13 results
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23ms
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Sources: EU EUDAMED, US FDA
SENSEI X ROBOTIC CATHETER SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
REPICCI II RESURFACING KNEE SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304449893·
GUS
FDA UDI
CIVCO MEDICAL INSTRUMENTS CO., INC.·00841436112345·G18-E Gus countertop station
GEN4 Direct Access
FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828101585·GEN4 Direct Access
ADVANCE MEDICAL DESIGNS FLUID POUCH
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ASPIJECT SELF-ASPIRATING DENTAL INJECTION SYRINGE
FDA 510(k)
FDA Class 2
·Dental
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·May 9, 2013
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 19, 2011
OPES ASPIRATING ABLATOR, 3MM, 90 DEGREE, LOW PROFILE
FDA Adverse Event
Other
·ARTHREX, INC.·Product code GEI·August 7, 2008
CLEARCANNULA-THREADED 5.5MMX75MM 5PK -ST
FDA Adverse Event
Malfunction
·DEPUY MITEK LLC US·Product code GEA·September 10, 2024
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025
CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 ( 21-2120 , 21-2125 , and 21-2127 ) 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