13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OverStitch Sx Endoscopic Suturing System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
300XL, HERMES
FDA UDI
Smith & Nephew, Inc.·03596010589057·KIT 300XL HERMES INTL
NA
FDA UDI
Smith & Nephew, Inc.·03596010448262·RAKE RETRACTOR 60.3 WIDEX50.8 DEEP
...
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319744840·Rees (Gubisch) Nasal Osteotome 200mm, 8" (20cm)...
Radius Plate PROlock, Wide
FDA UDI
I.T.S. GmbH·09120034303197·Radius Plate PROlock, Wide, 6-Hole, Left
MAC 5500 HD, MAC 3500
FDA 510(k)
FDA Class 2
·Cardiovascular
TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST, CATALOG #98000
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 5, 2025
ACTIVA
FDA Adverse Event
Malfunction
·NEURO - VILLALBA·Product code MHY·October 29, 2014
ECHELON 45 ENDOPATH STAPLER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC·Product code GDW·October 21, 2008
MINICAP
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·July 8, 2013
ACHIEVE ADVANCE MAPPING CATHETER
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code DRF·May 1, 2025
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