9 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BAND AID* ADHESIVE BANDAGES
FDA 510(k)
FDA Class 1
·General Hospital
n.a.
FDA UDI
Karl Storz GmbH & Co. KG·04048551198995·Indirect Laryngeal Forceps, 17 cm
Symmetry Bunnell
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482048504·Symmetry® Stripper, Bunnell Tendon, Round, 3.0 ...
Lympha Press Optimal Plus
FDA 510(k)
FDA Class 2
·Cardiovascular
HUMAN REFERENCE SERUM C4 COMPLEMENT
FDA 510(k)
FDA Class 2
·Immunology
RESTORE SENSOR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·April 30, 2014
2800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·October 5, 2012
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 19, 2015
OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021