35 results
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29ms
·
Sources: EU EUDAMED, US FDA
SAFE'N'SOUND PASSIVE DELIVERY SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
Preci-Clix
FDA UDI
Preat Corporation·00842092128039·Clix Red Females- Increased - Each
Bur PM2-70 80K diam EC Ø6.0 St
FDA UDI
Bien-Air Surgery SA·17630055516777·
Marienfeld Superior
FDA UDI
Paul Marienfeld GmbH & Co. KG·04250317300416·
Preci-Clix
FDA UDI
Preat Corporation·00842092119495·Clix Red Females - Increased (50-Pack)
Indus
FDA UDI
SPINEFRONTIER, INC.·00190361035466·Indus Invue MAX Symmetrical ACP, 1 Level, 33mm
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K0112330·Tap, 5.50mm, Fixed Sleeve
PELVICOL ACELLULAR COLLAGEN MATRIX
FDA Adverse Event
Injury
·TISSUE SCIENCE LABORATORIES·Product code FTL·May 15, 2013
MODIFICATION TO GLUCOSURE BGM SYSTEM, MODEL 221100
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ACTI-FLEX FLUID DELIVERY SYSTEM OR ACTI-FLEX F D S
FDA 510(k)
FDA Class 2
·General Hospital
AVAULTA POSTERIOR BIOSYNTHETIC SUPPORT SYSTEM
FDA Adverse Event
SOFRADIM PRODUCTION·Product code FTL·January 16, 2013
AVAULTA BIOSYNTHETIC SUPPORT SYSTEM
FDA Adverse Event
Injury
·SOFRADIM PRODUCTION·Product code FTL·January 16, 2013
UNKNOWN PELVICOL PRODUCT
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY TISSUE·Product code FTL·February 12, 2013
ALIGN TO URETHRAL SUPPORT SYSTEM - HALO
FDA Adverse Event
Injury
·C.R. BARD, INC. (COVINGTON) -1018233·Product code OTN·March 20, 2013
UNIFY QUADRA CRT-D, DF4 CONNECTOR
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·May 9, 2013
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FKX·September 19, 2014
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·May 24, 2011
EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·January 30, 2025
Part 510636 Disposable Infusion Pump, ...Elastomeric Pump 600 mL( 300 ml perside), 2 to 10 ml/hr. Delivery time 60 to 144 hours; found in the following kits: GoBlock Kit 510646, Disposable Infusion Pump for drug delivery. Symbios GOBlock System is a disposable, self contained infusion system.
FDA Enforcement
Class I
·Terminated·Symbios Medical Products, LLC·June 12, 2013
MooreMedical Supporting Health & Care...MooreBrand Blood Glucose Monitor for Self-Testing & Multi-Patient Use TRUEtrack. Manufactured by: NIPRO DIAGNOSTICS, Fort Lauderdale, FL 33309 U.S.A. Is intended for the quantitative determination of glucose in human whole blood taken from finger or forearm.
FDA Enforcement
Class II
·Terminated·Nipro Diagnostics, Inc.·February 12, 2014