16 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Inset Reverse Total Shoulder System
FDA 510(k)
FDA Class 2
·Orthopedic
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772777501·LUMBAMED PLUS FLEX PAD M SILVER III
Anti-K (KEL1)
FDA UDI
DIAGAST·23661562105339·Blood Grouping Reagent, Anti-K (Human/Murine Mo...
ELMED
FDA UDI
ELMED INCORPORATED·00842180107342·5 MM DIA., 45 CM INSULATED J-HOOK ELECTRODE, SI...
NA
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295086642·CANAL REAMER 9.5mm DIA
STRYKER PATIENT SPECIFIC CUTTING GUIDE
FDA 510(k)
FDA Class 2
·Orthopedic
BIOSLING - BIOABSORBABLE POLYMER SLING & SURGICAL MESH
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
22 G X 0.75 IN. BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM
FDA Adverse Event
Injury
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FOZ·August 29, 2017
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 22, 2024
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 5, 2025
T-PAL SPACER APPLICATOR HANDLE
FDA Adverse Event
Malfunction
·SYNTHES HAGENDORF·Product code LXH·October 29, 2014
PREVENA INCISION MANAGEMENT SYSTEM
FDA Adverse Event
Injury
·KCI USA, INC.·Product code OMP·August 10, 2011
ELLIPSE DR, DF-4 CONNECTOR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 8, 2013
CURRENT HEALTH MONITORING SYSTEM GEN 2 (G2)
FDA Adverse Event
Death
·CURRENT HEALTH LTD·Product code MSX·September 9, 2024
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