95 results
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11ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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CDLCAM, First-Pass Radionuclide Angiography Camera System, Model 70-500101, with operating Software Version B1A, marketed by CDL Medical Tech.
FDA Recall
Terminated
·GVI Technology Partners·Product code IYX·January 16, 2004
BVI Custom Eyes Ophthalmic Procedure Kits with the component -Devon Light Glove Part Number: 584569 Ophthalmic surgical kits
FDA Recall
Terminated
·Beaver-Visitec International Inc.·Product code FSY·May 1, 2015
BVI Custom Eyes Ophthalmic Procedure Kits with the component -Devon Light Glove Part Number: 584676 Ophthalmic surgical kits
FDA Recall
Terminated
·Beaver-Visitec International Inc.·Product code FSY·May 1, 2015
BVI Custom Eyes Ophthalmic Procedure Kits with the component -Devon Light Glove Part Number: 584649 Ophthalmic surgical kits
FDA Recall
Terminated
·Beaver-Visitec International Inc.·Product code FSY·May 1, 2015
BVI Custom Eyes Ophthalmic Procedure Kits with the component -Devon Light Glove Part Number: 584671 Ophthalmic surgical kits
FDA Recall
Terminated
·Beaver-Visitec International Inc.·Product code FSY·May 1, 2015
BVI Custom Eyes Ophthalmic Procedure Kits with the component -Devon Light Glove Part Number: 584648 Ophthalmic surgical kits
FDA Recall
Terminated
·Beaver-Visitec International Inc.·Product code FSY·May 1, 2015
11-VI Incorporated Laser diode component Non-certified laser diode component used in laser sights for firearms
FDA Recall
Terminated
·Ii Vi Incorporated·Product code N/A·December 13, 2017
The BladderScan BVI 9400 is a portable ultrasound instrument that provides a noninvasive measurement of urinary bladder volume. The device consists of an ultrasound probe that scans the patient's bladder, and a battery operated console that provides measurement related information. The BVI 9400 measures ultrasonic reflections on multiple planes inside the body and produces a three dimensional image. Based on the image, the BVI 9400 calculates and displays bladder volume.
FDA Recall
Terminated
·Verathon, Inc.·Product code IYO·May 18, 2009
BVI 9600 Bladder Volume Instrument, Aorta Scan Mode The BladderScan BVI 9600 with AortaScan Mode is a user-selectable, dual-function ultrasound device that projects ultrasound energy either into the lower abdomen to obtain an image of the bladder for measuring bladder volume, or into the mid-abdomen to obtain an image of the abdominal aorta for aortic diameter measurements.
FDA Recall
Terminated
·Verathon, Inc.·Product code IYO·August 23, 2010
BladderScan BVI 9600, Model Numbers: 0270-0451, 0270-0452, 0270-0754, and U270-0451. AortaScan AMI 9700, Model Numbers: 0270-0636, 0270-0639, and U270-0636.
FDA Recall
Terminated
·Verathon, Inc.·Product code IYO·November 30, 2015
Safety Sideport Knife 1.0mm 45, REF 378210 Product Usage: Indicated to make stab incisions during ophthalmic surgery
FDA Recall
Terminated
·Beaver Visitec·Product code EMF·May 14, 2018
Slit Knife 2.6mm 45degree Bevel Up, Model Number 373726. for use in ophthalmic surgery.
FDA Recall
Terminated
·Beaver Visitec·Product code HNN·June 18, 2018
BVI Visitec Soft Tip Cannula, 0.8MM .50 x 33mm (25G x 1.3 in). The BVI Soft Tip Cannula is intended to irrigate and/or aspirate ophthalmic solutions and liquids in or out of the eye, and remove materials where appropriate (e.g. retinal, subretinal procedures).
FDA Enforcement
Class II
·Terminated·Beaver Visitec·April 3, 2019
11-VI Incorporated Laser diode component Non-certified laser diode component used in laser sights for firearms
FDA Enforcement
Class II
·Terminated·Ii - Vi Incorporated·June 13, 2018
Visitec Anterior Chamber Cannula, .40x22mm (27Gx7/8in) REF 585006 Cannulae are intended to irrigate and or aspirate ophthalmic solutions and liquids in or out of the eye, and remove materials where appropriate. These products are used in all sections of the eye. This cannula is a general use cannula mainly designed for the precise maintenance of optimum anterior chamber depth
FDA Recall
Terminated
·Beaver-Visitec International Inc.·Product code HMX·May 6, 2014
BVI Visitec Soft Tip Cannula, 0.8MM .50 x 33mm (25G x 1.3 in). The BVI Soft Tip Cannula is intended to irrigate and/or aspirate ophthalmic solutions and liquids in or out of the eye, and remove materials where appropriate (e.g. retinal, subretinal procedures).
FDA Recall
Terminated
·Beaver Visitec·Product code HMX·November 30, 2018
BioRad BioPlex 2200 Software, for BioPlex 2200 Instrument, an automated immunodiagnostic analyzer, Bio-Rad Laboratories, Inc., Hercules, CA 94547
FDA Recall
Terminated
·Bio-Rad Laboratories Inc·Product code NVI·November 13, 2007
SKINFUSE Resuce Calming Complex Kit containing: SKINFUSE LIFT HG - Product Usage: The SKINFUSE Rescue Calming Complex is intend to be used to soothe and calm skin (cosmetic). The SKINFUSE LIFT HG is a hydrogel wound dressing to protect against abrasion and friction during the microneedling procedure.
FDA Recall
Terminated
·Bellus Medical·Product code QAI·January 18, 2019
AVI Sterile Impad Rigid Sole Foot Cover, Right Foot Product Code:6066
FDA Recall
Terminated
·Product code JOW·August 11, 2010
AVI Sterile Impad Rigid Sole Foot Cover, Left Foot Product Code:6067
FDA Recall
Terminated
·Product code JOW·August 11, 2010