18 results · 23ms · Sources: EU EUDAMED, 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