16 results
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26ms
·
Sources: EU EUDAMED, US FDA
COMPOSIX KUGEL MESH, MODEL 0010201,0010202,0010203,0010204,0010205
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MESH - COMPOSIX KUGEL
FDA Adverse Event
Injury
·DAVOL INC.·Product code FTL·June 14, 2011
ADVANCE®
FDA UDI
Microport Orthopedics Inc.·M684K00533231·
TruForm
FDA UDI
Rmo, Inc.·00885797099853·MN 2ND BI BD KT N/L UNIV 123
TruForm
FDA UDI
Rmo, Inc.·00885797099846·MN 1ST BI BD KT N/L R/L 134
CTA HUMERAL HEAD (COCRMO) DIA.46MM
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A.·Product code HSD·August 20, 2019
NITRILE PATIENT EXAMINATION GLOVE (BLUE COLOR) POWDER FREE, NON STERILE
FDA 510(k)
FDA Class 1
·General Hospital
NUVASIVE PERCUTANEOUS TRANSFACET/INTRAPEDICULAR SCREW
FDA 510(k)
FDA Unclassified
·Unknown
PROSTHESIS, HIP
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWY·November 11, 2021
NA
FDA UDI
Zimmer, Inc.·00889024066434·
2520274-2013-10935
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code MNI·February 28, 2013
MINICAP
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·March 1, 2011
ESPIRIT VENTILATOR
FDA Adverse Event
Malfunction
·RESPIRONICS CALIFORNIA, INC.·Product code CBK·February 27, 2008
smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD, Inc.·December 4, 2024
bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025
CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024