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

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FOOTPRINT MEDICAL POLYURETHANE UMBILICAL CATHETER

FDA 510(k)
FDA Class 2 ·General Hospital

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04064984699564·GENUMEDI PSS BLUE, SIZE IV

CoRoent

FDA UDI
Nuvasive, Inc.·00887517564542·CoRoent Ant TLIF PEEK, 12x10x30mm 4°

LOCATOR R-Tx

FDA UDI
Zest Anchors, LLC·00840481133725·LOCATOR R-Tx Abutment, Keystone Conical, 4mm Cuff

ST AIA PACK HBA1C

FDA 510(k)
FDA Class 2 ·Hematology

DISPOSABLE LIGHT HANDLE AND ADAPTOR

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

RUSCH ULTRA TRACHEOFLEX TRACHEOSTOMY SET

FDA Adverse Event
Malfunction ·WILLY RUSCH GMBH·Product code BTO·July 16, 2007

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·March 26, 2026

OBTRYX SYSTEM

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·May 20, 2013

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·September 26, 2014

CRYSTALLINE ACTIVE FIXATION

FDA Adverse Event
Injury ·MPRI·Product code DTB·October 1, 2015

HANDLE CEV669E DIA 5MM ERG BIPOLAR

FDA Adverse Event
Malfunction ·MEDTRONIC XOMED INSTRUMENTATION S.A.S.·Product code GEI·August 29, 2013

I.V. Start Kit - Tegaderm Dressing - Catheter Securement - Prevantics Catalog Number: 822

FDA Enforcement
Class II ·Terminated·Busse Hospital Disposables, Inc.·June 8, 2022

Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded iliac leg graft - distal cuff diameter 20 mm - usable length 88mm - delivery system 16 FR; Catalog no. TFLE-20-88.

FDA Recall
Terminated ·Cook, Inc.·Product code MIH·June 10, 2004

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