11 results
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25ms
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Sources: EU EUDAMED, US FDA
ONE TIME COMPOUND BENZOIN TINCTURE-
FDA 510(k)
FDA Class 1
·General Hospital
Stern Root Anchor® Mini FG Diamond Bur
FDA UDI
STERNGOLD DENTAL LLC·00841549106798·The Stern Root AnchorSystem includes the Stern ...
COMPUTED RADIOGRAPHY SCANNER
FDA 510(k)
FDA Class 2
·Radiology
SCALETRON PIEZO ULTRASOUND SCALER
FDA 510(k)
FDA Class 2
·Dental
TELEFLEX ISIS SUCTION ACCESSORY PACK
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code BTR·March 24, 2014
GORE EXCLUDER AAA ENDOPROSTHESIS
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code MIH·November 6, 2012
TRIATHLON CR X3 TIBIAL INSERT
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS MAHWAH·Product code JWH·September 9, 2010
LUMBAR PUNCTURE TRAY ADULT 20G X 3.5 DP- 4301C
FDA Adverse Event
Injury
·CAREFUSION, INC·Product code PWY·November 3, 2021
Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 314-01-02; b) Medium, Item number 314-01-03; c) Large, Item Number 314-01-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Pipeline Flex Embolization Device
FDA Enforcement
Class I
·Ongoing·Micro Therapeutics Inc,·September 15, 2021
OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021