19 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MectaLIF Extension
FDA 510(k)
FDA Class 2
·Orthopedic
BIO PORTADUR, ORDER-NO.:2017
FDA 510(k)
FDA Class 2
·Dental
PLEURX PLEURAL CATHETER SYSTEMS
FDA 510(k)
FDA Class 2
·Cardiovascular
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
ANTHEM CRT
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC. CRMD·Product code DXY·January 13, 2014
N/A
FDA Adverse Event
Malfunction
·STRYKER SUSTAINABILITY SOLUTIONS·Product code HRX·August 16, 2011
GYNECARE TVT OBURATOR SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·July 9, 2013
FLAT TITANIUM PECTUS BAR 11IN
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 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
TI PANGEA(TM) LOCKING CAP
FDA Adverse Event
Injury
·SYNTHES BRANDYWINE·Product code NKB·August 19, 2015
6.0MM TI HARD ROD 125MM
FDA Adverse Event
Injury
·SYNTHES BRANDYWINE·Product code NKB·August 19, 2015
6.0MM TI PANGEA(TM) POLYAXIAL SCR DUAL CORE/45MM THRD LENGTH
FDA Adverse Event
Injury
·SYNTHES BRANDYWINE·Product code NKB·August 19, 2015
FLAT TITANIUM PECTUS BAR 12.5
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code HRS·January 9, 2025
Allura system; System Code Description (Model Numbers): Allura Xper FD10C (722001), Allura Xper FD10F (722002), Allura Xper FD10 (722003, 722010, 722026), 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), Cardio Vascular-Allura (722400);
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·May 27, 2026