15 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LED Curing Light (C01-X, C02-X)
FDA 510(k)
FDA Class 2
·Dental
Value Toothbrush
FDA UDI
SAFCO DENTAL SUPPLY CO.·10810063755857·Value Toothbrush, imprinted, adult and junior, ...
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690192749·Modular Tibia Stemmed Keel Drill 13mm
Ophthalmic Knife
FDA UDI
KATENA PRODUCTS, INC.·00841668101254·CASTROVIEJO BLADE BREAKER
Neurovascular Liquid Embolic Agent
FDA Pre-Market Approval
FDA Class 3
·SQUID Liquid Embolic Agent (LEA)
Plateau-X Spacer System
FDA UDI
Life Spine, Inc.·00190837012694·
Plateau-X Spacer System
FDA UDI
Life Spine, Inc.·00190837012656·
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197059282·NABATOFF Stripper head
D: 9 mm
Adaptive Biotechnologies clonoSEQ Assay
FDA 510(k)
FDA Class 2
·Pathology
Baide
FDA 510(k)
FDA Class 2
·Orthopedic
SYRINGE 10ML SALINE FILL CHINA SP
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code NGT·March 19, 2025
ACCU-CHEK SPIRIT
FDA Adverse Event
Malfunction
·DISETRONIC MEDICAL SYSTEMS, INC.·Product code LZG·November 14, 2008
GYNECARE X-TRACT MORCELLATOR
FDA Adverse Event
Malfunction
·ETHICON·Product code HET·September 15, 2011
ARTICULEZE M HEAD 36MM -2
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code JDI·July 26, 2013
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 23, 2013