16 results
·
23ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
ALN OPTIONAL VANA CAVA FILTER
FDA 510(k)
FDA Class 2
·Cardiovascular
JOBST forMen Casual
FDA UDI
BSN MEDICAL, INC.·00035664131241·FOR MEN CASUAL 20-30 MM HG KNEE HIGH CLOSED TOE...
n/a
FDA UDI
Ortho Development Corporation·00822409076543·Trial Head 28mm + 15
NEO / Kinetic Anterior Cervical Plate System
FDA UDI
Life Spine, Inc.·00190837036416·Fixed Angle Awl
MODIFICATION TO SCOOPER DRUG/ADULTERATION TEST CUP
FDA 510(k)
FDA Class 2
·Clinical Toxicology
SERIES II X3 LARGE DIAMETER ACCETABULAR INSERTS
FDA 510(k)
FDA Class 2
·Orthopedic
PAGEWRITER TC 20 CARDIOGRAPH
FDA Adverse Event
Malfunction
·PHILIPS GOLDWAY (SHENZHEN) INDUSTRIAL INC·Product code DPS·May 17, 2021
LINER: MPACT FLAT PE HC LINER Ø36/E
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·June 13, 2022
UNKNOWN SCREW
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code PAO·February 4, 2015
IMPAX CV OUTBOUND (RESULTS MANAGEMENT 2.08)
FDA Adverse Event
Malfunction
·AGFA HEALTHCARE CORP·Product code LLZ·February 28, 2014
PLMA DVC V11.51 1 N
FDA Adverse Event
Malfunction
·HOSPIRA HOLDINGS DE COSTA RICA LTD.·Product code FRN·May 9, 2013
PRECISION®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 3, 2011
4.5 BROAD SCP PLT 26-H STER
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·June 21, 2017
Azurion 7 B20; System Code: (1)722068, (2)722226, (3)722236;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
Model Number L231, PROPONENT DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025