16 results · 21ms · Sources: EU EUDAMED, US FDA

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ALERE CHOLESTECH LDX ANALYZER, ALERE CHOLESTECH LDX LIPID PROFILE - GLU CASSETTE

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

GUTTA PERCHA POINTS

FDA UDI
DiaDent Group International·08806383555623·Gutta Percha Points is used to root canal filin...

6 x 15mm CitreLock Xpress Implant Kit

FDA UDI
Acuitive Technologies, Inc.·00810027270320·

AED

FDA UDI
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.·00848657018166·Wide Jaw Punch medium 15 degree up milled 3.5mm...

K2M General Instruments

FDA UDI
VB Spine LLC·10888857551343·Offset Blade Left Size 90 mm

SUPER SECUR-FIT HA HIP STEMS AND SUPER SECUR-FIT PLUS HA HIP STEMS

FDA 510(k)
FDA Class 2 ·Orthopedic

ARSTASIS ACCESS SYSTEM

FDA 510(k)
FDA Class 2 ·Cardiovascular

NEEDLE SPINAL S/SU 27GA 3-1/2IN WHITACRE

FDA Adverse Event
Malfunction ·BECTON DICKINSON·Product code BSP·January 13, 2025

BD VACUTAINER® URINE COLLECTION, BULK TUBE

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO.·Product code KDT·December 14, 2017

PERMACOL 10X15 1.5MM

FDA Adverse Event
Death ·COVIDIEN, FORMERLY TISSUE SCIENCE LABORATORIES, PLC·Product code FTL·September 3, 2013

SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE·Product code FKX·May 20, 2013

ADVIA 2120I WITH DUAL ASPIRATE AUTOSAMPLER

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code GKZ·September 26, 2014

ACCESS

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE·Product code FPA·June 10, 2011

KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Size 4 / Adult Silicone King LAD¿ Patient Size: 50-70kg

FDA Enforcement
Class II ·Terminated·King Systems Corp.·November 28, 2012

KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Size 3 / Child Silicone King LAD¿ Patient Size: 30-50kg Product Usage: Laryngeal airway

FDA Enforcement
Class II ·Terminated·King Systems Corp.·November 28, 2012

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