33 results
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13ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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ON-Q pump with ONDEMAND bolus button, ON-Q C-bloc with ONDEMAND; ON-Q C-bloc with Select a Flow and ONDEMAND Model/Reference #: 7000180, 7000181, 7000182, 7000367, 7000397, CB003, CB005, CB006, P400X1-7+5/60, P400X2-14+5/30, P400X5+5/60, and PMB01. Part Numbers: 101347100, 101347300, 101347400, 101360200, 101368400, 101368600, 101368700, 102987000, 102987200, 102987300, 103161800, 103534300, 5001438, 5001470, 5001651, 5001780, 5001808, 5001809, 5001812, 7000180, 7000181, 7000182, & 7000367. Indicated for continuous and or intermittent delivery of medication to or around surgical wound sites and or close proximity to nerves.
FDA Enforcement
Class I
·Terminated·I-Flow Corporation·September 5, 2012
I-Flow ON-Q Pain Relief System, T-Block Needle/Catheter Tray, Model #TBTB1089T The intended use of each component in the finished final trays is consistent with the intended use of the component stated in the respective 510(k) submission.
FDA Enforcement
Class II
·Terminated·I-Flow LLC·June 12, 2013
I-Flow ON-Q Pain Relief System, T-Block Needle/Catheter Kit, Model #TB089T The intended use of each component in the finished final trays is consistent with the intended use of the component stated in the respective 510(k) submission.
FDA Enforcement
Class II
·Terminated·I-Flow LLC·June 12, 2013
ON-Q PainBuster Infusion Pump (270 ml, 5 ml/hr), REF PS6504, Part No. 5001260. The pump is indicated for continuous and/or intermittent delivery of medication (such as local anesthetics or narcotics) to or around surgical wound sites and/or close proximity to nerves for preoperative, perioperative and postoperative regional anesthesia and pain management. Routes of administration may be intraoperative, perineural, percutaneous and epidural. The ON-Q Pump is also intended to significantly decrease narcotic use and pain when used to deliver local anesthetics to or around surgical wound sites or close proximity to nerves when compared with narcotic only pain management.
FDA Recall
Terminated
·I-Flow Corporation·Product code MEB·February 12, 2008
ON-Q pump with ONDEMAND bolus button, ON-Q C-bloc with ONDEMAND; ON-Q C-bloc with Select a Flow and ONDEMAND Model/Reference #: 7000180, 7000181, 7000182, 7000367, 7000397, CB003, CB005, CB006, P400X1-7+5/60, P400X2-14+5/30, P400X5+5/60, and PMB01. Part Numbers: 101347100, 101347300, 101347400, 101360200, 101368400, 101368600, 101368700, 102987000, 102987200, 102987300, 103161800, 103534300, 5001438, 5001470, 5001651, 5001780, 5001808, 5001809, 5001812, 7000180, 7000181, 7000182, & 7000367. Indicated for continuous and or intermittent delivery of medication to or around surgical wound sites and or close proximity to nerves.
FDA Recall
Terminated
·I-Flow Corporation·Product code MEB·May 8, 2012
I-Flow ON-Q Pain Relief System, T-Block Needle/Catheter Tray, Model #TBTB1089T The intended use of each component in the finished final trays is consistent with the intended use of the component stated in the respective 510(k) submission.
FDA Recall
Terminated
·I-Flow LLC·Product code BSO·June 1, 2012
I-Flow ON-Q Pain Relief System, T-Block Needle/Catheter Kit, Model #TB089T The intended use of each component in the finished final trays is consistent with the intended use of the component stated in the respective 510(k) submission.
FDA Recall
Terminated
·I-Flow LLC·Product code BSO·June 1, 2012
ON-Q PainBuster with OnDemand (270 ml, 2 ml/hr + 5 ml bolus /60 min refill), Model PMB01, I-Flow Corporation, Lake Forest, CA 92630 U.S.A.
FDA Recall
Terminated
·I-Flow Corporation·Product code MED·March 27, 2007
On-Q C-bloc 400 ml, 1-7 ml/hr Select-A-Flow + 5 ml/60 min ONDEMAND, REF CB005 indicated for continuous and/or intermittent delivery of medication (such as local anesthetics or narcotics) to or around surgical wound sites.
FDA Recall
Terminated
·I-Flow Corporation·Product code MEB·February 14, 2008
I-Flow ON-Q with Select-A-Flow Pumps, Intended for continuous and/or intermittent delivery of medication to and around surgical wound sites and/or close proximity to nerves for preoperative, perioperative and postoperative regional anesthesia and pain management. It is a controller that allows the user to regulate the amount of medication that is dispensed.
FDA Recall
Terminated
·I-Flow Corporation·Product code MEB·April 15, 2011
ON-Q Silver Dressing is a Antimicrobial wound dressing containing silver. It is individually wrapped in a foil pouch. Each pouch contains 1 single use 4" x 4.5" pad. There are 5 pouches per box. Ref: SD4X4.5; Part Number: IF-151023 and IF-151026. The product is labeled in parts: "***5 DRESSINGS***4 X 4.5 INCHES***REF SD4X4.5***PART NO. 5001826***ON-Q SilverDressing is a silver containing adhesive transparent polyurethane film for fixation and securement of devices to the skin as a primary contact sound dressing***MANUFACTURED BY ACRYMED***DISTRIBUTED BY I-FLOW***AcryMed, Inc Beaverton, OR 97008***". Intended for use in securing devices such as catheters to the skin. Also intended for use as a primary or secondary cover wound dressing on surgical incision sites.
