19 results
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Grosz Play Feel
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
PMT® Halo Systems
FDA UDI
PMT CORPORATION·00650551111139·HALO, 1203-5 VEST PED3, LAMBSWOOL LINER, 1211-1...
Savant Lumbar Interbody Fusion System
FDA UDI
CURITEVA, INC.·B648C41432110880·Titanium TLIF Spacer, 32 x 11 x 8mm, 8 deg
Savant Lumbar Interbody Fusion System
FDA UDI
CURITEVA, INC.·B648C40432110880·PEEK TLIF Spacer, 32 x 11 x 8mm, 8 deg
BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·April 7, 2021
1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, AIM Laparoscopes
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SIII ALARM AMPLIFIER
FDA 510(k)
FDA Class 2
·Cardiovascular
EASYPOINT NEEDLE
FDA Adverse Event
Injury
·RETRACTABLE TECHNOLOGIES, INC.·Product code FMI·February 9, 2023
EASYPOINT NEEDLE
FDA Adverse Event
Injury
·RETRACTABLE TECHNOLOGIES, INC.·Product code FMI·February 9, 2023
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR REDWOODY CITY·Product code MGB·October 24, 2008
LEAD MODEL UNKNOWN
FDA Adverse Event
Malfunction
·CYBERONICS INC·Product code LYJ·August 5, 2011
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·July 8, 2013
TEOSYAL RHA 3
FDA Adverse Event
Injury
·TEOXANE SA·Product code LMH·December 20, 2022
ACUSON S2000 and ACUSON S3000 ultrasound systems with the Virtual Touch IQ option; Model numbers: 10041461, 10440017 -S2000 system 10441730 -S3000 system VTIQ Option- 10439521 and 10439522 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
Philips Interventional Hemodynamic Application R.1.2X, R.1.3.0, R1.2.1. Software that enables invasive investigation of cardiac and vascular diseases.
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·June 5, 2024
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
Veradius Unity with Software Release 2.1- Amobile, diagnostic X-ray imaging and viewing system. . Model Number: 718132
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 15, 2021
Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020
FDA Enforcement
Class II
·Terminated·Cardinal Health 200, LLC·February 26, 2020
Allura system; System Code Description (Model Numbers): Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10 OR Table (722022, 722033), Allura Xper FD10/10 (722005, 722011, 722027), Allura Xper FD20 (722006, 722012, 722028), Allura Xper FD20 Biplane (722008, 722013), Allura Xper FD20 OR Table (722015, 722023, 722035), Allura Xper FD20 Biplane OR Table (722025), Allura Xper FD20/10 (722029), Allura Xper FD20/15 (722058), Allura Xper FD20/15 OR Table (722059), Allura Xper FD20/20 (722038), Allura Xper FD20/20 OR Table (722039);
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·June 3, 2026