11 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CORDIS POLYPROPYLENE STRAIGHT, T & Y CONNECTOR
FDA 510(k)
FDA Class 2
·Neurology
Bosworth Trim Plus
FDA UDI
Harry J Bosworth Company·H66809219361·4 oz PMMA Temp Resin Liquid
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471122932·K-WIRE - DOUBLE TROCAR 1.25mm DIA x 150mm
MOIST PUNCTAL PLUG SYSTEM
FDA 510(k)
FDA Unclassified
·Unknown
NAVIOPFS
FDA 510(k)
FDA Class 2
·Neurology
IMPELLA CP
FDA Adverse Event
Injury
·ABIOMED, INC.·Product code OZD·November 24, 2025
POWER PRO AMBULANCE COT
FDA Adverse Event
Malfunction
·STRYKER CORP., MEDICAL DIV.·Product code INK·December 7, 2010
ACIST
FDA Adverse Event
Injury
·ACIST MEDICAL SYSTEMS, INC.·Product code DXT·January 11, 2013
FINELINE II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code DTB·July 9, 2014
LIGACLIP
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·September 26, 2017
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