87 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Pulmonx Chartis Tablet Console
FDA 510(k)
FDA Class 2
·Anesthesiology
Syringes with Luer Slip Tips labeled as: 1) SOL-M 1ml Slip Tip Syringe w/o Needle, Model No. 180011, UPC 8183923010138; 2) SOL-M 1ml Slip Tip Syringe w/o Needle, Model No. P180011, UPC 810018097523; 3) SOL-M 20ml Slip Tip Syringe w/o Needle, Model No. 180020ST, UPC 840368511998; 4) SOL-M 3ml Slip Tip Syringe w/o Needle, Model No. P180003ST, UPC 810018097493; 5) SOL-M 5ml Slip Tip Syringe w/o Needle, Model No. P180005ST, UPC 810018097462; 6) SOL-M 10ml Slip Tip Syringe w/o Needle, Model No. P180010ST, UPC 810018097646; 7) SOL-M 20ml Slip Tip Syringe w/o Needle, Model No. P180020ST, UPC 810018098636; 8) SOL-M 30ml Slip Tip Syringe w/o Needle, Model No. P180030ST, UPC 810062435333; 9) SOL-M 60ml Slip Tip Syringe w/o Needle, Model No. P180060ST, UPC 810062435340; 10) SOL-M 1ml Slip Tip Syringe Sterile Convenience Tray, Model No. P180011T, UPC 810018098957
FDA Enforcement
Class II
·Ongoing·Sol-Millennium Medical Inc.·September 18, 2024
OsteoMed
FDA UDI
OSTEOMED LLC·00845694044875·DuraKnife, Sterile
NIDO Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07315K1100110·Tray Insert, Rod Connectors
Kalitec Special
FDA UDI
Kalitec Direct LLC·B073DRK1200110·Rod Gripper, 5.50mm Angled
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K1100110·Tray Insert 4, Cosmolock, Arcamed
HEISENBERG EFFECT SHADES
FDA 510(k)
FDA Class 2
·Dental
FISHER & PAYKEL HEALTHCARE BUBBLE CPAP SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
Syringes with Luer Slip Tips labeled as: 1) SOL-M 1ml Slip Tip Syringe w/o Needle, Model No. 180011, UPC 8183923010138; 2) SOL-M 1ml Slip Tip Syringe w/o Needle, Model No. P180011, UPC 810018097523; 3) SOL-M 20ml Slip Tip Syringe w/o Needle, Model No. 180020ST, UPC 840368511998; 4) SOL-M 3ml Slip Tip Syringe w/o Needle, Model No. P180003ST, UPC 810018097493; 5) SOL-M 5ml Slip Tip Syringe w/o Needle, Model No. P180005ST, UPC 810018097462; 6) SOL-M 10ml Slip Tip Syringe w/o Needle, Model No. P180010ST, UPC 810018097646; 7) SOL-M 20ml Slip Tip Syringe w/o Needle, Model No. P180020ST, UPC 810018098636; 8) SOL-M 30ml Slip Tip Syringe w/o Needle, Model No. P180030ST, UPC 810062435333; 9) SOL-M 60ml Slip Tip Syringe w/o Needle, Model No. P180060ST, UPC 810062435340; 10) SOL-M 1ml Slip Tip Syringe Sterile Convenience Tray, Model No. P180011T, UPC 810018098957
FDA Recall
Open, Classified
·Sol-Millennium Medical Inc.·Product code FMF·May 9, 2024
NEONATAL BUBBLE CPAP DUAL HEATED CIRCUIT KIT
FDA Adverse Event
Malfunction
·Product code BZE·March 3, 2021
Stent, Superficial Femoral Artery, Drug-Eluting
FDA Pre-Market Approval
FDA Class 3
·Eluvia Drug-Eluting Vascular Stent System
BUBBLE CPAP CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BZD·April 19, 2011
ARCAD EXPRESS
FDA Adverse Event
Injury
·NOVASTEP·Product code JDR·June 26, 2019
BUBBLE CPAP CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BZD·April 19, 2011
LAMITRODE TRIPOLE 16C
FDA Adverse Event
Injury
·ST. JUDE MED - NEUROMODULATION·Product code GZB·October 15, 2014
SYSTEM, PERITONEAL AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·June 20, 2013
NX3 DUAL CURE CLEAR
FDA Adverse Event
Injury
·KERR CORPORATION·Product code EMA·July 27, 2011
Stent, Superficial Femoral Artery, Drug-Eluting
FDA Pre-Market Approval
FDA Class 3
·Eluvia Drug-Eluting Vascular Stent System
Stent, Superficial Femoral Artery, Drug-Eluting
FDA Pre-Market Approval
FDA Class 3
·Eluvia Drug-Eluting Vascular Stent System
Stent, Superficial Femoral Artery, Drug-Eluting
FDA Pre-Market Approval
FDA Class 3
·Eluvia Drug-Eluting Vascular Stent System