12 results
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23ms
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Sources: EU EUDAMED, US FDA
Blustone Synergy Diamond SA Cervical System
FDA 510(k)
FDA Class 2
·Orthopedic
PMT CORPORATION - STEREOTACTIC
FDA UDI
PMT CORPORATION·00650551068358·BRW/CRW-sEEG KIT: 2103-17, 2103-34 (QTY 2), 210...
100 SERIES OXYGEN ANALYZER, MODELS 1000-E AND 1000-I
FDA 510(k)
FDA Class 2
·Anesthesiology
BTL-703-2
FDA 510(k)
FDA Class 2
·Physical Medicine
MEDLINE UNITE
FDA Adverse Event
Injury
·MEDLINE INDUSTRIES, LP·Product code JDR·December 23, 2025
I-STAT EC8+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code CHL·September 14, 2021
PROGRAMMING SOFTWARE
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·October 29, 2014
LOW VOLUME W/ BVM BLOODLINE
FDA Adverse Event
Injury
·REYNOSA MANUFACTURING·Product code FJK·August 8, 2011
ENDOTAK RELIANCE
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NVY·July 8, 2013
ACUSON S Family Ultrasound Systems at software versions VC25D, VC30A and VC30B; (S2000, S3000 and S1000 systems) Siemens Medical Solutions USA, Inc. Ultrasound imaging systems.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·July 9, 2014
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021
ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017 S 2000 system 10441730 S 3000 system 10441701 S 1000 system 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.·August 5, 2015