11 results
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19ms
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Sources: EU EUDAMED, US FDA
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