14 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ESU-1 Electrosurgical Generator
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ANSWER / IMPACT / INTEGRAL HIP SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304253162·
SYNTHES DENTOALVEOLAR BONE FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Dental
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLOR
FDA 510(k)
FDA Class 1
·General Hospital
ENDO II HEAD
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWL·March 10, 2017
ENDO II TAPER INSERT
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWL·March 10, 2017
INTEGRAL CENTRALIZER FEMORAL
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JDG·May 26, 2017
ECHO FX 7MM STD FEMORAL
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·August 29, 2019
CONSULTA CRT-D
FDA Adverse Event
Malfunction
·IPG MFG SWITZERLAND·Product code NIK·October 10, 2014
COAGUCHEK ® XS SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code GJS·June 11, 2013
FINELINE II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·July 14, 2011
10MM/130 DEG TI CANN TROCH FIXATION NAIL 380MM/LEFT-STER
FDA Adverse Event
Injury
·WRIGHTS LANE: SYNTHES USA PRODUCTS LLC·Product code HSB·January 9, 2018
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·April 14, 2015
OPTETRAK Three Peg Patella, Item Numbers: a) 200-02-26, 26MM; b) 200-02-29, 29MM; c) 200-02-32, 32MM; d) 200-02-35, 35MM; e) 200-02-38, 38MM; f) 200-02-41, 41MM;
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·June 26, 2024