL PORTABLE IMAGING SYSTEM

FDA 510(k)
FDA Class 2 ·Cardiovascular

BD RAPID DETECTION OF SARS-COV-2 VERITOR

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code QKP·January 19, 2021

HEARTSTREAM XL

FDA Adverse Event
Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·October 23, 2008

COLLEAGUE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 17, 2011

LIGACLIP** ENDOSCOPIC CLIP APPLIER

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·July 9, 2013

BD RAPID DETECTION OF SARS-COV-2 VERITOR

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code QKP·November 12, 2020

UROSKOP Omnia Max. Model Number: 10762473

FDA Enforcement
Class II ·Ongoing·Siemens Medical Solutions USA, Inc·June 25, 2025

Direct Drive Clip Applier CA090, indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures. Distributed individually and in kits.

FDA Enforcement
Class II ·Terminated·Applied Medical Resources Corp·May 18, 2016

18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer  10041227 & 10789400 S1000  10441701 S2000  10041461 S2000 (Refurb) - 10440017 S3000  10441730 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.·May 3, 2017