14 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LEMILLS VALVULOTOME
FDA 510(k)
FDA Class 2
·Cardiovascular
NexxZr™ T / D-100-14-NT-A400-SD
FDA UDI
SAGEMAX BIOCERAMICS, INC·00842271112576·
ihcDirect® CDX2 Ab, 15mL
FDA UDI
NOVODIAX, INC.·00850000596887·Clone R1014
ihcDirect® CDX2 Ab, 5mL
FDA UDI
NOVODIAX, INC.·00850000596870·Clone R1014
ihcDirect® CDX2 Ab Conjugate 5mL
FDA UDI
NOVODIAX, INC.·00850030934857·Clone R1014
LCI OPTION FOR INNOCOR
FDA 510(k)
FDA Class 2
·Anesthesiology
TRI-LOOP MICROWAVE ABLATION PROBE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
RIVA STAR SILVER DIAMINE FLUORIDE
FDA Adverse Event
Injury
·SDI LIMITED·Product code LBH·February 13, 2019
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 29, 2013
CROSSFIRE 0 DEG INSERT
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS MAHWAH·Product code LZO·August 21, 2008
AMPLATZER® SEPTAL OCCLUDER
FDA Adverse Event
AGA MEDICAL CORPORATION·Product code MLV·June 16, 2011
MPACT ACETABULAR SHELL Ø54 TWO-HOLES
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·July 28, 2016
SKY 1 LEVEL PLTE 18MM TI
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SÃ RL CH·Product code KWQ·March 23, 2022
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024