14 results
·
23ms
·
Sources: EU EUDAMED, US FDA
ANALYZER, IMPACT 100
FDA 510(k)
FDA Class 1
·Clinical Chemistry
NA
FDA UDI
IMPACT PRODUCTS, LLC·B340790073M1·Medium Synthetic Vinyl Powder Free Exam Glove
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690196426·AK3 CR Femoral Trials Size 1 - 5 Left Pan
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690195139·AK3 CR Femoral Trials Size 1 - 5 Left Pan Insert
Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case without Homehub
FDA 510(k)
FDA Class 2
·Cardiovascular
D3 DFA METAPNEUMOVIRUS IDENTIFICATION KIT
FDA 510(k)
FDA Class 2
·Microbiology
HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.35 WIRE, 12, STERILE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code GCP·August 11, 2021
PFC SIGMARP STB TB IN 2.5 10.0
FDA Adverse Event
Injury
·DEPUY IRELAND·Product code NJL·May 5, 2014
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 15, 2012
1-DAY ACUVUE TRUEYE
FDA Adverse Event
Injury
·VISTAKON·Product code LPL·August 6, 2010
HF-RESECTION ELECTRODE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code GCP·March 8, 2023
TELESCOPE, 3 MM, 30°, WIDEANGLE, AUTOCLAVABLE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code GCP·April 25, 2023
HF-RESECTION ELECTRODE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code GCP·March 8, 2023
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-35; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024