17 results
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26ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PARSFIX CABLE-SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
TruForm
FDA UDI
Rmo, Inc.·00885797099839·MD 1ST BI BD KT N/L UNIV 97
Alpha-Tec Systems
FDA UDI
Alpha-TEC Systems, Inc.·00816085022765·Wheatley's Trichrome Stain 500ml
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011003351000·Hollow chop pliers Mini, Premium Line
FLUOROTEX II SURGICAL MESH
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
HANWELLA LATEX PATIENT EXAM. GLOVES POWDER-FREE
FDA 510(k)
FDA Class 1
·General Hospital
ENDEAVOR SPRINT RX
FDA Adverse Event
Death
·MEDTRONIC IRELAND·Product code NIQ·March 14, 2013
ARCHITECT I2000SR ANALYZER
FDA Adverse Event
Malfunction
·ABBOTT MANUFACTURING, INC.·Product code JJE·March 1, 2011
BD PARADIGAM LINK GLUCOSE MONITOR
FDA Adverse Event
Other
·NOVA BIOMEDICAL CORP.·Product code NBW·February 27, 2008
VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAM·October 12, 2021
BD 20 ML SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·December 7, 2021
BIOLOX DELTA, CERAMIC FEMORAL HEAD, M, 32/0, TAPER 12/14
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code LZO·May 28, 2019
"2.4MM" SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code HWC·June 1, 2018
"2.4MM" SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code HWC·June 1, 2018
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
Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; 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