18 results
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18ms
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Sources: EU EUDAMED, US FDA
MIRCAS DENTAL CARTRIDGE SYRINGE AND MIRCAS COVER
FDA 510(k)
FDA Class 2
·Dental
Stern AC Implant 5.0 x 10mm, Ti
FDA UDI
STERNGOLD DENTAL LLC·00841549110085·The Stern AC Implant is a self-tapping, double ...
Mariner
FDA UDI
Seaspine Orthopedics Corporation·10889981206178·Sagittal Bender (R) 6.0
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515228115·Pick, slightly cvd tip, 6 1/4"
Curette Double Ended 2mm&3mm Cup
FDA UDI
BLINK MEDICAL LIMITED·05060480408050·
Mariner
FDA UDI
Seaspine Orthopedics Corporation·10889991163409·Sagittal Bender (R) 6.0
ADMINISTRATION SET FOR HALO II AMBULATORY INFUSION PUMP
FDA Adverse Event
Malfunction
·INFUTRONIX, LLC·Product code FPA·December 9, 2019
Standard Reusable Awl
FDA UDI
RESPONSIVE ORTHOPEDICS LLC·00811714035536·3.8 mm Reusable Awl
ACE ™NAIL EXTRACTION ADAPTOR
FDA UDI
Biomet Orthopedics, LLC·00887868064159·
ACE ™T-HANDLE QUICK COUPLE
FDA UDI
Biomet Orthopedics, LLC·00887868064166·
ACE ™QUICK COUPLE POWER ADAPTOR
FDA UDI
Biomet Orthopedics, LLC·00887868064173·
ENTELLUS MEDICAL BALLOON DEVICE
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
GALAXY
FDA 510(k)
FDA Class 2
·Dental
FLOGARD
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 30, 2014
BRAVO
FDA Adverse Event
Malfunction
·GIVEN IMAGING LTD.·Product code FFT·November 7, 2010
EON
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·December 26, 2012
OsteoMed OsteoPower Power Console: -OsteoMed OsteoPower Power Console 2 REF 450-0021-00 -OsteoMed D-Power Control Console 2 REF 450-0021-01 -Power Control Console 2 REF ECOS-450-0021-00 -OsteoMed OsteoPower Power Console 2i REF 450-0005-00 -OsteoMed D-Power Control Console 2i REF 450-0005-01 -Power Control Console 2i REF ECOS-450-0005-00 OsteoMed Footswitches: -OsteoMed BMF Footswitch REF 450-0390 -D-Bi-Directional Master Footswitch REF 450-0380 -D-Uni-Directional Footswitch II REF 450-0350 -D-Bi-Directional Footswitch II REF 450-0360 -D-Uni-Directional Master Footswitch REF 450-0370
FDA Enforcement
Class II
·Ongoing·Osteomed, LLC·December 15, 2021
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012