18 results
·
30ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
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