14 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EXATECH MCS POROUS COATED TOTAL HIP FEMORAL STEM
FDA 510(k)
FDA Class 2
·Orthopedic
RIWO-ART
FDA UDI
Richard Wolf GmbH·04055207044773·TROCAR TIP POINTED SZ 5.5MM WL 169MM distal ti...
Couture Essence
FDA UDI
Carolon Company·00078301981137·
Couture Essence
FDA UDI
Carolon Company·00078301921133·
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690129998·Retaining Bolt, PS or PS-C Insert, Revision Tib...
Mediflex Modular III Basic Laparoscopic Instruments
FDA UDI
FLEXBAR MACHINE CORPORATION·00842102103377·Modular 3 Hook Scissors, Complete Instrument, 5...
BIOPSY SCIENCES, INC. HYDROMARK BREST BIOSY SITE MARKER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MAMMOPATH
FDA 510(k)
FDA Class 2
·Radiology
BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code MDB·January 28, 2022
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Injury
·COCHLEAR LTD.·Product code MCM·January 17, 2013
SPRINT QUATTRO SECURE
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·December 13, 2010
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·July 9, 2014
PRODISC-C IMPLANT LARGE 5MM-STERILE
FDA Adverse Event
Injury
·SYNTHES BRANDYWINE·Product code MJO·September 7, 2016
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