24 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Cito CBC System
FDA 510(k)
FDA Class 2
·Hematology
CoRoent
FDA UDI
Nuvasive, Inc.·00887517631145·CoRoent Ant TLIF Ti, 14x10x40mm 12°
Ultra-Care Insulin Syringe 30G 5/16" 0.5 CC 100 Ct
FDA UDI
ARISE MEDICAL LLC·00372217007043·Ultra-Care Insulin Syringe 30G 5/16" 0.5 CC 100 Ct
Holder, Needle, TC, acc. Lemmon 19.5cm
FDA UDI
Geister Medizintechnik GmbH·04057034066331·Holder, Needle, TC, acc. Lemmon
19.5cm...
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776300036·10mm 29cm Bugge Suction, medium
ANGIODYNAMICS, INC. MORE-FLOW HEMODIALYSIS CATHETER AND PROCEDURE KIT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MEDSOURCE IV ADMINISTRATION SET 72 MEDSOURCE IV ADMINISTRATION SET, NEEDLELESS MALE ADAPTER, MEDSOURCE IV EXTENSION SET
FDA 510(k)
FDA Class 2
·General Hospital
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 28, 2025
AUTOPULSE NXT QUICK CASE
FDA Adverse Event
Injury
·ZOLL CIRCULATION, INC.·Product code DRM·April 9, 2025
OMNIPOD INSULIN PUMP
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code LZG·February 1, 2013
S-ICD SYSTEM
FDA Adverse Event
Injury
·CAMERON HEALTH·Product code NVY·October 30, 2014
CPS COURIER
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DQY·September 9, 2011
4MM FLUTED BALL
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBC·July 17, 2013
BIOMET StageOne, Shoulder Cement Spacer Mold 14 MM, 58 X 24 X 64 MM, Silicone, Sterile, Item 431414.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
EasyPoint Needle, 25G x 5/8", REF: 82091
FDA Enforcement
Class II
·Ongoing·Retractable Technologies, Inc.·March 20, 2024
Brand Name: Novasight Hybrid System Product Name: Novasight Hybrid Catheter Model/Catalog Number: TA-06-0001 Product Description: Common Name: Diagnostic intravascular catheter Description: The Novasight Hybrid catheter is a 3Fr single use, sterile device, which will be able to perform transluminal ultrasound and optical coherence tomography imaging of adults. The catheter is capable of real-time 2D side viewing ultrasound and optical imaging acquired simultaneously providing precisely co-registered images with the ability to produce rapidly post processed rendered longitudinal images of the vessel. Packaging: The Novasight Hybrid Catheter is packaged in a packaging system including the protective packaging and the sterile barrier system.
FDA Enforcement
Class I
·Ongoing·Conavi Medical Inc.·April 30, 2025
BIOMET StageOne Knee Femoral Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 432175.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 9 X 125 MM, 43 MM, Silicone, Sterile, Item 431207.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
BIOMET StageOne Knee Tibial Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 433175.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
BIOMET StageOne Knee Tibial Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 433165.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020