13 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PRO-TOE X-FLEX HAMMERTOE FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
BIOMET KNEE SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304232655·
3M™ Unitek™
FDA UDI
3M UNITEK CORPORATION·00652221037954·Unitek(TM) Bicuspid Band General Purpose Wide U...
K2M General Instruments
FDA UDI
VB Spine LLC·10888857583207·Modular Trial 22x8x19mm, 7°
E-PAIN CARE
FDA 510(k)
FDA Class 2
·General Hospital
NOBELPROCERA TI ABUTMENT THOMMEN PLATFORMS
FDA 510(k)
FDA Class 2
·Dental
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 5, 2025
BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM
FDA Adverse Event
Malfunction
·BD (SUZHOU)·Product code FOZ·March 3, 2020
POWERHEART G5 AUTOMATIC AED
FDA Adverse Event
Malfunction
·CARDIAC SCIENCE CORPORATION·Product code MKJ·October 18, 2018
PARADIGM INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code LZG·October 4, 2014
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·June 27, 2011
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 3, 2013
Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024