14 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MOTECH TITANIUM SURGICAL MESH
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
3M™ ACE™ Brand
FDA UDI
3M Company·30051131216212·ACE™ Kinesiology Elbow Support 900138, .87 in x...
ROC Crown 6UR
FDA UDI
SPECIALTY APPLIANCES, LLC·D8199001380·
Biopsy Handy
FDA UDI
SOMATEX Medical Technologies GmbH·04250195601926·
Young Specialties
FDA UDI
Young Innovations, Inc.·00840326416563·Comfort Hook™ First Molar Weldable Convertible ...
CONLIN MOLAR BAND
FDA UDI
Ortho Arch Company Inc·D90990013818·MOLAR BAND CONLIN RX LOWER RIGHT 32.5
Neuro Kinetics, Inc. (NKI) I-Portal¿ NOTC system with the OVAR research test; a rotary chair system used in vestibular and neuro-otologic diagnostic testing. This device provides no diagnoses nor does it provide diagnostic recommendations.The OVAR test has not yet been cleared by the FDA, and until then can only be used as an investigational device.
FDA Enforcement
Class II
·Terminated·Neuro Kinetics, Inc.·September 9, 2015
Niceloop TT
FDA UDI
RIVERPOINT MEDICAL, LLC·00810020089943·Suture Tape Loop
MOBILECARE MONITOR, MODEL 2100
FDA 510(k)
FDA Class 1
·General Hospital
MIDAS TOUCH NITRILE EXAMINATION GLOVES-POWDERFREE
FDA 510(k)
FDA Class 1
·General Hospital
OVAL MESH, DIA./HGT. UNK
FDA Adverse Event
Injury
·DEPUY MOTECH, INC.·Product code JDN·October 28, 1999
DUAL EXTENSION
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·May 28, 2014
FUSION OMNI-TOME SPHINCTEROTOME
FDA Adverse Event
Malfunction
·COOK ENDOSCOPY·Product code KNS·October 22, 2010
SERFAS ENERGY SUPER 90-S
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY PUERTO RICO·Product code GEI·December 27, 2012