12 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DENU Composite Resin, DENU Flow Resin
FDA 510(k)
FDA Class 2
·Dental
CD-Chex CD34
FDA UDI
STRECK, INC.·00844509000501·A positive procedural control for enumerating C...
PERMANENT PACING LEAD W/POLARIS COATED TIPS, VARIOUS MODELS
FDA 510(k)
FDA Class 3
·Cardiovascular
ORTHOLOC 3DSI LOCKING SCREWS
FDA 510(k)
FDA Class 2
·Orthopedic
530G INSULIN PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·October 25, 2014
ASR ACETABULAR CUPS 54
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·August 12, 2011
GREENLIGHT HPS LASER SYSTEM
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS·Product code GEX·July 3, 2013
CustMbite, Model Number CBT-SRS-UL
FDA Enforcement
Class II
·Ongoing·Dental Choice Holding Llc·August 10, 2022
Allura Xper FD10/10; Catalog numbers: (1) 722005, (2) 722011, (3) 722027.
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 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
DRX Revolution Mobile X-Ray System
FDA Enforcement
Class II
·Ongoing·Carestream Health, Inc.·December 13, 2023
ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026