21 results
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29ms
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Sources: EU EUDAMED, US FDA
NVISION VLE IMAGING SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
SimPro™ Now
FDA UDI
Wellspect AB·07333387032238·Single Use Urinary Catheter with water sachet. ...
SimPro™ Now
FDA UDI
Wellspect AB·07392532188589·Single Use Urinary Catheter with water sachet. ...
RHEAD
FDA UDI
Stryker GmbH·00886385023120·Lateral Assembly Tool
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702256000·Elvarex 2/Thigh High/Open Toe, E-Version, Knee ...
TALOS®-C HA
FDA UDI
MEDITECH SPINE, LLC·B167521208000·
PGDx elio™ server
FDA UDI
PERSONAL GENOME DIAGNOSTICS INC.·00192721001432·PGDx elio™ server (reconditioned)
Ohio
FDA UDI
OHIO MEDICAL, LLC·00628101615796·DISP COLLECTION CANISTER, 1200CC
TIDI FACEMASK
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
OPTAX SYSTEM
FDA 510(k)
FDA Unclassified
·Unknown
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 16, 2025
ALARIS PUMP MODULE
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·March 18, 2021
ARCOM 28MM RNGLOC LNR HWALL 23
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·December 20, 2018
OT VERIO METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE GMBH·Product code NBW·May 20, 2013
ACCESS® WASH BUFFER II
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code LDT·June 10, 2011
PRECISION
FDA Adverse Event
Injury
·ADVANCED BIONICS NEUROMODULATION CORPORATION·Product code LGW·August 15, 2008
BIOMET TRAUMA Drill Bit, Tap, Guide Pin: [DVR Drill Bit, Item # 212000022, DVR 2.2MM DRILL BIT], [ALPS Drill Bit, Item # 214227160, 2.7X160MM CALIBRATED DRILL], [ALPS Drill Bit, Item # 824273100, 4.5X150MM DRILL], [ALPS Drill Bit, Item # 829029170, 2.5X140MM DRILL], [ALPS Drill Bit, Item # 829032170, 3.5X140MM DRILL], [ALPS Tap, Item # 824150170, 3.5X140MM CORTICAL TAP], [ALPS Guide Pin, Item # 829516150, 1.6X150MM BAYONET TIP GUIDE PIN], [ALPS Guide Pin, Item # 829516151, 1.6X150MM THREADED TIP GUIDE PIN]. Instruments are packaged in a vacuum sealed nylon pouch, which is placed in a carton with the appropriate IFU and patient record labels. Identifying labels on the pouch and the carton.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·March 30, 2022
Arthrex IBalance TKA Tibial Tray Size 2 - Catalog # AR-503-TTTC, Size 3 - Catalog # AR-503-TTTD, Size 4 -Catalog # AR-503-TTTE, Size 5 - Catalog # AR-503-TTTF, Size 6 - Catalog # AR-503-TTTG , Size 7 -Catalog # AR-503-TTTH, and Size 8 - Catalog # AR-503-TTTJ. Intended for implantation with bone cement, with the exception of the porous coated femoral components which can be used cemented or uncemented (biological fixation).
FDA Enforcement
Class II
·Terminated·Arthrex, Inc.·March 30, 2016
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
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012