16 results · 24ms · Sources: EU EUDAMED, US FDA

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PLASTIC NEEDLE WITH MANDRIN 2.0 DIAMETER LENGTH 113MM

FDA 510(k)
FDA Class 2 ·Radiology

SPERMCHECK FERTILITY

FDA 510(k)
FDA Class 2 ·Hematology

GIVEN DIAGNOSTIC SYSTEM

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM

FDA Adverse Event
Injury ·AV-TEMECULA-CT·Product code NIQ·April 29, 2019

XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM

FDA Adverse Event
Injury ·AV-TEMECULA-CT·Product code NIQ·April 29, 2019

PERCLOSE PROGLIDE 6F (2.0MM)

FDA Adverse Event
Injury ·ABBOTT VASCULAR·Product code MGB·October 13, 2023

PERCLOSE PROGLIDE 6F (2.0MM)

FDA Adverse Event
Injury ·ABBOTT VASCULAR·Product code MGB·October 13, 2023

LIGAMAX-5MM ENDO CLIP APPLIER

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·May 20, 2013

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 26, 2014

ALUMINA V40-FEMORAL HEAD 32MM, +4MM NK

FDA Adverse Event
Injury ·STRYKER ORTHOPAEDICS CORK·Product code LZO·June 2, 2011

VERCISE? CARTESIA?

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code NHL·July 7, 2025

XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM

FDA Adverse Event
Injury ·AV-TEMECULA-CT·Product code NIQ·April 29, 2019

PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

FDA Adverse Event
Injury ·ABBOTT VASCULAR·Product code MGB·October 23, 2023

MEDRAD Hand Controller Sheath, Catalog number AVA 500 HCS/3010903, for cardiac catheterization procedures. The Sterile Sheath is specifically intended for use in the x-ray angiography environment to cover the Medrad Avanta Sterile Hand Controller to prevent cross contamination between patients.

FDA Enforcement
Class II ·Terminated·Medrad Inc·February 27, 2013

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

Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024