13 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
BACTIDROP(TM) SPOT INDOLE
FDA 510(k)
FDA Class 1
·Microbiology
Novo Surgical
FDA UDI
NOVO SURGICAL, INC.·G5869130040·osteotome caps, gas or steam permeable, latex-f...
TRULOAD (TM) SCREW DELIVERY SYSTEM
FDA UDI
BIOMET MICROFIXATION, INC·00841036164119·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450384794·
PDS(TM) BARBED SUTURES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
COCAINE
FDA 510(k)
FDA Class 2
·Clinical Toxicology
S8 COMPACT - AMERICAS
FDA Adverse Event
Malfunction
·RESMED LTD·Product code BZD·June 26, 2014
0.8% SURGISCREEN FOR GEL
FDA Adverse Event
Malfunction
·ORTHO CLINICAL DIAGNOSTICS·Product code KSZ·January 14, 2013
MODULAR TAPERLOC FEMORAL REDUCED DISTAL 20 X 160MM TYPE I TAPER
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code LPH·December 2, 2010
Ethicon Stratafix Symmetric PDS Plus Knotless Tissue Control Device Ethicon LLC Guaynabo, Puerto Rico 00969. Intended for general soft tissue approximation where use of an absorbable suture is appropriate.
FDA Enforcement
Class II
·Terminated·Ethicon, Inc.·December 18, 2013
GALAXY G3 XSFT 4MM X 8CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·July 7, 2020
GALAXY G3 5MM X 10CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·July 7, 2020
Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024