12 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SIMULTEST IMK PLUS(TM)
FDA 510(k)
FDA Class 2
·Hematology
Multipac UniFlow anesthesia breathing system
FDA UDI
Intersurgical Incorporated·00816472022965·Multipac® UniFlow anesthesia breathing system, ...
Barricade Coil System
FDA UDI
BALT USA LLC·00818053020773·Barricade Coil System (BCS) is intended for the...
CUSTOMED
FDA UDI
CUSTOMED INC·M2089000782·STERILIZATION WRAPPER DISPOSABLE 10" X 10"
Master Series
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746094675·DB BKT MASTER LR CUSP 022 T-11 A+7 R=0
JETLITE 4000
FDA 510(k)
FDA Class 2
·Dental
KERASYS BIOENGINEERED LAMELLAR PATCH GRAFT
FDA 510(k)
FDA Class 2
·Ophthalmic
UV FLASH TRANSFER SETS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·January 7, 2013
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·January 14, 2014
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·November 12, 2010
Animas(R) 2020 Insulin Infusion Pump Product Usage: This product is indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes.
FDA Enforcement
Class I
·Terminated·Animas Corporation·April 10, 2013
TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021