641 results
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28ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CARE ZY5BA OXYGEN CONCENTRATOR
FDA 510(k)
FDA Class 2
·Anesthesiology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772814688·GENUMEDI SILVER SIZE V
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X1022450·10mm H x 22mm W x 45mm L x 0 degrees XLIF
JOBST Bella Strong
FDA UDI
BSN MEDICAL, INC.·00035664009205·BELLA STRONG 15-20 MM HG ARMSLEEVE KNIT WELT SI...
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776186302·Supercut Reynolds Tenotomy Scissors
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B16741022450·
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X10224580·10mm H x 22mm W x 45mm L x 8 degrees XLIF
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X102245120·10mm H x 22mm W x 45mm L x 12 degrees XLIF
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587L102245120·10mm H x 22mm W x 45mm L XLIF Trial 12 degree L...
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780375326·Integra® Jarit® Reynolds Scissors, 5-1/8", Supe...
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B1674102245060·
HS/HG PROSTHETIC SYSTEM
FDA 510(k)
FDA Class 2
·Dental
ULTRASEAL ID
FDA 510(k)
FDA Class 2
·Dental
HTR-PMI HANSEN LF FRT SP PAR T
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code GXN·May 9, 2013
UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code JJE·September 19, 2014
CAPTURA SERRATED FORCEPS WITH SPIKE
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code FCL·May 23, 2011
TRUE Dilatation Balloon Valvuloplasty Catheter, REF Numbers: 02045-11, 02245-12, 02445-12, and 02645-13; Sizes: 20mm x 4.5cm, 22mm x 4.5cm, 24mm x 4.5cm, and 26mm x 4.5cm; Intended to be used for balloon aortic valvuloplasty.
FDA Recall
Terminated
·Loma Vista Medical·Product code OZT·March 18, 2013
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDT·October 13, 2021
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDT·February 22, 2022
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDT·July 28, 2021