12 results
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18ms
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Sources: EU EUDAMED, US FDA
RUBBER, DENTAL DAM (NON-STERILE)
FDA 510(k)
FDA Class 1
·Dental
GRASPING FORCEP INSERT
FDA UDI
SONTEC INSTRUMENTS, INC.·B09929012360·GRASPING FORCEPS WITH MOUSE TEETH SINGLE-ACTION...
TCP
FDA UDI
WRIGHT MEDICAL TECHNOLOGY, INC.·00840420170255·
MANTRA COMBO, MODEL MECS 320
FDA 510(k)
FDA Class 2
·Neurology
RIZA BAND STRETCHER (RBS)-60000
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BD PLASTIPAK 50ML CONCENTRIC LUER LOCK SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·April 12, 2019
VACUETTE BLOOD COLLECTION TUBE 3ML K2E K2EDTA
FDA Adverse Event
Malfunction
·GREINER BIO-ONE NA INC.·Product code JKA·November 2, 2020
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·June 30, 2014
OPTIFLEX
FDA Adverse Event
Injury
·CHATTANOOGA GROUP INC.·Product code BXB·November 4, 2010
URETEX SUPPORT PP TRANSOBTUR2 KIT X1
FDA Adverse Event
Injury
·SOFRADIM PRODUCTION·Product code OTN·November 16, 2012
ArjoHuntleigh Contoura C1000 series beds are designed to accommodate patients weighing up to 990 lbs. (450 kg). Model C1000 is the basic bed. Model C1080 includes a weighing system and a power outlet for an ArjoHuntleigh approved mattress pump. Product Usage: The Contoura series bariatric beds are electrically operating medical beds with a maximum patient weight of 450 kg. This range is intended for use in hospitals to facilitate management of obese patients. An optional integrated weighing system helps with assessment and management of the patient if required.
FDA Enforcement
Class II
·Terminated·Arjo Hospital Equipment AB·October 15, 2014
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