19 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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HA-TI (HAND TITANIUM SCREW) IMPLANT
FDA 510(k)
FDA Class 2
·Dental
ZEVO™ Anterior Cervical Plate System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00763000663629·PLATE 3003045 ZEVO 45MM 3 LVL
Premier Carvers
FDA UDI
PREMIER DENTAL PRODUCTS COMPANY·00348783009156·CARVER DE LARGE DIS/CLE
ZEVO™ Anterior Cervical Plate System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169330061·PLATE 3003045 ZEVO 45MM 3 LVL
ADVANCE®
FDA UDI
Microport Orthopedics Inc.·M684K00530451·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450334218·
FacetFuse®
FDA UDI
SPINEFRONTIER, INC.·00190361019930·Facet Screw Assy, SOTW, 4.5 x 45mm
MULTI PURPOSE FLEX ARRAY COIL : MODEL 235 SERIES
FDA 510(k)
FDA Class 2
·Radiology
POSITUBE
FDA 510(k)
FDA Class 2
·Anesthesiology
MultiPolar®
FDA UDI
Zimmer, Inc.·00889024116009·
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 14, 2013
TRAUMA TRANSTAR STRETCHER
FDA Adverse Event
Malfunction
·HILL-ROM INC.·Product code FPO·February 8, 2011
2250051-2008-00090
FDA Adverse Event
Malfunction
·Product code JTC·February 11, 2008
BENCHMARK GX, STAINER MODULE
FDA Adverse Event
Malfunction
·VENTANA MEDICAL SYSTEMS INC.·Product code KPA·June 12, 2024
ZEVO¿ ANTERIOR CERVICAL PLATE SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWQ·May 21, 2021
PACKAGE,500P,PP03,INTL EN,500-BAS-SP-10
FDA Adverse Event
Malfunction
·HEARTSINE TECHNOLOGIES LTD·Product code MKJ·February 1, 2018
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
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-35; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024