23 results · 19ms · Sources: EU EUDAMED, US FDA

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3Delta Denture Base - 3Delta Denture Bond - 3Delta Denture Fix

FDA 510(k)
FDA Class 2 ·Dental

Bernafon

FDA UDI
Bernafon AG·05711584114421·CO9 B 105, 2.4G NFM MAC CAPTO 9 GPL

Z FLEX-270TM STEERABLE SHEATH

FDA 510(k)
FDA Class 2 ·Cardiovascular

MODIFICATION TO:FASTIX THC/COC DRUG SCREEN DIPSTICK TEST, FASTIX THC/COC/MET DRUG SCREEN DIPSTICK TEST, FASTIX OPI/MET

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

FLAT TITANIUM PECTUS BAR 10.5

FDA Adverse Event
Injury ·BIOMET MICROFIXATION·Product code HRS·March 12, 2025

FLAT TITANIUM PECTUS BAR 12

FDA Adverse Event
Injury ·BIOMET MICROFIXATION·Product code HRS·March 12, 2025

CYPHER SIROLIMUS-ELUTING CORONARY STENT

FDA Adverse Event
Injury ·CORDIS LLC (PR)·Product code NIQ·October 27, 2008

REPLACEMENT HEART VALVE

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES·Product code DYE·August 16, 2011

COGNIS

FDA Adverse Event
Injury ·GUIDANT CRM CLONMEL IRELAND·Product code NIK·July 9, 2013

FLAT TITANIUM PECTUS BAR 11IN

FDA Adverse Event
Injury ·BIOMET MICROFIXATION·Product code HRS·March 12, 2025

QUATERA 700 BIMANUAL I/A HANDPIECE SET

FDA Adverse Event
Injury ·CARL ZEISS MEDITEC AG (OBERKOCHEN)·Product code FSO·September 8, 2023

FLAT TITANIUM PECTUS BAR 13IN

FDA Adverse Event
Injury ·BIOMET MICROFIXATION·Product code HRS·March 12, 2025

FLAT TITANIUM PECTUS BAR 13IN

FDA Adverse Event
Injury ·BIOMET MICROFIXATION·Product code HRS·March 12, 2025

FLAT TITANIUM PECTUS BAR 11IN

FDA Adverse Event
Injury ·BIOMET MICROFIXATION·Product code HRS·January 9, 2025

FLAT TITANIUM PECTUS BAR 11IN

FDA Adverse Event
Injury ·BIOMET MICROFIXATION·Product code HRS·January 9, 2025

FLAT TITANIUM PECTUS BAR 11IN

FDA Adverse Event
Injury ·BIOMET MICROFIXATION·Product code HRS·January 9, 2025

COBAS® WNV NUCLEIC ACID TEST FOR USE ON THE COBAS® 6800/8800 SYSTEMS

FDA Adverse Event
Malfunction ·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code QHO·September 19, 2025

FLAT TITANIUM PECTUS BAR 12.5

FDA Adverse Event
Injury ·BIOMET MICROFIXATION·Product code HRS·January 9, 2025

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

Philips Zenition 70, Model Number: 718133

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·November 20, 2024