27 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MI VARNISH
FDA 510(k)
FDA Class 2
·Dental
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772814527·GENUMEDI SAND SIZE I
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772814534·GENUMEDI SAND SIZE II
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04064984699427·GENUMEDI SILVER SIZE VIII
Plateau Spacer System
FDA UDI
Life Spine, Inc.·00190837026745·PLATEAU Interbody, Curved, Bulleted, 11mm 28mm ...
ANA 2000 NON GAMMA 2 EXTRA HIGH COPPER DENTAL ALLOY
FDA 510(k)
FDA Class 2
·Dental
SHAPELOC-CL (CRUCIATE LIGAMENT) SOFT TISSIE FASTNER, SHAPELOC-ST (TENODESIS) SOFT TISSUE FASTNER
FDA 510(k)
FDA Class 2
·Orthopedic
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code NKB·May 1, 2014
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 2, 2024
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·October 2, 2012
INFINITI VISION SYSTEM
FDA Adverse Event
Malfunction
·ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER·Product code HQC·January 3, 2018
STEM: AMISTEM H HA COATED STD STEM SIZE 3
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·July 11, 2024
AMISTEM H FEMORAL STEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL, SA·Product code KWY·June 5, 2013
GLIDESHEATH SLENDER NITINOL (CONVENIENCE KIT)
FDA Adverse Event
Malfunction
·TERUMO MEDICAL CORPORATION·Product code DYB·February 21, 2018
FOXCROSS PTA CATHETER
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code LIT·May 9, 2013
SUMMIT UNIVERSAL BROACH HANDLE
FDA Adverse Event
Malfunction
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code LXH·September 19, 2014
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE·Product code KDJ·May 25, 2011
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code NKB·May 25, 2016
GLIDESHEATH SLENDER NITINOL (CONVENIENCE KIT)
FDA Adverse Event
Malfunction
·TERUMO MEDICAL CORPORATION·Product code DYB·December 16, 2019
ESG-410 Electrosurgical Generator- In conjunction with electrosurgical accessories intended for cutting and coagulation of tissue in open, laparoscopic , and endoscopic surgeries Model/Catalog Number: WA91307C
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·July 31, 2024