17 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MediExpand Cervical Expandable VBR System
FDA 510(k)
FDA Class 2
·Orthopedic
LuxaCore® Automix Dual
FDA UDI
DMG Chemisch-Pharmazeutische Fabrik GmbH·EDMG2121260·Core build-up composite. Core buildups and post...
NA
FDA UDI
Synthes GmbH·10886982152008·3.5MM LOCKING SCREW SLF-TPNG WITH STARDRIVE REC...
Tissue Holder
FDA UDI
KATENA PRODUCTS, INC.·00841668111192·STEEL BASE FOR BARRON AAC
Posterior Pelvic Wall Plate, Left
FDA UDI
I.T.S. GmbH·09120047302248·Posterior Pelvic Wall Plate, Left, 6-Hole, PRS ...
GENUINE FIRST AID CPR MASK
FDA 510(k)
FDA Class 2
·Anesthesiology
THE SALICEPT ORAL PATCH
FDA 510(k)
FDA Unclassified
·Unknown
BD LUER-LOK
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·December 16, 2025
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·October 29, 2014
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·August 15, 2011
PRIME ZOOM STRETCHER, ELECTRIC
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code INK·July 8, 2013
FLEXOR SHUTTLE GUIDING SHEATH
FDA Adverse Event
Injury
·COOK INC·Product code DYB·August 2, 2016
FLEXOR SHUTTLE GUIDING SHEATH
FDA Adverse Event
Injury
·COOK INC·Product code DYB·August 2, 2016
FLEXOR SHUTTLE GUIDING SHEATH
FDA Adverse Event
Injury
·COOK INC·Product code DYB·August 5, 2016
Allura Xper FD10/10; Model Numbers: (1) 722005, (2) 722011, (3) 722027; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 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
BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 15, 2021