14 results · 29ms · Sources: EU EUDAMED, US FDA

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LATEX PATIENT EXAMINATION GLOVES

FDA 510(k)
FDA Class 1 ·General Hospital

SCHACHNER-OVIL RAPITRAC PERCUTAN. TRACHEOSTOMY KIT

FDA 510(k)
FDA Class 2 ·Anesthesiology

BILE ESCULIN AZIDE AGAR

FDA 510(k)
FDA Class 1 ·Microbiology

1.5MM SYSTEM TWIST DRILL WITH J NOTCH 1.1 X 50MM, 9MM STOP

FDA Adverse Event
Malfunction ·BIOMET MICROFIXATION·Product code HBE·June 17, 2020

TW DRILL 1.1X50MM 9MMSTOP W/NT

FDA Adverse Event
Malfunction ·BIOMET MICROFIXATION·Product code HBE·May 5, 2021

TW DRILL 1.1X50MM 9MMSTOP W/NT

FDA Adverse Event
Malfunction ·BIOMET MICROFIXATION·Product code HBE·May 5, 2021

TW DRILL 1.1X50MM 9MMSTOP W/NT

FDA Adverse Event
Malfunction ·BIOMET MICROFIXATION·Product code HBE·February 17, 2021

SYMBIQ FRENCH SINGLE

FDA Adverse Event
Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·April 25, 2014

THINLINE

FDA Adverse Event
Injury ·GUIDANT ANGLETON/ST. PAUL·Product code NVN·November 9, 2010

E360 VENTILLATOR

FDA Adverse Event
Malfunction ·NEWPORT MEDICAL INSTRUMENTS, INC.·Product code CBK·December 27, 2012

TW DRILL 1.1X50MM 9MMSTOP W/NT

FDA Adverse Event
Malfunction ·BIOMET MICROFIXATION·Product code HBE·November 29, 2021

LACTOSORB SYSTEM 1.5MM ADJUSTABLE SELF-DRILLING TAP

FDA Adverse Event
Malfunction ·BIOMET MICROFIXATION·Product code HWX·June 17, 2020

GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION CONSTRAINED LINER 28MM ID GROUP 1, REF 134-28-41 b. NOVATION CONSTRAINED LINER 32MM ID GROUP 2, REF 134-32-42 c. NOVATION CONSTRAINED LINER 36MM ID GROUP 3, REF 134-36-43 d. NOVATION CONSTRAINED LINER 36MM ID GROUP 4, REF 134-36-44 e. NOVATION CONSTRAINED LINER 36MM ID GROUP 5, REF 134-36-45

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·September 21, 2022

Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system

FDA Enforcement
Class I ·Terminated·CareFusion 303, Inc.·August 12, 2020