14 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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First Relief v1
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Blade Scalpel
FDA UDI
KATENA PRODUCTS, INC.·00841668113448·SUPER SHARPS 15 DEG 3MM (BX/5)
OsteoMed
FDA UDI
OSTEOMED LLC·00845694090780·ExtremiLOCK Ankle Case, Reduced
Blade Scalpel
FDA UDI
KATENA PRODUCTS, INC.·00841668113561·IMPLANT BLADE 6.2MM (BX/5)
VASCOPRESS SEQUENTIAL DVT PUMP
FDA 510(k)
FDA Class 2
·Cardiovascular
IN-VISION VIEW WITH MEASUREMENTS MODULE, MODEL 1.0
FDA 510(k)
FDA Class 2
·Radiology
PUMP MMT-522LNAL PRDGM INS CL EN ML
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code LZG·October 15, 2008
ENRHYTHM DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code DXY·August 11, 2011
PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code LKK·July 2, 2013
NSK
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code EGS·May 28, 2023
XP-XP Tibial Tray - Interlok 69 mm Item # 195754
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·September 18, 2019
BIOMET StageOne Knee Tibial Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 433175.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012
Model Number L211 PROPONENT DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025