13 results · 27ms · Sources: EU EUDAMED, US FDA

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WAVE GATE

FDA 510(k)
FDA Class 2 ·Neurology

Empower Bracket

FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746122002·DB BKT SL EMPOWER PASSIVE LL 1ST BIC 022 T-12 A...

Empower2

FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746013119·DB BKT SL EMPOWER PASSIVE LL 1ST BIC 022 T-12 A...

Empower2

FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746010460·DB BKT SL EMPOWER INTERACT LL 1ST BIC 022 T-12 ...

Empower Bracket

FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746072093·DB BKT SL EMPOWER INTERACT LL 1ST BIC 022 T-12 ...

Stainless Steel Wire

FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746047619·WIRE SS GOLD TONE LOWER 012 BONWILL HAWLEY 100/PK

CENTERPIECE™ Plate Fixation System

FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00721902427350·PLATE 853-412 12MM GRFT PLT

FLEXISCOPE, MODELS 50MH AND 50 MHC

FDA 510(k)
FDA Class 1 ·General, Plastic Surgery

Sleep Profiler

FDA 510(k)
FDA Class 2 ·Neurology

COMPRESSOR MINI

FDA Adverse Event
Malfunction ·MAQUET CRITICAL CARE AB·Product code BTI·April 4, 2014

DIMENSION EXL WITH LM

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC·Product code JJE·November 30, 2012

ACCU-CHEK SPIRIT CARTRIDGE

FDA Adverse Event
Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·September 27, 2010

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