19 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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TENS AND EMS (TENS and Muscle Stimulator) (JT8012, JT8012B)
FDA 510(k)
FDA Class 2
·Neurology
Soft Flex Toothbrush
FDA UDI
SAFCO DENTAL SUPPLY CO.·10810063755697·Soft Flex Toothbrush, flexible head adjusts to ...
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780455615·Integra® Jarit® Cobb Style Osteotome, Straight
Darby Dental Supply, LLC
FDA UDI
DARBY DENTAL SUPPLY, LLC·00889813010662·NITI LEGACY MT CM 31MM ASST
Stainless Steel Rectangular Wire
FDA UDI
Ortho Arch Company Inc·D90925005312·.021 X .025 STAINLESS STEEL RECTANGULAR 14' LEN...
N/A
FDA UDI
BIOMET MICROFIXATION, INC·00841036155377·
Evolve
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215002589·
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197390750·Cold Light Cable with 2 light inputs and
1 ligh...
ceraMotion®
FDA UDI
DENTAURUM GmbH & Co.KG·J011250053400·ceraMotion® Zr Dentin C4, 40 g / dental ceramic...
ceraMotion®
FDA UDI
DENTAURUM GmbH & Co.KG·J011250053200·ceraMotion® Zr Dentin C4, 20 g / dental ceramic...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197152860·Cold Light Cable with 2 light inputs and
1 ligh...
HEMORAM/AGGRAM ANALYZER
FDA 510(k)
FDA Class 2
·Hematology
STALIF C; STALIF C-Ti
FDA 510(k)
FDA Class 2
·Orthopedic
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·November 14, 2014
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code MDS·September 9, 2011
HUT EXT DR FINAL ASSY-STANDARD
FDA Adverse Event
Malfunction
·LIEBEL-FLARSHEIM CO·Product code IXR·July 23, 2013
H4051 Endo Tube Holder, Pedi 2.5mm Pediatric Endotracheal Intubation Kit
FDA Enforcement
Class I
·Terminated·Smiths Medical ASD, Inc.·September 3, 2014
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 23, 2013