9 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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TUM-E-VAC BITE BLOCK
FDA 510(k)
FDA Class 2
·Neurology
Bosworth Original Truliner
FDA UDI
Harry J Bosworth Company·H66809219461·Orig Truliner Liquid
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471123793·K-WIRE - DOUBLE TROCAR 1.4mm DIA x 150mm
CELL ROBOTICS ULTRA-LIGHT PEEL LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
AXIS-SHIELD ACVTIVE-B12
FDA 510(k)
FDA Class 2
·Clinical Chemistry
TRIAGE TOX DRUG SCREEN W/MTD
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO INC·Product code DJR·May 28, 2014
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·January 4, 2013
ACCURUS 400VS
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·December 8, 2010
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS, REF 130-32-51 b. NOVATION GXL LINER NEUTRAL, 36MM ID, GROUP 2 CUPS, REF 130-36-52 c. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 3 CUPS, REF 130-40-53 d. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 4 CUPS, REF 130-40-54 e. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 5 CUPS, REF 130-40-55 f. NOVATION GXL LINER LIPPED 32MM ID, GROUP 1 CUPS, REF 132-32-51 g. NOVATION GXL LINER LIPPED 36MM ID GROUP 2, REF 132-36-52 h. NOVATION GXL LINER LIPPED 40MM ID, GROUP 3 CUPS, REF 132-40-53 i. NOVATION GXL LINER LIPPED 40MM ID, GROUP 4 CUPS, REF 132-40-54 j. NOVATION GXL LINER LIPPED 40MM ID, GROUP 5 CUPS, REF 132-40-55 k. NOVATION GXL LINER +5 LAT 40MM GROUP 3 CUPS, REF 136-40-53 l. NOVATION GXL LINER +5 LAT 40MM ID GROUP 4 CUPS, REF 136-40-54 m. NOVATION GXL LINER +5 LAT 40MM ID GROUP 5 CUPS, REF 136-40-55 n. NOVATION GXL LINER 10 DEG FACE 40MM ID, GRP 3 CUP, REF 138-40-53 o. NOVATION GXL LINER 10 DEG FACE, 40MM ID, GRP 4 CUP, REF 138-40-54 p. NOVATION GXL LINER 10 DEG FACE, 40MM ID, GRP 5 CUP, REF 138-40-55
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022