13 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CANNULATED SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Alpha-Tec Systems
FDA UDI
Alpha-TEC Systems, Inc.·00816085023342·M/15 Phosphate Buffer 50x40ml
LIFEPAK® 12 defibrillator/monitor
FDA UDI
PHYSIO-CONTROL, INC.·00885074855752·LP12AABCBBBACBBBBABAAAAALP12 MONITOR-DEFIB
EVERSHEARS BIPOLAR SCISSORS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
A.V. FISTULA NEEDLE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
0001222315-2024-003496
FDA Adverse Event
Injury
·STRAUMANN MANUFACTURING, INC.·Product code DZE·December 30, 2024
ALVEOLAR DISTRACTOR DISTRACTION-L 8 TI
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code MQN·January 2, 2014
TI VECTRA-T PLATE
FDA Adverse Event
Malfunction
·SYNTHES (USA)·Product code KWQ·February 28, 2013
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·March 1, 2011
EXTRACTION SCREWDRIVER
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code HXX·August 12, 2014
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