11 results
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33ms
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Sources: EU EUDAMED, US FDA
SPORICIDIN BRAND DISINFECT TOWEL, SPRAY/SOLUT MODI
FDA 510(k)
FDA Class 1
·General Hospital
LOGIQ
FDA UDI
GE Ultrasound Korea Ltd.·00195278664600·LOGIQ Totus
Gender Solutions®
FDA UDI
Zimmer, Inc.·00889024205864·
Gender Solutions®
FDA UDI
Zimmer, Inc.·00889024205857·
UNI-DOSE SYRINGE PUMP
FDA 510(k)
FDA Class 2
·General Hospital
DW 215-12A ALLOY FOR FORCELAIN FUSED TO METAL
FDA 510(k)
FDA Class 2
·Dental
PATELLO-FEMORAL JOINT SYSTEM GENDER SOLUTIONS PATELLO-FEMORAL¿ Osteoarthritis, traumatic arthritis, polyarthritis, and/or severe chondrocalcinosis of the patellofemoral joint.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·March 21, 2018
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 23, 2013
ATTAIN STARFIX
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·December 14, 2010
TENDRIL STS
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code NVN·July 10, 2014
Gender PFJ FEMORAL COMP, prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer various sizes " Osteoarthritis, traumatic arthritis, polyarthritis, and/or severe chondrocalcinosis of the patellofemoral joint. The salvage of previously failed surgical attempts (e.g., arthroscopy, lateral release, cartilage transplantation). History of patellar dislocation or patella fracture. Dysplasia-induced degeneration. This device is intended for cemented use only."
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·March 2, 2016