26 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MR
FDA 510(k)
FDA Class 2
·Radiology
CoRoent
FDA UDI
Nuvasive, Inc.·00887517569127·CoRoent Ant TLIF Ti, 11x10x34mm 0°
Trinity Acetabular Hip System
FDA UDI
CORIN LTD·05055343897478·Insert Trial (Size 3)
Accufit
FDA UDI
Ortho Organizers, Inc.·00190707185190·AccuFit™ Molar Band UL7 - 34
PMT CORPORATION - STEREOTACTIC
FDA UDI
PMT CORPORATION·00650551039396·BRW/CRW-SPLIT CANNULA, FOR 2.7MM AND 3.2MM DRILL
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319722053·Maltz (Cottle) Nasal Rasp 8-1/2" (21cm), backwa...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197125413·Sayre Periosteal Elevator
17cm (...
MODULITH LITHOTRIPSY, MODEL SLK FOR THE FRAGMENTATION OF URINARY AND UPPER URETERAL CALCULI
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
VENUS FACET SCREW SYSTEM
FDA 510(k)
FDA Unclassified
·Unknown
FREEDOM CYCLER
FDA Adverse Event
Malfunction
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code FKX·September 16, 1998
T:FLEX INSULIN DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code LZG·December 13, 2017
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 5, 2025
LINEAR ST
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·September 19, 2023
SHILEY DISPOSABLE CANNULA LOW PRESSURE
FDA Adverse Event
Injury
·COVIDIEN/FORMERLY TYCO HEALTHCARE·Product code JOH·August 8, 2011
MAXZERO NEEDLELESS CONNECTOR
FDA Adverse Event
Malfunction
·CAREFUSION CORPORATION·Product code FPA·August 8, 2014
FINELINE II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·July 8, 2013
ELECSYS HBSAG II
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LOM·September 19, 2025
PRYTIME MEDICAL REBOA Catheter Introducer Kit, REF: KT1835C, Contents: Needle, 18 GA x 7 CM ECHOGENIC, STERILE, 1 EA, SYRINGE, 30CC, STERILE 1 EA, INTRODUCER SHEATH KIT, 7 FR W/.035 SHORT GUIDEWIRE, STERILE 1 EA., PREFILLED, STERILE FIELD SALINE SYRINGE, 10 ML, 4 EA, CLAMP, 5 FR, STERILE, 1 EA, SCALPEL, #11SS, STERILE, 1 EA, SUTURE, NYLON, 18", 2-0, REVERSE CUTTING, STERILE 1 EA, THREE QUARTER DRAPE, STERILE 1 EA, INSERT, SALINE 1 EA, INSERT, CLAMP 1 EA UDI: (01) 0 0863092 00010 1
FDA Recall
Terminated
·Prytime Medical Devices, Inc.·Product code OFC·December 14, 2020
Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. Model Number CF4203 (Reorder No. 21-0340-01) 105 inch length/267 cm, 25ml priming volume, 60 drops/ml, 2 SureSite Prepierced Injection Sites.
FDA Recall
Terminated
·Smiths Medical MD, Inc.·Product code FPA·December 3, 2004
PryTime Medical - ER-Reboa Plus Catheter, Ref: ER7232PLUS, Guidewire Free, Compatabel with 7Fr introducer Sheaths, Arterial Line, Rx Only, UDI: (01) 0 0850001 10505 7 - Product Usage: intended for temporary occlusion of large vessels and blood pressure monitoring including patients requiring emergency control of hemorrhage.
FDA Recall
Terminated
·Prytime Medical Devices, Inc.·Product code MJN·October 29, 2020