15 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SILVER ALGINATE IV ANTIMICROBIAL WOUND DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
LOCATOR R-Tx
FDA UDI
Zest Anchors, LLC·00840481113437·LOCATOR R-Tx Abutment for 3.3mm Conelog Connect...
A&E Medical / Rotating Surgical Punches
FDA UDI
A & E MEDICAL CORPORATION·10841291106999·5.0 Rotating Surgical Punch, Tapered - 1 per pouch
InTess Lumbar Cage
FDA UDI
Kalitec Direct LLC·B07312K0105030·Implant Inserter, 8-10mm, Sleeveless
Clamp, Hysterectomy, model Z 21.5cm angled
FDA UDI
Geister Medizintechnik GmbH·04057034373286·Clamp, Hysterectomy, model Z
21.5cm...
AMIGO WHEELCHAIR
FDA 510(k)
FDA Class 2
·Physical Medicine
MEDART 520 COOLING SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DEXCOM ONE CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 7, 2025
PRECISION LINK
FDA Adverse Event
Malfunction
·Product code NBW·April 26, 2013
LIGHTSPEED VCT
FDA Adverse Event
Injury
·GE MEDICAL SYSTEMS LLC·Product code JAK·April 22, 2011
LIGACLIP MCA LARGE APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC·Product code GDO·July 24, 2008
RUNTHROUGH NS
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DQX·January 24, 2018
RUNTHROUGH NS
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DQX·January 30, 2018
COULTER PrepPlus and PrepPlus 2, Pipetting and Diluting station for Clinical Use
FDA Recall
Terminated
·Beckman Coulter Inc·Product code JQW·March 28, 2003
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·April 30, 2014