10 results · 19ms · Sources: EU EUDAMED, US FDA

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KARL STORZ 10.5 FR. FLEXIBLE HYSTEROSCOPE

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

CD 3700 SL

FDA Adverse Event
Malfunction ·ABBOTT DIAGNOSTICS DIVISION/CELLDYN·Product code GKZ·May 23, 2007

Smart External Drain (SED) System

FDA 510(k)
FDA Class 2 ·Neurology

NEMIO XG, SAA-580A

FDA 510(k)
FDA Class 2 ·Radiology

CELL-DYN 3700 SL ANALYZER

FDA Adverse Event
Malfunction ·ABBOTT DIAGNOSTICS DIVISION·Product code GKZ·February 22, 2019

VIBRANT SURROUNDINGS

FDA Adverse Event
Injury ·VIBRANT MED-EL HEARING TECHNOLOGY GMBH·Product code MPV·June 16, 2014

9900

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 11, 2013

RETAINER BRITE CLEANING TABLETS

FDA Adverse Event
Other ·TOWER LABORATORIES LTD.·Product code JER·January 10, 2011

SINGLE FUNCTION ABC PENCIL, HAND CONTROL HANDPIECE

FDA Adverse Event
Malfunction ·CONMED ELECTROSURGERY·Product code HAM·September 11, 2015

GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. 0 DEG ACUMATCH CONSTRAINED LINER SZ E 28MM ID, REF 144-28-05; b. 0 DEG ACUMATCH CONSTRAINED LINER SZ F 28MM ID, REF 144-28-06; c. 0 DEG ACUMATCH CONSTRAINED LINER SZ G 28MM ID, REF 144-28-07; d. 0 DEG ACUMATCH CONSTRAINED LINER SZ H 28MM ID, REF 144-28-08; e. 0 DEG ACUMATCH CONSTRAINED LINER SZ J 28MM ID, REF 144-28-09; f. 0 DEG ACUMATCH CONSTRAINED LINER SZ K 28MM ID, REF 144-28-10; g. 0 DEG MCS CONSTRAINED LINER 50-52 MM, 28 MM ID, REF 146-28-04; h. 0 DEG MCS CONSTRAINED LINER 54-58 MM, 28 MM ID, REF 146-28-05; i. 0 DEG MCS CONSTRAINED LINER 60-64 MM, 32MM ID, REF 146-32-06; j. O DEG ACUMATCH CONSTRAINED LINER SZ E 32MM ID, REF 144-32-05; k. O DEG ACUMATCH CONSTRAINED LINER SZ F 32MM ID, REF 144-32-06; l. O DEG ACUMATCH CONSTRAINED LINER SZ G 32MM ID, REF 144-32-07; m. O DEG ACUMATCH CONSTRAINED LINER SZ H 32MM ID, REF 144-32-08; n. O DEG ACUMATCH CONSTRAINED LINER SZ J 32MM ID, REF 144-32-09; o. O DEG ACUMATCH CONSTRAINED LINER SZ K 32MM ID, REF 144-32-10;

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