12 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)
FDA 510(k)
FDA Class 2
·Neurology
NA
FDA UDI
Medos International Sàrl·10886705003501·REUSABLE OBTURATOR 5.5 x 90mm
PMT® Halo Systems
FDA UDI
PMT CORPORATION·00650551114420·HALO, CTLSO VEST SMALL, COOLMAX LINER, 1211-1 X...
ALEUTIAN® Interbody Systems
FDA UDI
VB Spine LLC·10888857522336·Trial Size 13x16x6 mm, 15°
ANCHOR BOLT NUT
FDA UDI
Biomet Orthopedics, LLC·00887868024139·
Tandry Locking Plate System
FDA UDI
MICROWARE PRECISION CO., LTD.·04719873094554·Cortex Screw 1.5mm, 9mm, Hexalobular
visor2 system
FDA 510(k)
FDA Class 2
·Neurology
IN-TIME RETRIEVAL DEVICE
FDA 510(k)
FDA Class 2
·Cardiovascular
MAYFIELD MODIFIED SKULL CLAMP
FDA Adverse Event
Other
·INTEGRA, CINCINNATI·Product code HBL·July 20, 2011
TRILOGY LONGEVITY CONSTRAINED LINER
FDA Adverse Event
Malfunction
·ZIMMER, INC.·Product code KWB·October 24, 2008
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·July 9, 2013
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