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

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HILL-ROM AMBULATORY CARE PROCEDURAL STRETCHER

FDA 510(k)
FDA Class 2 ·General Hospital

SYNERAD IMPACT 60, SYNERAD IMPACT 72 AND ANALOGIC AMS1600

FDA 510(k)
FDA Class 2 ·Radiology

ASAHI Caravel

FDA 510(k)
FDA Class 2 ·Cardiovascular

SUPRACONDYLAR NAIL T2 SCN 10 X 200 MM

FDA Adverse Event
Injury ·STRYKER OSTEOSYNTHESIS ¿ KIEL·Product code HSB·July 17, 2012

ZB 12/14 COCR FRDM 32MM X +3

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code KWY·December 20, 2021

ATTAIN ABILITY

FDA Adverse Event
Injury ·MPRI·Product code OJX·February 9, 2013

LIFEVEST WCD 3100 SYSTEM

FDA Adverse Event
Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·January 4, 2011

OPTICROSS?

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - FREMONT (SUD)·Product code OBJ·July 23, 2014

G7 FREEDOM CONST E1 LNR 32MM B

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code LZO·December 20, 2021

CONSTRAINED HEAD

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code KWY·January 5, 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