16 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VENTSTAR HEATED, INFINITY ID BREATHING CIRCUIT HEATED
FDA 510(k)
FDA Class 2
·Anesthesiology
Oticon
FDA UDI
Oticon A/S·05707131160508·SAFARI 900, BTE 13 P TC
Carbide burs
FDA UDI
DFS - DIAMON GmbH·04057176153173·Carbide 2 FG 1,8 mm
Plateau Spacer System
FDA UDI
Life Spine, Inc.·00190837026301·PLATEAU Interbody, Straight, Bulleted, 10mm 26m...
PLATEAU-TL
FDA UDI
Life Spine, Inc.·00190837028428·PLATEAU-TL Interbody, Convex, Bulleted, 10mm x ...
MAXLOCK EXTREME EXTREMITY PLATING SYSTEM WITH VARIABLE ANGLE TECHNOLOGY
FDA 510(k)
FDA Class 2
·Orthopedic
NORIAN REINFORCED, NORIAN REINFORCED FAST SET PUTTY
FDA 510(k)
FDA Class 2
·Neurology
NORIAN REINFORCED FAST SET PUTTY/3CC
FDA Adverse Event
Malfunction
·SYNTHES SELZACH·Product code GXP·May 19, 2015
RADIOLUCENT INSERTION HANDLE FOR EXPERT NAILS/100MM
FDA Adverse Event
Malfunction
·SYNTHES HAGENDORF·Product code LXH·March 1, 2017
DREAMSTATION CPAP PRO
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·November 2, 2022
RESTORE ULTRA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·May 9, 2013
LC PCA III INFUSER
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code MEA·August 28, 2014
RESTORE ULTRA
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·May 23, 2011
KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Size 3 / Child Silicone King LAD¿ Patient Size: 30-50kg Product Usage: Laryngeal airway
FDA Enforcement
Class II
·Terminated·King Systems Corp.·November 28, 2012
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025