12 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RCT700
FDA 510(k)
FDA Class 2
·Radiology
ASSI
FDA UDI
ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATION·00841645119814·Castroviejo Fixation Fcps, 11cm, Wide Hdl 0.3mm...
EVENFLO COMFORT EASE MANUAL BREAST PUMP KIT
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
8MP COLOR LCD MONITOR,RADIFORCE RX840
FDA 510(k)
FDA Class 2
·Radiology
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·August 7, 2023
FREESTYLE
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC.·Product code LFR·October 11, 2006
VISERA ELITE III VIDEO SYSTEM CENTER
FDA Adverse Event
Malfunction
·SHIRAKAWA OLYMPUS CO., LTD.·Product code FET·September 6, 2025
ASR UNI FEMORAL IMPL SIZE 45
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·August 12, 2011
BD NEXIVA CLOSED IV ACCESS SYSTEM
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEM·Product code FOZ·October 22, 2008
GYNECARE PROLIFT TOTAL PELVIC FLOOR REPAIR SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTP·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
DRX Revolution Mobile X-Ray System
FDA Enforcement
Class II
·Ongoing·Carestream Health, Inc.·December 13, 2023