20 results · 36ms · Sources: EU EUDAMED, US FDA

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FILMARRAY RESPIRATORY PANEL (RP)

FDA 510(k)
FDA Class 2 ·Microbiology

General Instruments

FDA UDI
ALPHATEC SPINE, INC.·00840180515440·LIF Disc Prep Slap Hammer Adapter

Lotus Plus®

FDA UDI
Ortho Organizers, Inc.·00190707191276·Lotus Plus DS SL Buccal Tubes A R 022 LR -25°To...

Lotus Plus DS

FDA UDI
ORTHO TECHNOLOGY, INC.·00190730025289·Lotus Plus DS SL Buccal Tubes A R 022 LR -25°T ...

Votion™

FDA UDI
Ortho Organizers, Inc.·00190707109967·Votion™ Mini .022 LR7 NC SBT -25T 0A 0DO DB (10PK)

Votion

FDA UDI
ORTHO TECHNOLOGY, INC.·00190730009463·Votion™ .022 LR6 NC SBT -25T 0A 4DDO DB (10PK)

Lotus Plus®

FDA UDI
Ortho Organizers, Inc.·00190707191191·Lotus Plus DS SL Buccal Tubes P R 022 LR -25°To...

Lotus Plus DS

FDA UDI
ORTHO TECHNOLOGY, INC.·00190730025203·Lotus Plus DS SL Buccal Tubes P R 022 LR -25°T ...

Votion™

FDA UDI
Ortho Organizers, Inc.·00190707109806·Votion™ .022 LR6 NC SBT -25T 0A 4DDO DB (10PK)

Votion

FDA UDI
ORTHO TECHNOLOGY, INC.·00190730009623·Votion™ Mini .022 LR7 NC SBT -25T 0A 0DO DB (10PK)

OPTICROSS

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·August 22, 2025

OPTICROSS

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·September 23, 2025

MYRIAN 1.11

FDA 510(k)
FDA Class 2 ·Radiology

CLEAN AND BOOST

FDA 510(k)
FDA Class 2 ·Dental

U-BLADE SET, TI GAMMA3 10.5X100MM

FDA Adverse Event
Injury ·STRYKER OSETOSYNTHESIS KIEL·Product code HSB·December 18, 2012

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·May 20, 2025

DCS 95° 14HO L242 SST

FDA Adverse Event
Injury ·SYNTHES ELMIRA·Product code KTT·May 22, 2013

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 26, 2014

36CM PERM CATH KIT X5

FDA Adverse Event
Malfunction ·COVIDIEN·Product code LFJ·June 10, 2011

KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Size 5 / Adult Silicone King LAD¿ Patient Size: >70kg Product Usage: Laryngeal airway

FDA Enforcement
Class II ·Terminated·King Systems Corp.·November 28, 2012