18 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SYNCHRON CONTROL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
GEN4 DIGITAL
FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828109215·GEN4 DIGITAL
LIFEPAK® 12 defibrillator/monitor
FDA UDI
PHYSIO-CONTROL, INC.·00885074855677·LP12AABCAAAACAABAAAAAAAALP12 MONITOR-DEFIB
VITAL SHIELD GOLD NON-STERILE POWDERED LATEX EXAM GLOVES BLUE, WITH AND/OR WITHOUT BUBBLEGUM SCENT, AND WITH PROTEIN LAB
FDA 510(k)
FDA Class 1
·General Hospital
NARKOMED MRI , NM-MRI
FDA 510(k)
FDA Class 2
·Anesthesiology
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code NKB·November 11, 2020
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code NKB·November 11, 2020
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code NKB·October 8, 2020
HOLDING SLEEVE-LONG
FDA Adverse Event
Malfunction
·SYNTHES (USA)·Product code LXH·February 28, 2013
OMNILINK .035 STENT DELIVERY SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code FGE·March 1, 2011
ANALYTICAL E MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·February 21, 2008
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code NKB·November 12, 2020
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code NKB·November 25, 2020
UNFOLDER EMERALD
FDA Adverse Event
Malfunction
·AMO PUERTO RICO MFG. INC.·Product code KYB·December 31, 2024
ACUVUE OASYS
FDA Adverse Event
Injury
·JOHNSON & JOHNSON VISION CARE, INC. ¿ IRELAND·Product code LPM·May 3, 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
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