14 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Argulated Locking Plates
FDA 510(k)
FDA Class 2
·Dental
E.M Adams co, inc.
FDA UDI
E.M. ADAMS, INC.·10840200301661·SINGLE INSTRUMENT
E.M Adams co, inc.
FDA UDI
E.M. ADAMS, INC.·18100013401661·SINGLE INSTRUMENT
BLAKSTONE LAMINOPLASTY FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
COOLTOUCH
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
IDENTITY ADX XL DR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL INC. CRMD·Product code DXY·January 13, 2014
MICRO SAGITTAL SAW
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code HBE·June 3, 2013
E. WALKER 6MM LT MED FOSSA
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code LZD·June 29, 2011
TECNIS
FDA Adverse Event
Injury
·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code HQL·September 6, 2018
CEPHALOMEDULLARY TARGETING GUIDE STANDARD
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code HSB·April 7, 2023
ZNN¿¢, CMN LAG SCREW, ø 10.5 MM, 115 MM INCLUDING SET SCREW
FDA Adverse Event
Injury
·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code HSB·April 20, 2023
5.0 MM DIAMETER CORTICAL SCREW - RED FIXED ANGLE 3.5 MM HEX HEAD
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code HSB·April 7, 2023
5.0 MM DIAMETER CORTICAL SCREW - RED FIXED ANGLE 3.5 MM HEX HEAD
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code HSB·April 7, 2023
BD FocalPoint Slide Profiler and BD FocalPoint GS Review Station; Catalog Nos. 490398, 490653, 491085, 491086, 491090, 490189 The BD FocalPoint GS Imaging System is intended to assist in cervical cancer screening of BD SurePath Liquid-based Pap Test slides to detect evidence of squamous carcinoma, adenocarcinoma and their usual precursor conditions.
FDA Enforcement
Class III
·Terminated·Becton Dickinson & Co.·October 17, 2018