11 results · 28ms · Sources: EU EUDAMED, US FDA

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CANDELA GENTLEYAG FAMILY OF LASER SYSTEMS

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

ACE

FDA UDI
ACE SURGICAL SUPPLY CO., INC.·00614950029846·BANDAGE ACE ELASTIC 4" N-STER L/F L/F 10RL/BOX

Baltic Denture System BDLoad

FDA UDI
Merz Dental GmbH·D7091033172·Baltic Denture System BDLoad BDLoad Mw6 PLSEbi...

INSTANT-VIEW Methadone Urine Cassette Test

FDA UDI
ALFA SCIENTIFIC DESIGNS, INC.·10796918000641·INSTANT-VIEW Methadone Urine Cassette Test

SMALL HIGH SPEED MOTOR DRILL SYSTEM

FDA 510(k)
FDA Class 2 ·Neurology

PORGES SILICONE PROSTATECTOMY CATHETER, STRAIGHT CYLINDRICAL TIP, DELINOTTE TIP, DUFOUR TIP, OVER THE GUIDE TIP, MODEL

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

TOTALCARE BED

FDA Adverse Event
Malfunction ·HILL-ROM, INC.·Product code FNL·March 1, 2013

DEXTRUS 4135

FDA Adverse Event
Malfunction ·BIOTRONIK SE & CO. KG·Product code NVZ·February 28, 2011

ACCU-CHEK COMFORT CURVE TEST STRIPS

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·April 23, 2008

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