11 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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COAGUCHEK XS SYSTEM
FDA 510(k)
FDA Class 2
·Hematology
BioQuick®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR70609781·BioQuick-Brackets Roth .018" 200 Brackets 3 w. ...
ANATOMIC TOTAL KNEE PROSTHESIS
FDA 510(k)
FDA Class 2
·Orthopedic
TINA-QUANT ALPHA-1 ANTITRYPSIN
FDA 510(k)
FDA Class 2
·Immunology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 13, 2025
BIOLOX PROSTHESIS HEAD 12/14 28MM S
FDA Adverse Event
Malfunction
·AESCULAP AG & CO. KG·Product code LWJ·April 14, 2014
BIOLOX PROSTHESIS HEAD 12/14 28MM S
FDA Adverse Event
Malfunction
·AESCULAP AG AND CO. KG·Product code LWJ·March 6, 2014
1.5MM MANDIBLE ELEVATED MESH FOOT B-TYPE 5.5MM OFFSET
FDA Adverse Event
Injury
·SYNTHES USA·Product code MQN·April 16, 2013
FINELINE II
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NVN·April 18, 2011
ROCHE COBAS AMPLIPREP INSTRUMENT
FDA Adverse Event
Malfunction
·ROCHE INSTRUMENT CENTER·Product code JQW·June 12, 2008
CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024