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