10 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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RAPITEX(R) RF NEW
FDA 510(k)
FDA Class 2
·Immunology
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450053195·
EZLASE 3 LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MAGNET RETRIEVAL CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
UNKNOWN DEPUY ASR FEMORAL HEAD
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD.·Product code KXA·June 30, 2014
INTEGRATED APD SET W/CASSETTE3-PRONG
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·November 20, 2010
DOSI-FLOW 30
FDA Adverse Event
Malfunction
·VICTUS·Product code FPA·December 28, 2012
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog numbers: 1. IV ADMIN SET, 10 DROPS/ML, 144 IN; Catalog Number: 490385. 2. IV ADMIN SET, 3 CARESITES, 120 IN.; Catalog Number: 490401.
FDA Enforcement
Class II
·Ongoing·B Braun Medical Inc·December 3, 2025
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog numbers: 1. IV ADMIN SET, 10 DROPS/ML, 144 IN; Catalog Number: 490385. 2. IV ADMIN SET, 3 CARESITES, 120 IN.; Catalog Number: 490401.
FDA Recall
Open, Classified
·B Braun Medical Inc·Product code FMG·October 29, 2025
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