19 results · 23ms · Sources: EU EUDAMED, 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