35 results · 29ms · Sources: EU EUDAMED, US FDA

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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