12 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Varixis Elbow System
FDA 510(k)
FDA Class 2
·Orthopedic
EVOS Lumbar Interbody System
FDA UDI
Cutting Edge Spine, LLC·00841193100876·EVOS Straight HA PEEK, 14mm x 8mm x 26mm, Flat ...
Needle aspiration and injection
FDA UDI
KATENA PRODUCTS, INC.·00841668113608·PERIBULBAR NEEDLE 25GA 22MM
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0130140·Sagittal Bender, Right
BLOCK CEMENT RESTRICTOR (CR) - TITANIUM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CLAW II POLYAXIAL COMPRESSION SYSTEM AND ORTHOLOC 3DSI LOCKING SCREWS
FDA 510(k)
FDA Class 2
·Orthopedic
INTELLIS
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·January 21, 2025
DEXTRUS 4137
FDA Adverse Event
Injury
·BIOTRONIK SE & CO. KG·Product code NVZ·August 9, 2011
HEARTSINE SAMARITAN 300O AND PAD PAK
FDA Adverse Event
Malfunction
·HEARTSINE TECHNOLOGIES, LTD·Product code MKJ·September 1, 2014
TELIGEN
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 9, 2013
CORTICAL BONE SCREW, Ø3.5MM X 24MM
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code KTW·March 3, 2025
18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer 10041227 & 10789400 S1000 10441701 S2000 10041461 S2000 (Refurb) - 10440017 S3000 10441730 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·May 3, 2017