10 results
·
27ms
·
Sources: EU EUDAMED, US FDA
INFRAVIEW/INFRASION-TELETHERMOGRAPHIC SYSTEM
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
6844771
FDA Adverse Event
Malfunction
·September 6, 2017
ALCOHOL & AMMONIA CALIBRATOR I
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BIOTIS SEVEN H 11 AGAR
FDA 510(k)
FDA Class 1
·Microbiology
KERRISON PUNCH 130DEG UP 200M 1MM THIN
FDA Adverse Event
Malfunction
·AESCULAP AG & CO. KG·Product code LRY·March 12, 2014
HEART START XL
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·November 1, 2012
9600
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·September 23, 2010
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
Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018
Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025