16 results
·
22ms
·
Sources: EU EUDAMED, US FDA
K-ASSAY D-DIMER WITH CALIBRATOR SET AND CALIBRATOR DILUENT
FDA 510(k)
FDA Class 2
·Hematology
N/A
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169347830·TEMPLATE 3002948 ZEVO 48MM 2 LVL
OLYMPUS ENDOSCOPIC FLUSHING PUMP MODEL OFP-1
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CVPROFILOR D0-2020 CARDIOVASCULAR PROFILING SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
ACCU-CHEK FLEXLINK
FDA Adverse Event
Malfunction
·ROCHE HEALTH SOLUTIONS INC.·Product code FPA·February 8, 2013
XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code NIQ·March 13, 2013
ACCU-CHEK SPIRIT COMBO
FDA Adverse Event
Malfunction
·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·February 8, 2011
AMBIT CONTINUOUS PUMP
FDA Adverse Event
Other
·SORENSON MEDICAL PRODUCTS·Product code FRN·February 6, 2008
EVOLUT FX DCS
FDA Adverse Event
Malfunction
·MEDTRONIC IRELAND·Product code NPT·November 10, 2025
Baylis Medical TorFlex Transseptal Guiding Sheath, Rx Only, non-pyrogenic, sterile. Product Usage: The TorFlex Transseptal Guiding Sheath kit (K102948) is a single use device consisting of three components: a sheath, a dilator, and a J-tipped guidewire. The kit is designed for safe and easy catheterization and angiography of specific heart chambers and locations.
FDA Recall
Terminated
·Baylis Medical Corp 5959 TransCanada Highway Montreal Canada·Product code DYB·September 23, 2013
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K08-PI (Custom Fluid Management Kit), REF: K08-02042 K08-02948 K08-03026 K08-03119 An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein.
FDA Recall
Open, Classified
·Merit Medical Systems, Inc.·Product code OJA·June 11, 2024
Baylis Medical TorFlex Transseptal Guiding Sheath, Rx Only, non-pyrogenic, sterile. Product Usage: The TorFlex Transseptal Guiding Sheath kit (K102948) is a single use device consisting of three components: a sheath, a dilator, and a J-tipped guidewire. The kit is designed for safe and easy catheterization and angiography of specific heart chambers and locations.
FDA Enforcement
Class I
·Terminated·Baylis Medical Corp *·November 13, 2013
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K08-PI (Custom Fluid Management Kit), REF: K08-02042 K08-02948 K08-03026 K08-03119 An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein.
FDA Enforcement
Class II
·Ongoing·Merit Medical Systems, Inc.·August 21, 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
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 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