683 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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BioSphere MIS Putty (BioSphere MIS)
FDA 510(k)
FDA Class 2
·Orthopedic
inCoris ZI
FDA UDI
SIRONA Dental Systems GmbH·E27661733012·inCoris ZI 65/25 F2 1Stück/pcs.
CENTRONAIL TITANIUM UNIVERSAL FEMORAL NAILING SYSTEM
FDA UDI
ORTHOFIX SRL·18032937167883·SCREW SCALE
FreeStyle LibreLink
FDA UDI
ABBOTT DIABETES CARE INC·00357599000059·FreeStyle LibreLink iOS US
Mini Skirt Crowns
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746039621·CROWN MINI SKIRT LR 1ST MOLAR SZ 8 W/18.5MM CAN...
Mini Skirt Crowns
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746039614·CROWN MINI SKIRT LR 1ST MOLAR SZ 7 W/18.5MM CAN...
Mini Skirt Crowns
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746039591·CROWN MINI SKIRT LR 1ST MOLAR SZ 5 W/18.5MM CAN...
n/a
FDA UDI
Ortho Development Corporation·00822409110889·Locking Cup Impactor Draw Bar
Mini Skirt Crowns
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746039584·CROWN MINI SKIRT LR 1ST MOLAR SZ 4 W/18.5MM CAN...
Mini Skirt Crowns
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746039607·CROWN MINI SKIRT LR 1ST MOLAR SZ 6 W/18.5MM CAN...
CONCENPIECE,HIGH-SPEED HANDPIECE SERIES
FDA 510(k)
FDA Class 1
·Dental
ZOE FLUID STATUS MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
Echotip
FDA UDI
COOK INCORPORATED·00827002163744·Echotip Disposable Lancet Needle
SYMBIQ 3.13 DUAL CHA
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·October 10, 2014
CONTAK RENEWAL
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·July 23, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 17, 2013
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 7, 2025
CERVICAL I/F CAGE LG 7
FDA Adverse Event
Injury
·DEPUY SYNTHES SPINE·Product code MQP·August 23, 2013
FREESTYLE LIBRELINK
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC·Product code PZE·December 5, 2023
V-Twin, Catalog # 6002-800, UDI: 03661540600180 - Product Usage: An in vitro diagnostic device, which is an automated chemistry analyzer, micro type, intended for clinical use in conjunction with certain materials to measure a variety of analytes, including applications in clinical chemistry, monitoring drugs of abuse and in therapeutic drug monitoring.
FDA Enforcement
Class II
·Terminated·Vital Scientific N.V.·October 16, 2019