18 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ANS1 SOFTWARE
FDA 510(k)
FDA Class 2
·Cardiovascular
XLIF Decade Plate
FDA UDI
Nuvasive, Inc.·00887517317063·XLIF Decade Plate, 4-Hole Size 12
N/A
FDA UDI
TETRA MEDICAL SUPPLY CORP.·00614138109926·DELUXE POST-OP SHOE FEMALE MEDIUM
Gyrus ACMI
FDA UDI
Gyrus ACMI, LLC·00821925014596·SHEA CUP PISTON SMALL, LEFT 5.0 MM LENGTH FLUOR...
AGXO
FDA UDI
Oticon A/S·05707131269850·H330, DESIGNRITE 10 WL STG AGXO
General Instruments
FDA UDI
ALPHATEC SPINE, INC.·00840180521229·Low Profile Trial Drill Guide Drill -12mm
TRIDENT T ACETABULAR SHELLS
FDA 510(k)
FDA Class 2
·Orthopedic
BIOLOX DELTA CERAMIC FEMORAL HEADS
FDA 510(k)
FDA Class 2
·Orthopedic
Specials
FDA UDI
Seaspine Orthopedics Corporation·10889981441425·ALIF Paddle Distractor 12mm, 10°
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 28, 2026
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 4, 2025
MEDTRONIC MINIMED 670G
FDA Adverse Event
Injury
·MEDTRONIC·Product code CGA·December 6, 2016
IDENTITY XL DR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC, CRMD·Product code DXY·January 13, 2014
3.5MM 90-S SERFAS ENERGY SUCTION PROBE
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY-SAN JOSE·Product code GEI·May 31, 2013
GEM PREMIER 4000
FDA Adverse Event
Malfunction
·INSTRUMENTATION LABORATORY CO.·Product code MZV·June 17, 2011
BD NEOFLON¿ IV CANNULA
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FOZ·March 14, 2022
KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case Size 4 / Adult ClearSeal King LAD¿ Patient Size: 50-70kg Product Usage: Laryngeal airway
FDA Enforcement
Class II
·Terminated·King Systems Corp.·November 28, 2012
Breast Pack, Kit part number AMS3238, AMS3238(A, AMS3691, AMS4419, PSS1541, PSS1784, PSS1784(A, PSS1784(B, PSS2272, and PSS2272(A. convenience custom kits used for general surgery in hospital operating room
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016