10 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ZinRom Nitrile examination gloves
FDA 510(k)
FDA Class 1
·General Hospital
BELIFU
FDA Adverse Event
Injury
·HONG QIANGXING (SHEN ZHEN) ELECTRONICS LIMITED·Product code GZJ·February 10, 2020
PLUS CANCELLOUS BONE SCREWS
FDA 510(k)
FDA Class 2
·Orthopedic
OASYS SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 5, 2025
PUMP MMT-522NAP PRDGM INS V2.2 PL EN
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code LZG·October 23, 2008
ASR 300 SPIKED CUP SIZE 52
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·August 10, 2011
GYNECARE TVT SECUR SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code PAH·July 8, 2013
PERITONEAL CATHETER
FDA Adverse Event
Injury
·COVIDIEN MFG SOLUTIONS S.A.·Product code FJS·May 19, 2021
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