12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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A-V FOOT PUMP
FDA 510(k)
FDA Class 2
·Cardiovascular
Bone cutters
FDA UDI
DFS - DIAMON GmbH·04057176162052·Carb. bone cutr. HP 1,8 mm
Diversatek Healthcare
FDA UDI
DIVERSATEK HEALTHCARE, INC.·M7831217180·Gastric Sump Tube, 18 French
GRIPTION
FDA UDI
DEPUY (IRELAND)·10603295381327·GRIPTION TF SCREW 5.5mm x 18mm
BELIFU
FDA Adverse Event
Injury
·HONG QIANGXING (SHEN ZHEN) ELECTRONICS LIMITED·Product code GZJ·February 10, 2020
OSSEOCONDUCT
FDA 510(k)
FDA Class 2
·Dental
INTRAORAL IMAGING SYSTEM, MODEL SUNI-RAY
FDA 510(k)
FDA Class 2
·Dental
BAERVELDT SHUNT
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code KYF·February 12, 2016
SERVO-I
FDA Adverse Event
Malfunction
·MAQUET CRITICAL CARE AB·Product code CBK·May 14, 2013
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·September 26, 2014
5FX55CM DL PRO PICC CT
FDA Adverse Event
Malfunction
·MEDCOMP·Product code LJS·May 19, 2011
Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024