85 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ELLIPSE JUVIA, MODEL 9EJU7465
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0120230·Screwdriver, Extended Tab, Fixed Tap Sleeve, As...
Australis ALIF Cage
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215128043·
Genius Total Knee System
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215023003·
Optimus Drill Q - 3.5mm 25mm
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215058265·
ANCHOR GUIDE LESION LOCALIZATION DEVICE; ANCOR GUIDE HOLDER; RF GENERATOR CABLE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MEDMIRA RAPID H. PYLORI ANTIBODY TEST, MODEL 10714
FDA 510(k)
FDA Class 1
·Microbiology
QUILL SRS
FDA Adverse Event
Malfunction
·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code NEW·September 3, 2008
QUILL SRS
FDA Adverse Event
Other
·SURGICAL SPECIALTIES CORPORATION (DBA ANGIOTECH)·Product code NEW·May 12, 2009
QUILL SRS
FDA Adverse Event
Other
·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code NEW·February 13, 2009
NEUROFORM 3- 4.0 X 20MM
FDA Adverse Event
Injury
·STRYKER NEUROVASCULAR-CALIF·Product code NJE·April 22, 2013
SENSIA SR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL, INC.·Product code DXY·July 10, 2008
LIGAMAX-5MM
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·April 28, 2011
QUILL SRS
FDA Adverse Event
Other
·SURGICAL SPECIALTIES CORP (DBA ANGIOTECH)·Product code NEW·March 15, 2010
QUILL SRS
FDA Adverse Event
Other
·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code NEW·August 24, 2009
QUILL KNOTLESS TISSUE-CLOSURE DEVICE
FDA Adverse Event
Injury
·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code NEW·May 11, 2011
QUILL SRS
FDA Adverse Event
Other
·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code NEW·July 26, 2012
PCRopsis Reagent RVD with RVD Enhancer: a) 1 mL, VALIDATION USE ONLY, REF 78336001; b) 25 mL, REF 78336025; c) 100 mL, REF 78336100; Extraction-free PCR from saliva, urine, &swab specimens in transport medium, nucleic acid extraction from a variety of biological samples
FDA Enforcement
Class II
·Ongoing·Entopsis , Inc.·April 5, 2023
QUILL SRS
FDA Adverse Event
Other
·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code NEW·April 19, 2010
QUILL SRS
FDA Adverse Event
Other
·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code NEW·January 5, 2011