15 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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