20 results
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36ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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T-Edge 10, T-Edge 11
FDA 510(k)
FDA Class 2
·General Hospital
MaXcess
FDA UDI
Nuvasive, Inc.·00887517189165·MaXcess Access Blade, 80mm Center
Vitique
FDA UDI
DMG Chemisch-Pharmazeutische Fabrik GmbH·EDMG2130801·Cementation system for definitive cementation o...
PILLING
FDA UDI
TELEFLEX INCORPORATED·24026704514780·
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668113752·GIANNETTI POST CAPS CANNULA
Mariner Deformity
FDA UDI
Seaspine Orthopedics Corporation·10889981298319·Iliac Tap, Cannulated, Navigated, 8.0mm
REAADS ANTI-BETA 2 GLYCOPROTEIN I IGG TEST KIT
FDA 510(k)
FDA Class 2
·Immunology
TUBALGATOR
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
I-STAT 6+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code JGS·September 28, 2021
JAGTOME SPHINCTEROTOME
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KNS·October 23, 2008
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 16, 2011
NUBUVATOR BATH BLISS RECLINING BATH LIFT
FDA Adverse Event
Malfunction
·HANDICARE·Product code FSA·July 1, 2013
INTROCAN SAFETY® 3
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FOZ·February 20, 2026
INTROCAN SAFETY® 3
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FOZ·January 23, 2026
INTROCAN SAFETY® 3
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FOZ·June 25, 2025
ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER
FDA Adverse Event
Injury
·MEDTRONIC CRYOCATH LP·Product code OAE·August 31, 2017
INTROCAN SAFETY® 3
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FOZ·January 23, 2026
INTROCAN SAFETY® 3
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FOZ·January 29, 2026
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