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