10 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ARROW SELDINGER ARTERIAL CATHERIZATION DEVICES, MODELS EX SAC 00520
FDA 510(k)
FDA Class 2
·Cardiovascular
Prime
FDA UDI
C A I INDUSTRIES CORP·00807689000327·0.30x50mm acupuncture needles (10 needles with ...
CRYOSURGICAL UNIT AND ACCESSORIES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
THE BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
NV MICROCATHETER
FDA Adverse Event
Injury
·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRA·July 9, 2020
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 21, 2025
530G INSULIN PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·September 21, 2015
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·May 3, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·September 16, 2014
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