15 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Global Hypoperfusion Index (GHI) Algorithm
FDA 510(k)
FDA Class 2
·Cardiovascular
Unity Total Knee System
FDA UDI
CORIN LTD·05056139233760·Hole Saw Guide
ihcDirect® CEA Ab
FDA UDI
NOVODIAX, INC.·00850000596047·Clone C135
ihcDirect® CEA Ab
FDA UDI
NOVODIAX, INC.·00850000596054·Clone C135
ihcDirect® CEA Ab Conjugate 5mL
FDA UDI
NOVODIAX, INC.·00850030934475·Clone C135
ihcDirect® CEA Ab Conjugate 15mL
FDA UDI
NOVODIAX, INC.·00850030934482·Clone C135
ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
NMI PICC MAXIMAL BARRIER NURSING KITS
FDA 510(k)
FDA Class 2
·General Hospital
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 20, 2025
SEE H10
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code NBC·April 18, 2013
PSX INTERBODY SYSTEM
FDA Adverse Event
Injury
·ALPHATEC SPINE, INC.·Product code MAX·April 29, 2025
ITREL 3
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·October 30, 2008
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 1, 2011
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·July 12, 2013
TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021