14 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM
FDA 510(k)
FDA Class 2
·Hematology
Tiger Supply Inc.
FDA UDI
TIGER SUPPLY, INC.·D82360817191·VPS Impression Material Monophase Body Fast Set...
Q-LUX PLASMA 100 LIGHT CURE UNIT
FDA 510(k)
FDA Class 2
·Dental
PLUS CANCELLOUS BONE SCREWS
FDA 510(k)
FDA Class 2
·Orthopedic
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 8, 2024
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·April 29, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 9, 2011
EEA XL 31MM SINGLE-USE STAPLER
FDA Adverse Event
Injury
·NORTH HAVEN - USS·Product code GDW·July 25, 2008
HOSP SS FLEXX METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·February 22, 2011
GORE® TRI-LOBE BALLOON CATHETER
FDA Adverse Event
Injury
·W. L. GORE & ASSOCIATES, INC.·Product code DQY·February 24, 2021
HOSP SS FLEXX METER W/O LASER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·May 17, 2011
HOSP SS FLEXX METER
FDA Adverse Event
Death
·LIFESCAN INC.·Product code NBW·April 1, 2011
Allura Xper FD20 Product Codes: (1)722012, (2) 722028, (3) 722006; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 1, 2025
cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014