21 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Orchid Safety Release Valve
FDA 510(k)
FDA Class 2
·General Hospital
Meridian
FDA UDI
Seaspine Orthopedics Corporation·10889981310066·Trial Rasp, 43mm x 30mm x 14mm, 15 Deg
Meridian
FDA UDI
Seaspine Orthopedics Corporation·10889981247485·No-Profile Interbody, 43mm x 30mm x 14mm, 15 Deg
3D Printed Interbody Systems
FDA UDI
Seaspine Orthopedics Corporation·10889981304188·2-Hole No-Profile Interbody, 43mm x 30mm x 14mm...
EVA TPN CONTAINER
FDA 510(k)
FDA Class 2
·General Hospital
Vial2Bag Advanced 20mm Admixture Device
FDA 510(k)
FDA Class 2
·General Hospital
SoftTip® medium
FDA UDI
Honeywell Healthcare Solutions GmbH·04036616002387·SoftTip® medium RM-2414-15 HP/Philips
SoftTip small
FDA UDI
Honeywell Healthcare Solutions GmbH·04036616002172·SoftTip small RS-2414-15 HP/Philips
SoftTip large
FDA UDI
Honeywell Healthcare Solutions GmbH·04036616001885·SoftTip large R-2414-15 HP/Philips
FingerClip
FDA UDI
Honeywell Healthcare Solutions GmbH·04036616001014·FingerClip F-2414-15 HP/Philips
Ear sensor
FDA UDI
Honeywell Healthcare Solutions GmbH·04036616002769·Ear sensor ES-2414-15 HP/Philips
Ear sensor
FDA UDI
Honeywell Healthcare Solutions GmbH·04036616007016·Ear sensor ES-2414-15 OEM HP/Philips
FingerClip
FDA UDI
Honeywell Healthcare Solutions GmbH·04036616006583·FingerClip F-2414-15 OEM HP/Philips
GOLD PROBE?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - COSTA RICA (COYOL)·Product code KNS·November 10, 2014
PULSE GEN MODEL 102
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·August 18, 2011
OPEN SPINE CLAMP, TITANIUM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code HAW·July 22, 2013
REUSABLE ENVITEC FINGER SPO2 SENSOR-HP/PHILIPS COMPATIBLE, MODELS F-2412, F-2414-15, REUSABLE ENVITEC EAR SPO2 SENSOR
FDA 510(k)
FDA Class 2
·Cardiovascular
TMC SPEEDMTP
FDA Adverse Event
Injury
·TREACE MEDICAL CONCEPTS, INC.·Product code JDR·April 1, 2025
PKG, FIXATION CLAMP 5MM WITH RATCHET, P/N 0250080130 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
FDA Enforcement
Class II
·Terminated·Stryker Endoscopy·December 24, 2014
BioButton REF BIOST06040 with Software version 3.0.20 The BioButton System is a remote monitoring wearable device intended for continuous collection of physiological data in home and healthcare settings while the patient is at rest.
FDA Enforcement
Class II
·Ongoing·Biointellisense Inc.·August 21, 2024