15 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CD HORIZON Spinal System
FDA 510(k)
FDA Class 2
·Orthopedic
MAT PL,BR HYDR/ELEC,BLUE,4x7',21-31"
FDA UDI
Hausmann Enterprises, LLC·00840314801036·
MAT PL,BR HYDR/ELEC,GREEN,4X7',21-31"
FDA UDI
Hausmann Enterprises, LLC·00840314801050·
MAT PL,BR HYDR/ELEC,GRAY,4X7',21-31"
FDA UDI
Hausmann Enterprises, LLC·00840314801043·
MAT PL,BR HYDR/ELEC,BLK,4X7',21-31"
FDA UDI
Hausmann Enterprises, LLC·00840314801067·
DISPOSABLE ENDOMETRIAL SUCTION CURETTE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
SYSTEMP.CEM
FDA 510(k)
FDA Class 2
·Dental
OTIS SCREW
FDA Adverse Event
Injury
·S.B.M. SAS·Product code HWC·April 11, 2019
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 17, 2024
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 6, 2025
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 3, 2013
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·September 30, 2014
CROSSLINK ANCHOR PG GLENOID 44
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code KWS·June 23, 2011
GMK SPHERE TIBIAL INSERT
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·August 2, 2017
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022