29 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NMI DIALYSIS CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PIVOX™ Oblique Lateral Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169604971·SPACER 2131260 OLIF25 27MM 6 DEG 10X60
NC Multi-base Abutment
FDA UDI
BIO CONCEPT Co., Ltd.·06947600305989·
Biogel
FDA UDI
Bosma Enterprises·10818634023657·Biogel Indicator Underglove Surgical 6.0 - 50 P...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197205290·SAUERBRUCH rib shear 26 cm
Vu aPod™ - L
FDA UDI
Seaspine Orthopedics Corporation·10889981046064·LATERAL IMPLANT, ANGLED SPINPLATE™, 12mm X 60mm
A/C ENZYMATIC VITAMIN B6 ASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM, FREESTYLE TRACKER DIABETES MANAGEMENT SYSTEM, MODELS 11001, 16000, AND 16005
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BIM400 IMPLANT MAGNET
FDA Adverse Event
Injury
·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code LXB·December 19, 2017
COCHLEAR BAHA ATTACT SYSTEM
FDA Adverse Event
Injury
·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code LXB·June 26, 2016
T:SLIM G5 SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code OYC·August 1, 2019
COOK® CERVICAL RIPENING BALLOON
FDA Adverse Event
Malfunction
·COOK INC·Product code PFJ·July 18, 2016
ATTRACT SYSTEM
FDA Adverse Event
Injury
·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code LXB·October 15, 2015
COCHLEAR BAHA ATTACT SYSTEM
FDA Adverse Event
Injury
·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code LXB·August 17, 2016
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 28, 2025
BIM400 IMPLANT MAGNET
FDA Adverse Event
Injury
·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code LXB·August 17, 2016
SP MAGNET 3
FDA Adverse Event
Injury
·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code LXB·September 13, 2016
COCHLEAR BAHA ATTRACT SYSTEM
FDA Adverse Event
Injury
·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code LXB·August 14, 2016
BIM400 IMPLANT MAGNET
FDA Adverse Event
Injury
·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code LXB·October 8, 2025
COOK® CERVICAL RIPENING BALLOON
FDA Adverse Event
Malfunction
·COOK INC·Product code PFJ·July 19, 2016