36 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TENS AND EMS (TENS and Muscle Stimulator) (JT8012C,JT8016,JT9020E,JT9026)
FDA 510(k)
FDA Class 2
·Neurology
Vivid ZirDisc Wieland System
FDA UDI
PEARSON DENTAL SUPPLIES, INC.·D724Q2503601·98mmx22mm A2 Shaded
Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012
BENCO
FDA UDI
BENCO DENTAL SUPPLY CO.·00366975003720·Medium Blue Benco Dental Absorbent Points Bulk ...
Restore
FDA UDI
KEYSTONE DENTAL, INC.·D768R25036002K0·Oring Abutment
TightRail Rotating Dilator Sheath, TightRail Mini Rotating Dilator Sheath
FDA 510(k)
FDA Class 2
·Cardiovascular
TULIP CONDOM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
T:SLIM X2 INSULIN PUMP
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OYC·August 16, 2019
T:SLIM X2 INSULIN PUMP
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OYC·August 16, 2019
T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY (WITH T:CONNECT MOBILE APP)
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·August 27, 2024
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197163170·Titanium Jacobson Micro Scissors
9mm lo...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197528047·Titanium Jacobson Micro Scissors
9mm lo...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197528078·Titanium Jacobson Micro Scissors
9mm lo...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197528061·Titanium Micro Scissors
10mm l...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197528023·Titanium Micro Scissors
10mm l...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197448291·Titanium Micro Scissors
10mm l...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197448260·Titanium Micro Scissors
10mm l...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197528009·Titanium Micro Scissors
10mm l...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197448277·Titanium Micro Scissors
10mm l...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197528030·Titanium Micro Scissors
10mm l...