15 results · 25ms · Sources: EU EUDAMED, US FDA

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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