16 results · 21ms · Sources: EU EUDAMED, 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