15 results
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19ms
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Sources: EU EUDAMED, US FDA
SECU-TAPE UNIVERSAL FLEXIBLE MEDICAL CLAMPS
FDA 510(k)
FDA Class 1
·General Hospital
Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78505031·Sprint II Bracket Roth .018" max. 4+5 left w. hook
Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78505030101·Sprint II Bracket Roth .018" max. 4+5 left w. hook
Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78505031001·Sprint II Bracket Roth .018" max. 4+5 left w. hook
Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78505030051·Sprint II Bracket Roth .018" max. 4+5 left w. hook
Echo Bi-Metric Microplasty Line Extension
FDA 510(k)
FDA Class 2
·Orthopedic
SINGLE USE ASPIRATION NEEDLE NA-201SX-4022
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
STYLE 15 SILICONE GEL FILLED BREAST IMPLANT
FDA Adverse Event
Injury
·ALLERGAN (COSTA RICA)·Product code FTR·January 21, 2020
STRYKEFLOW 2
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY·Product code GEI·May 28, 2014
BOLSA VACIA 3L EVA TRES VIAS DE TRANSFERENCIA CON DESCONEXIO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - CALI·Product code BTC·October 1, 2010
PINNACLE MTL INS NEUT36IDX54OD
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·November 29, 2012
8100 ALARIS PUMP MODULE
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·January 8, 2021
8100 ALARIS PUMP MODULE
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·January 8, 2021
Product Description/Item: ChemoLock Vial Spike, 20mm/011-CL-80S; ChemoLock Bag Spike/CL-10; ChemoLock w/Mini Bag Spike/CL-17; 8 IN (20cm) APPX 1.0ml, EXT SET, MicroClave Clear, ChemoLock PORT, YCONN/CL3950; 31" (79 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros, Purple Cap, Hanger/CL3951; 7.5" (19 cm) Appx 1.5 ml, Ext Set w/ChemoLock Port, Clamp, Graduated Adapter/CL3967; 6 IN(15cm)APPX 0.82ml,EXT SET,MicroClave Clear,ChemoLock PORT,YCONN, ROTATING LUER/CL4118; ChemoLock Kit w/ 5" (13 cm) Bag Spike Adapter w/ChemoLock w/Red Cap, Vented Cap, ChemoLock Port Bag Spike/CL4158; ChemosafeLock Bag Spike/KL-BS001U3; ChemosafeLock Vial Adapter/KL-VA201U3; ChemosafeLock Vial Adapter/KL-VA202U3; ChemosafeLock Vial Adapter/KL-VA321U3; ChemosafeLock Vial Adapter/KL-VA322U3; ChemoLock Vented Vial Spike/011-CL-51; Transfer Set, PUR Yellow w/ChemoLock Port, Spiros/011-CL4155; Puerto ChemoLock/034-CL2100; ChemoLock, Punzon Univ. Vial c/ Filtro, fijacion/034-CL-70; ChemoLock, Punzon Vial Tritan c/ Filtro, 13mm/034-CL-72
FDA Enforcement
Class II
·Ongoing·ICU Medical, Inc.·September 14, 2022
Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.
FDA Enforcement
Class II
·Terminated·STERILMED, INC.·December 16, 2015