17 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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EZYPRO ECG Recorder (Model: UG02)
FDA 510(k)
FDA Class 2
·Cardiovascular
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772777501·LUMBAMED PLUS FLEX PAD M SILVER III
OC-Auto
FDA UDI
POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC·00816917026633·OC-Auto SENSOR io Personal Use Kit for VA Colum...
OC-Auto
FDA UDI
POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC·00816917021447·Personal Use Kit OC-Auto, for Columbus, OH
4CIS Chiron Spinal Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
POWDERED LATEX SURGICAL GLOVES STERILE, STERILE WITH PROTEIN CONTENT LABELING CLAIM
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY (WITH T:CONNECT MOBILE APP)
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·June 24, 2024
PORTEX BLUSELECT DILATION TRACHESTOMY KIT
FDA Adverse Event
Malfunction
·SMITHS MEDICAL INTERNATIONAL, LTD.·Product code BTO·July 18, 2022
CODEMASTER XL+
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code LDD·October 3, 2014
ASR ACETABULAR CUPS 60
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·August 12, 2011
GOBED II
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·July 9, 2013
CustMbite, Model Number CBT-SRS-UL
FDA Enforcement
Class II
·Ongoing·Dental Choice Holding Llc·August 10, 2022
VALLEYLAB
FDA Adverse Event
Malfunction
·COVIDIEN·Product code GEI·December 11, 2025
INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code PKL·June 7, 2023
OT ULTRA2 METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 1, 2016
INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code PKL·June 8, 2023
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