13 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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THD BANDY
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450506325·
FAS SET #4551
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
DISPOSABLE PRESSURE MONITOR
FDA 510(k)
FDA Class 2
·Anesthesiology
ROUND FILTER POLYPROVPYLENE
FDA Adverse Event
Malfunction
·SPS MEDICAL SUPPLY CORP·Product code FRG·June 25, 2013
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·February 18, 2026
FOOTPRINT ULTRA PK SUTURE ANCHOR, 4.5
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code MBI·August 4, 2015
FOOTPRINT ULTRA PK SUTURE ANCHOR, 4.5
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code MBI·July 28, 2015
EXPRESS¿ VASCULAR SD
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code FGE·May 6, 2013
INFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code FRN·September 16, 2014
GREENLIGHT ADDSTAT
FDA Adverse Event
Malfunction
·AMS, INNOVATION CTR - SILICON VALLEY·Product code GEX·April 6, 2011
Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, RIGHT, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-02-32, b) 41, 44, 47, 50 head, Medium, Item Number 314-02-33, c) 44, 47, 50, 53 head, Large, Item Number 314-02-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-02-35; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
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