9 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NIPRO BLOOD COLLECTION NEEDLE
FDA 510(k)
FDA Class 2
·General Hospital
NOMAD SLEEP SYSTEM RECORDER, MODEL PMU800
FDA 510(k)
FDA Class 2
·Neurology
OUCHTERLONY AGAR PLATES
FDA 510(k)
FDA Class 1
·Immunology
NOTINGHM SHLDR HUM HEAD 48X17 OFFSET
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code KWS·January 19, 2016
COD.712 TOP CIRC.RACC.CARDIO
FDA Adverse Event
Other
·SORIN GROUP ITALIA·Product code DTN·December 15, 2011
AIRVANCE BONE SCREW (REPOSE)
FDA Adverse Event
Injury
·MEDTRONIC XOMED, INC.·Product code LRK·March 7, 2013
SPRINT
FDA Adverse Event
Injury
·MPRI·Product code LWS·August 8, 2014
2649622-2010-05521
FDA Adverse Event
Injury
·MPRI·February 15, 2011
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