FDA Recall
Terminated
·Acrymed Incorporated·Product code FRO·June 30, 2008
I-Flow ON-Q PainBuster (100 ml, 2 mI/hr) Pump, PM012, Lot #662449 and 662742
FDA Recall
Terminated
·I-Flow Corporation·Product code MEB·November 29, 2006
Tibiaxys Ankle Arthrodesis Plate Compression Guide, Model #159635, part # 159 635, Batch #: EAHZ, EAJ1, ELGV, ENQE & ENQH. Product Usage: The Compression guide is a re-usable instrument used in the implantation of the Tibiaxys product. The Tibiaxys system is intended for fixation of bone fractures or for bone reconstruction (arthrodesis, osteotomies, and fractures of ankle joint, distal tibia and fibula).
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code OYK·November 17, 2011
Aeroneb Go Micropump Nebulizer Featuring OnQ electronic micropump, RX, Manufactured by Medical Industries America Inc., Adel, IA. The product is sold individually or in master packs of 8 under the following model numbers (all using the same box label): Model 7000 - Consisting of the Aeroneb Go, battery controller, battery controller cable, 3 AA alkaline batteries, mask elbow, mouthpiece, carry bag, and user manual; Model 7030 - Consisting of the Aeroneb Go, AC wall adapter, mask elbow, mouthpiece, carry bag, and user manual; Model 7070 - Consisting of the Aeroneb Go, battery controller, battery controller cable, 3 AA alkaline batteries, AC wall adapter, mask elbow, mouthpiece, carry bag, and user manual; Model 7000-1 - Consisting of the Aeroneb Go, battery controller, battery controller cable, 3 AA alkaline batteries, European mask elbow, mouthpiece, carry bag, and user manual; Model 7030-1 - Consisting of the Aeroneb Go, AC wall adapter, European mask elbow, mouthpiece, carry bag, and user manual; Model 7070-1 - Consisting of the Aeroneb Go, battery controller, battery controller cable, 3 AA alkaline batteries, AC wall adapter, European mask elbow, mouthpiece, carry bag, and user manual. 7000LINCARE - Consisting of the Aeroneb Go, battery controller with a Lincare private label cover plate, battery controller cable, 3 AA alkaline batteries, mask elbow, mouthpiece, carry bag, and user manual; 7070LINCARE - Consisting of the Aeroneb Go, battery controller with the Lincare private label cover plate, battery controller cable, 3 AA alkaline batteries, AC wall adapter, mask elbow, mouthpiece, carry bag, and user manual.
FDA Recall
Terminated
·Medical Industries America Inc·Product code CAF·September 7, 2004
ConMed Eliminator Pyloric/Colonic PET Balloon Dilator; Outer Diameter (OD) size 18mm (54 Fr), length 4cm; product code/end item #000849 and #000859 (5 pack); Single Use, Non-Sterile; distributed by ConMed Endoscopic Technologies, Billerica, MA 01821.
FDA Recall
Terminated
·Conmed Endoscopic Technologies, Inc.·Product code KNQ·April 16, 2007
ConMed Eliminator Esophageal PET Balloon Dilator; Outer Diameter (OD) size 15mm (45 Fr), length 8cm; product code/end item #000344 and #000735 (5 pack); Single Use, Non-Sterile; distributed by ConMed Endoscopic Technologies, Billerica, MA 01821.
FDA Recall
Terminated
·Conmed Endoscopic Technologies, Inc.·Product code KNQ·April 16, 2007
ConMed Eliminator Esophageal PET Balloon Dilator; Outer Diameter (OD) size 12mm (36 Fr), length 8cm; product code/end item #000343 and #000443 (5 pack); Single Use, Non-Sterile; distributed by ConMed Endoscopic Technologies, Billerica, MA 01821.
FDA Recall
Terminated
·Conmed Endoscopic Technologies, Inc.·Product code KNQ·April 16, 2007
ConMed Eliminator Esophageal PET Balloon Dilator; Outer Diameter (OD) size 8mm (24 Fr), length 8cm; product code/end item #000341; Single Use, Non-Sterile; distributed by ConMed Endoscopic Technologies, Billerica, MA 01821.
FDA Recall
Terminated
·Conmed Endoscopic Technologies, Inc.·Product code KNQ·April 16, 2007
ConMed Eliminator Pyloric/Colonic PET Balloon Dilator; Outer Diameter (OD) size 12mm (36 Fr), length 4cm; product code/end item #000847 and #000857 (5 pack); Single Use, Non-Sterile; distributed by ConMed Endoscopic Technologies, Billerica, MA 01821.
FDA Recall
Terminated
·Conmed Endoscopic Technologies, Inc.·Product code KNQ·April 16, 2007
Quantum TTC Biliary Balloon Dilation Catheter, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105
FDA Recall
Terminated
·Cook Endoscopy·Product code KNQ·January 24, 2007