12 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TECO HOMOCYSTEINE ENZYMATIC ASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SENTECH MEDICAL EXPRESS COMPRESSION SYSTEM (P/N SM800)
FDA 510(k)
FDA Class 2
·Cardiovascular
ENDO-GLIDE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TRESTLE LUXE ANTERIOR CERVICAL PLATING SYSTEM
FDA Adverse Event
Injury
·ALPHATEC SPINE INC·Product code HXX·March 16, 2020
LOGIC TIBIA PS MOD INSRT SZ 2 9MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·June 4, 2024
GYNECARE GYNEMESH* PS
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTO·April 17, 2013
COBAS 6000 E601 MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code CEM·April 20, 2011
INFANT LOW FLOW BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD.·Product code BTT·June 20, 2008
ALINITY I PROCESSING MODULE
FDA Adverse Event
Malfunction
·ABBOTT LABORATORIES·Product code JJE·December 9, 2025
Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018