23 results
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31ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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AIA-1200DX - AUTOMATED ENZYME IMMUNOASSAY SYSTEM
FDA 510(k)
FDA Class 1
·Clinical Chemistry
PROFYLE
FDA UDI
Stryker GmbH·34546540244971·BONE SCREWS, CROSS-FIT, SELF-TAPPING
Instrument Case
FDA UDI
KATENA PRODUCTS, INC.·00841668113189·STERILIZING CASE SMALL KATENA IOP
MODIFICATION TO SMITH & NEPHEW TWINFIX TI QUICK T
FDA 510(k)
FDA Class 2
·Orthopedic
BIOPLEX 2200 EBV IGM KIT
FDA 510(k)
FDA Class 1
·Microbiology
Titan™ Total Shoulder System
FDA UDI
Ascension Orthopedics, Inc.·10381780123231·The Titan Modular Total Shoulder fracture body ...
Titan Modular Shoulder System 2.5
FDA UDI
Smith & Nephew, Inc.·00885556859483·TSS FRACTURE BODY. 2.5 08SML
Titan™ Total Shoulder System
FDA UDI
Ascension Orthopedics, Inc.·10381780123255·The Titan Modular Total Shoulder fracture body ...
Titan Modular Shoulder System 2.5
FDA UDI
Smith & Nephew, Inc.·00885556859490·TSS FRACTURE BODY. 2.5 08STD
Titan™ Total Shoulder System
FDA UDI
Ascension Orthopedics, Inc.·10381780123248·The Titan Modular Total Shoulder fracture body ...
Titan™
FDA UDI
Ascension Orthopedics, Inc.·10381780235835·The Fracture Body Trial is used to evaluate the...
Titan™
FDA UDI
Ascension Orthopedics, Inc.·10381780235828·The Fracture Body Trial is used to evaluate the...
Titan Modular Shoulder System 2.5
FDA UDI
Smith & Nephew, Inc.·00885556863350·TSS FRACTURE BODY TRIAL SML. 2.5
Titan Modular Shoulder System 2.5
FDA UDI
Smith & Nephew, Inc.·00885556859476·TSS FRACTURE BODY. 2.5 08LRG
Titan Modular Shoulder System 2.5
FDA UDI
Smith & Nephew, Inc.·00885556863367·TSS FRACTURE BODY TRIAL STD. 2.5
Titan™
FDA UDI
Ascension Orthopedics, Inc.·10381780235811·The Fracture Body Trial is used to evaluate the...
Titan Modular Shoulder System 2.5
FDA UDI
Smith & Nephew, Inc.·00885556863343·TSS FRACTURE BODY TRIAL LRG. 2.5
METRX SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code HRX·June 10, 2024
CAPSURE SENSE
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·December 13, 2010
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·July 9, 2014