17 results
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19ms
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Sources: EU EUDAMED, US FDA
SURGICAL RETENTION BAR
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
VuePoint
FDA UDI
Nuvasive, Inc.·00887517174598·VuePoint Guide, 16mm Drill
Nexalin
FDA UDI
NEXALIN TECHNOLOGY·B788KS02001·Patient cable for transcranial electrical stimu...
Rampart One Lumbar Interbody Fusion System
FDA UDI
SPINEOLOGY INC.·M7404902001·Rampart One Trial, 10.5mm, S, 8°
NA
FDA UDI
Conmed Corporation·10848584045459·ULPA/CHARCOAL FILTER CATRIDGES
DISPOSABLE LASER SPONGE SURGIMEDICS, 902001-000
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
BREEZE SLEEPGEAR WITH DREAMSEAL
FDA 510(k)
FDA Class 2
·Anesthesiology
MODIFICATION TO RENASYS EZ PLUS NEGATIVE PRESSURE WOUND THERAPY
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ESTEEM
FDA Adverse Event
Injury
·ENVOY MEDICAL CORP.·Product code OAF·December 15, 2017
DRILL BIT Ø2 W/DOUBLE MARKING L140/115 3
FDA Adverse Event
Malfunction
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HTW·March 20, 2018
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·INVAMEX·Product code IOR·June 30, 2014
ASAHI PROWATER PTCA GUIDE WIRE
FDA Adverse Event
Injury
·ABBOTT VASCULAR - CARDIAC THERAPIES·Product code DQX·November 12, 2010
AUTOPULSE NIMH BATTERY
FDA Adverse Event
Malfunction
·ZOLL CIRCULATION, INC.·Product code DRM·November 8, 2012
ULTRACISION HARMONIC ACE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·July 15, 2016
DORO¿ Easy-Connect Navigation Adaptor; BRAINLAB (item No. 1204.002)
FDA Enforcement
Class II
·Ongoing·Pro-Med Instruments Gmbh·June 4, 2025
SmartPath to dStream for 1.5T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781260
FDA Enforcement
Class II
·Completed·Philips North America Llc·September 15, 2021
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