32 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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Hays Ultrasound kit Item ID: H1000SE
FDA Enforcement
Class II
·Terminated·Exact Medical Manufacturing, Inc.·June 30, 2021
Hays Ultrasound kit Item ID: H1000SE
FDA Recall
Terminated
·Exact Medical Manufacturing, Inc.·Product code ITX·April 29, 2021
Hays Innovation Ultrasound Probe Cover Kit - Ultrasonic Transducer Cover Item ID: HS2000HL
FDA Enforcement
Class II
·Terminated·Exact Medical Manufacturing, Inc.·June 30, 2021
Hays Innovation Ultrasound Probe Cover Kit - Ultrasonic Transducer Cover Item ID: HS2000HL
FDA Recall
Terminated
·Exact Medical Manufacturing, Inc.·Product code ITX·April 29, 2021
PharmaCaribe PulmoSal 7% Sodium chloride, Inhalation Solution, 7% Sterile, Preservative -free, Non-pyrogenic, pH 7.4 For Inhalation Only Rx Product Usage: The contents of these vials are used in conjunction with a nebulizer for the induction of sputum production where sputum production is indicated.
FDA Enforcement
Class II
·Terminated·Pharmacaribe llc·February 17, 2016
Winged Infusion Set with 90 degree Huber Needle and Y Injection Site Distributed By: FloridaInfustion Services, Inc., Palm Harbor, FL 34683 Item # FIY-2210 Intended use: Intravascular Administration Set
FDA Recall
Terminated
·Churchill Medical Systems, Inc.·Product code FPA·November 16, 2010
Medline Strider Maxi 4 Scooter; a four wheeled battery operated scooter; manufactured by KYMCO, Kaohsiung, Taiwan for Medline Industries, Inc., One Medline Place, Mundelein, IL 60060 USA; model MDS807650 - red and MDS807650B - blue
FDA Recall
Terminated
·Medline Industries Inc·Product code INI·July 20, 2006
Medline Strider Maxi 3 Scooter; a three wheeled battery operated scooter; manufactured by KYMCO, Kaohsiung, Taiwan for Medline Industries, Inc., One Medline Place, Mundelein, IL 60060 USA; model MDS807600 - red and MDS807600B - blue
FDA Recall
Terminated
·Medline Industries Inc·Product code INI·July 20, 2006
Intesys Clinical Suite (ICS) G2 92810 Smart Disclosure. The Smart Disclosure product collects patient waveforms, alarms, vital signs and 12-lead reports. A 24-hour waveform acquisition is standard, with an upgrade option to 72 hours. The product provides basic trends in both tabular and graphical format, along with a retrospective ECG analysis. The analysis may be defined by patient, and the data may be presented in multiple formats, including a rhythm, a histogram, and a summary view. Standard reports are available from Smart Disclosure, including saved events, disclosure, trends histogram and summary.
FDA Recall
Terminated
·Spacelabs Healthcare, Incorporated·Product code DQK·October 17, 2008
Medical Device Exchange Insufflation Needle; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number C2201; EXP (repackager), Medline (OEM) Insufflator, laparoscopic
FDA Recall
Terminated
·EXP Pharmaceutical Services Corp·Product code HIF·February 11, 2015
Pnemosure Insufflators, model numbers 620-040-600 and 620-040-610, manufactured by Stryker Endoscopy, San Jose, CA.
FDA Recall
Terminated
·Stryker Endoscopy·Product code HIF·December 29, 2008
Aquilex Fluid Control System component: Bag deflector, REF AQL-100CBS Product Usage: Distends uterus with fluid during diagnostic and operative hysteroscopies.
FDA Recall
Terminated
·WOM World of Medicine AG Salzufer 8 Berlin Germany·Product code HIG·August 14, 2019
Stryker Heated Tube Set with Real-Time Pressure Sensing (RTP), REF 0620-040-690, an accessory to the PNEUMO SURE High Flow Insufflator, Disposable, Rx, Sterile.
FDA Recall
Terminated
·Stryker Corporation·Product code HIF·March 7, 2019
Stryker High Flow Tube Set with Real-Time Pressure Sensing (RTP), REF 0620-040-680, an accessory to the PNEUMO SURE High Flow Insufflator, Disposable, Rx, Sterile.
FDA Recall
Terminated
·Stryker Corporation·Product code HIF·March 7, 2019
Stryker High Flow II Tube Set, REF 0620-040-660, an accessory to the PNEUMO SURE High Flow Insufflator, Disposable, