15 results
·
25ms
·
Sources: EU EUDAMED, US FDA
CHRONO-LOG WHOLE BLOOD AGGREGOMETER, MODELS 591A AND 592A
FDA 510(k)
FDA Class 2
·Hematology
ACE
FDA UDI
ACE SURGICAL SUPPLY CO., INC.·00614950026548·LATEX TUBING 3/16"X1/16" BLACK 50' RL NS W/L
Baltic Denture System BD Load
FDA UDI
Merz Dental GmbH·D7091032951·Baltic Denture System BDLoad ↓ Ln6 PLSEum4DFl C...
Lip Bumper
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746156908·FIXED FUNCT LIP BUMPER 045 90MM BALL CLASP HK D...
MAGELLAN VENTILATOR
FDA 510(k)
FDA Class 2
·Anesthesiology
APN-2 USA SERIES FLEXIBLE CHOLEDOCHOSCOPE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BD ULTRA-FINE¿ INSULIN SYRINGE 1/2 ML, 29G
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·December 5, 2016
AMI
FDA Adverse Event
Other
·AIRWAY MANAGEMENT INC.·Product code LRK·July 10, 2013
UNKNOWN GLENOID
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·November 22, 2022
CONSTELLATION VISION SYSTEM
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·April 1, 2013
SPRINT QUATTRO SECURE
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·March 29, 2011
DEPUY
FDA Adverse Event
Injury
·DEPUY INC·Product code KWB·April 11, 2008
UNKNOWN HUMERAL HEAD
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·November 22, 2022
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
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024