16 results
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18ms
·
Sources: EU EUDAMED, US FDA
EQUATE(TM) AQR APO AL/B DUO CONTROL
FDA 510(k)
FDA Class 2
·Immunology
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668113899·VISCO INJECTION CANNULA 26GA
MBCP+
FDA 510(k)
FDA Class 2
·Dental
SMARTFLOW, MODEL SFIP 2000
FDA 510(k)
FDA Class 2
·Cardiovascular
11MM/125 DEG TI CANN TFNA 440MM/RIGHT - STERILE
FDA Adverse Event
Injury
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HSB·April 14, 2020
SYRINGE S2 5ML 23GA 1-1/4IN BD CHINA
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·January 7, 2021
ADULT BREATHING CIRCUIT DUAL HEATED
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE, LTD.·Product code BTT·June 15, 2007
SYRINGE S2 5ML 23GA 1-1/4IN BD CHINA
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·November 12, 2020
INFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·June 30, 2014
CHARGING SYSTEM
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·January 2, 2013
ASR ACETABULAR CUPS 46
FDA Adverse Event
Injury
·DEPUY INT'L, LTD.·Product code KWA·November 17, 2010
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMN SET W/15 DROP, ULTRAPORT,134 IN.; Catalog Number: 490312. 2. IV ADMIN SET W/ 15 DROPS/ML, 120 IN.; Catalog Number: 490432.
FDA Enforcement
Class II
·Ongoing·B Braun Medical Inc·December 3, 2025
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMN SET W/15 DROP, ULTRAPORT,134 IN.; Catalog Number: 490312. 2. IV ADMIN SET W/ 15 DROPS/ML, 120 IN.; Catalog Number: 490432.
FDA Recall
Open, Classified
·B Braun Medical Inc·Product code FPA·October 29, 2025
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·March 27, 2024
paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·October 2, 2024