11 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CITRIC ACID 20% SOLUTION, MODEL 329
FDA 510(k)
FDA Unclassified
·Unknown
Carnegie Surgical LLC
FDA UDI
Carnegie Surgical LLC·G14150637030·BARON (SCHUKNECHT) suction tube 3 FR (1mm), wit...
SANYO CO2 INCUBATORS, MODELS NOS. MCO-17AC, MCO-17AIC, MCO-20AIC,AND MC0-175M
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
TAUT-INSUFFLATION NEEDLE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
BD INSULIN SYRINGE WITH BD ULTRA-FINE NEEDLE
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·December 20, 2019
IAB: 7.5 FR - 40 CC
FDA Adverse Event
Malfunction
·ARROW INTL., INC.·Product code DSP·April 12, 2013
PELVISOFT ACELLULAR COLLAGEN BIOMESH
FDA Adverse Event
Injury
·C.R. BARD, INC.·Product code FTM·April 13, 2011
ADULT BREATHING CIRCUIT, INSPIRATORY HEATED
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD.·Product code BTT·June 20, 2008
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
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