11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SYNTHES OC FUSION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Equate Liquid Personal Lubricant
FDA UDI
WAL-MART STORES, INC.·00194346600809·is a personal lubricant, for penile and/or vagi...
AM-BIO EXTENDED RANGE SERIES DIALYZER, MODELS WET AND DRY
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
HEARTONE EVENT RECORDER AND TRANSMITTER
FDA 510(k)
FDA Class 2
·Cardiovascular
PREFYX PPS SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - SPENCER·Product code FTL·April 11, 2013
ACUITY CENTRAL MONITORING
FDA Adverse Event
Malfunction
·WELCH ALLYN PROTOCOL, INC.·Product code DSI·March 17, 2011
LIFEVEST WCD 3000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·May 28, 2008
FLEXOR PARALLEL URETERAL ACCESS SHEATH AND DILATORS
FDA Adverse Event
Injury
·COOK INC·Product code EZN·May 21, 2019
BACT/ALERT® SA CULTURE BOTTLE
FDA Adverse Event
Injury
·BIOMERIEUX INC.·Product code MDB·August 16, 2019
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
ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026