21 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Proximerge 2 Dental Implant System
FDA 510(k)
FDA Class 2
·Dental
Luna
FDA UDI
ULTRADENT PRODUCTS, INC.·00883205003461·Luna Opal R Mini .018 Kit 5x5 U Hooks 3, 4, 5
Kompressor™ Compression Screw System
FDA UDI
Ascension Orthopedics, Inc.·10381780280361·MINI K-WIRE 0.9MM
Kompressor
FDA UDI
Smith & Nephew, Inc.·00885556869062·MINI K-WIRE 0.9MM
PMT® Halo Systems
FDA UDI
PMT CORPORATION·00650551113409·HALO, 1203-5 VEST XX-LARGE, LAMBSWOOL LINER, 12...
APTIMA COMBO 2 ASSAY
FDA 510(k)
FDA Class 2
·Microbiology
SLT LASERPRO CTH HOLMIUM LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BLACKHAWK Cervical Spacer System
FDA UDI
Choice Spine, LP·00840996164450·BLACKHAWK,STERILE,LORDOTIC,14X12X9
ACCU-CHEK COMFORT CURVE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS CORP.·Product code CFR·March 29, 2006
EASYPOINT NEEDLE
FDA Adverse Event
Injury
·RETRACTABLE TECHNOLOGIES, INC.·Product code FMI·February 9, 2023
EASYPOINT NEEDLE
FDA Adverse Event
Injury
·RETRACTABLE TECHNOLOGIES, INC.·Product code FMI·February 9, 2023
WATCHMAN LAA FLX CLOSURE DEVICE & DELIVERY SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code NGV·November 29, 2022
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·October 29, 2014
TAXUS (TM) LIBERTÉ (TM)
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·August 15, 2011
GYNECARE TVT OBURATOR SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·July 8, 2013
WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code NGV·November 29, 2022
OPTIPAC 80 REFOB BONE CMT R-3
FDA Adverse Event
Injury
·BIOMET FRANCE S.A.R.L.·Product code MBB·July 7, 2022
PANTHER FUSION ADV/HMPV/RV ASSAY
FDA Adverse Event
Injury
·HOLOGIC INCORPORATED·Product code OCC·October 12, 2021
PANTHER FUSION SARS-COV-2 ASSAY PPR SOLUTION
FDA Adverse Event
Malfunction
·HOLOGIC INCORPORATED·Product code QJR·October 11, 2021
AcuTwist Acutrak Compression Screws Part Number/Part Description: AI-0010-S 10mm AcuTwist¿ Acutrak Compression Screw AI-0012-S 12mm AcuTwist¿ Acutrak Compression Screw AI-0014-S 14mm AcuTwist¿ Acutrak Compression Screw AI-0016-S 16mm AcuTwist¿ Acutrak Compression Screw AI-0018-S 18mm AcuTwist¿ Acutrak Compression Screw AI-0020 20mm AcuTwist¿ Acutrak Compression Screw AI-0020-S 20mm AcuTwist¿ Acutrak Compression Screw AI-0022-S 22mm AcuTwist¿ Acutrak Compression Screw AI-0024-S 24mm AcuTwist¿ Acutrak Compression Screw AI-0026 26mm AcuTwist¿ Acutrak Compression Screw AI-0026-S 26mm AcuTwist¿ Acutrak Compression Screw AI-0028-S 28mm AcuTwist¿ Acutrak Compression Screw AI-0030 30mm AcuTwist¿ Acutrak Compression Screw AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw
FDA Enforcement
Class II
·Ongoing·Acumed LLC·January 4, 2023