23 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
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