12 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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LOQTEQ Distal Fibula Plate 3.5, Cancellous Screw 4.0, Washer
FDA 510(k)
FDA Class 2
·Orthopedic
OsteoMed
FDA UDI
OSTEOMED LLC·00842528103913·2.8 mm/4.8 mm Guide Wire and Drill Guide
REAMER SHAFT, AO FITTING ?8,0X448 MM
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS KIEL·Product code LXH·December 7, 2011
DIMENSION VISTA CHEMISTRY 2 CALIBRATOR (CHEM 2 CAL, KC120)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MODIFICATION TO: CG-6108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR, MODEL FG-00084
FDA 510(k)
FDA Class 2
·Cardiovascular
BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code JKA·January 5, 2023
BD NEXIVA CLOSED IV ACCESS SYSTEM
FDA Adverse Event
Injury
·BECTON DICKINSON INFUSION THERAPY SYSTEMS·Product code FOZ·July 8, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 11, 2013
FLO-GARD 6201 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FRN·September 17, 2008
SOEHENDRA STENT RETRIEVER
FDA Adverse Event
Injury
·COOK ENDOSCOPY·Product code FGE·September 26, 2017
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
OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021