19 results
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34ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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NIRVANA A PERSONAL LUBRICANT
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Humelock II Cemented Reversible Shoulder
FDA UDI
FX SOLUTIONS·03701037308554·TRIAL HUMERAL CUP 135/145° STANDARD Ø32 +6
RHEAD
FDA UDI
Stryker GmbH·00886385023090·Lateral Stem Trial; Size 4
NA
FDA UDI
Stryker Leibinger GmbH & Co. KG·07613154274468·BONE SCREW,CROSS-PIN,MP,SELF-TAPPING
32mm Glenosphere and Humeral Cup
FDA UDI
FX SOLUTIONS·03701037313886·STANDARD TRIAL HUMERAL CUP CUSTOM MADE 135/145°...
HEMOCUE GLUCOSE 201 SYSTEM, ARTICLE NUMBER 120706
FDA 510(k)
FDA Class 2
·Clinical Chemistry
VENUS BASIC SPINAL FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
EBV-VCA IGG ELISA TEST, MODEL EBG-100
FDA 510(k)
FDA Class 1
·Microbiology
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·March 18, 2020
BD VACUTAINER® SST¿ TUBE 13X75MM, 3.5 ML
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code JKA·November 27, 2017
BD VACUTAINER® PLUS PLASTIC SST TUBE, GOLD BD HEMOGARD¿ CLOSURE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code JKA·November 30, 2017
FLOGARD
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 10, 2011
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 20, 2013
STRETCH LATEX FREE TOURNIQUET
FDA Adverse Event
Other
·HYGENIC CORP.·Product code GAX·August 14, 2008
BD NEXIVA
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·December 10, 2024
KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Size 5 / Adult Silicone King LAD¿ Patient Size: >70kg Product Usage: Laryngeal airway
FDA Enforcement
Class II
·Terminated·King Systems Corp.·November 28, 2012
ValueLine Mat Platform Model C2230A,B,C; C922-30A, B,and C; C6904, C6903, C6902, C6901. All tables have the standard platform and the model numbers represent the additional shelves or drawers and the arrangement.
FDA Recall
Terminated
·SAMMONS PRESTON ROLYAN·Product code INT·January 25, 2006
Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic assessment of inter-proximal caries (Presently limited to RVG 6100 & 6500 bitewing radiographs in horizontal format) Identify and direct attention to potential interproximal caries sites for possible restoration or other treatment (Focus for further investigation. PRESCAN NOT INTENDED TO BE FINAL ASSESSMENT.) Track interproximal decay progression over time Patient education tool
FDA Enforcement
Class II
·Terminated·GA Industries·May 6, 2015
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022