9 results
·
18ms
·
Sources: EU EUDAMED, US FDA
ASAHI AM-BIO SERIES DIALYZERS (WET MODELS)& (DRY MODELS), MODELS AM-BIO-50,AM-BIO-65, AM-BIO-75, AND AM-BIO-100, AM-BIO-
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TREND(R) EMERGE(TM) TOXOPLASMA IGG ELISA
FDA 510(k)
FDA Class 2
·Microbiology
OSSEODUO, SHAVER HANDPIECE S80 AND S120, MICROMOTOR 80K
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
PRIMEADVANCED
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·October 16, 2013
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·February 28, 2013
ULTRACISION HARMONIC ACE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·February 10, 2011
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
JUMAO MEDICAL EQUIPMENT·Product code IOR·August 6, 2014
BIOMET MICROFIXATION MANDIBULAR FRACTURE/ RECONSTRUCTION DEVICES
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code HWC·June 3, 2016
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024