16 results · 18ms · Sources: EU EUDAMED, US FDA

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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