13 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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Powder Free Nitrile Examination Glove 3.5, Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
FDA 510(k)
FDA Class 1
·General Hospital
LAG FASTENER COUPLER
FDA UDI
Osteocentric Technologies, Inc.·00810189110496·LAG FASTENER COUPLER
Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
FDA Pre-Market Approval
FDA Class 3
·Atellica IM Total PSA II (tPSAII)
SHUNTCHECK (PROMETHEUS 1)
FDA 510(k)
FDA Class 2
·Neurology
TI-OSS
FDA 510(k)
FDA Class 2
·Dental
Widex
FDA UDI
Widex A/S·05706069691221·Widex BEYOND B-F2 (Warm beige ) 440, Telecoil, ...
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 28, 2025
KIT IMPLANTABLE SLIM TIP LEAD, 50CM
FDA Adverse Event
Injury
·ABBOTT MEDICAL·Product code PMP·October 27, 2025
MECHANICAL WALKER, ROLLATOR
FDA Adverse Event
KENSTONE METAL·Product code ITJ·November 10, 2014
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 8, 2011
INCEPTA
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 22, 2013
Surgical Tubing Pack, Model: AMO Prestige Pack, Product Code OPO40
FDA Recall
Terminated
·Allergan Medical Optics Inc·Product code HQC·March 29, 2004
PT Link Waterbath, Model#PT100. Lab Vision PT Module Plus provides an automated standarized alternative to labor intensive and time consuming dewaxing and epitote retrieval procedures.
FDA Recall
Terminated
·Dako North America Inc.·Product code IDY·May 1, 2008