18 results · 23ms · Sources: EU EUDAMED, US FDA

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BIODYNAMICS SMALL JOINT BRUSH #1203

FDA 510(k)
FDA Class 1 ·General, Plastic Surgery

ACRYDERM SILVER ANTIMICROBIAL OTC WOUND GEL

FDA 510(k)
FDA Unclassified ·Unknown

FLUOROSCOPE, C-ARM

FDA 510(k)
FDA Class 2 ·Radiology

G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code MDS·June 12, 2014

PROMUS ELEMENT¿ PLUS

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·December 12, 2012

OT PING METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 26, 2015

BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS

FDA Adverse Event
Injury ·BECTON DICKINSON CARIBE LTD.·Product code MDB·August 16, 2023

BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS

FDA Adverse Event
Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code MDB·August 16, 2023

BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS

FDA Adverse Event
Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code MDB·March 20, 2023

BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS

FDA Adverse Event
Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code MDB·December 1, 2021

BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS

FDA Adverse Event
Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code MDB·January 11, 2023

BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS

FDA Adverse Event
Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code MDB·April 4, 2023

BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS

FDA Adverse Event
Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code MDB·March 20, 2024

BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS

FDA Adverse Event
Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code MDB·September 9, 2022

SILK SUTURE 30"(75CM) 5-0 BLK

FDA Adverse Event
Malfunction ·ETHICON INC.·Product code GAP·December 22, 2020

BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS

FDA Adverse Event
Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code MDB·July 8, 2022

BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS

FDA Adverse Event
Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code MDB·February 1, 2022

GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS, REF 130-32-51 b. NOVATION GXL LINER NEUTRAL, 36MM ID, GROUP 2 CUPS, REF 130-36-52 c. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 3 CUPS, REF 130-40-53 d. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 4 CUPS, REF 130-40-54 e. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 5 CUPS, REF 130-40-55 f. NOVATION GXL LINER LIPPED 32MM ID, GROUP 1 CUPS, REF 132-32-51 g. NOVATION GXL LINER LIPPED 36MM ID GROUP 2, REF 132-36-52 h. NOVATION GXL LINER LIPPED 40MM ID, GROUP 3 CUPS, REF 132-40-53 i. NOVATION GXL LINER LIPPED 40MM ID, GROUP 4 CUPS, REF 132-40-54 j. NOVATION GXL LINER LIPPED 40MM ID, GROUP 5 CUPS, REF 132-40-55 k. NOVATION GXL LINER +5 LAT 40MM GROUP 3 CUPS, REF 136-40-53 l. NOVATION GXL LINER +5 LAT 40MM ID GROUP 4 CUPS, REF 136-40-54 m. NOVATION GXL LINER +5 LAT 40MM ID GROUP 5 CUPS, REF 136-40-55 n. NOVATION GXL LINER 10 DEG FACE 40MM ID, GRP 3 CUP, REF 138-40-53 o. NOVATION GXL LINER 10 DEG FACE, 40MM ID, GRP 4 CUP, REF 138-40-54 p. NOVATION GXL LINER 10 DEG FACE, 40MM ID, GRP 5 CUP, REF 138-40-55

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·September 21, 2022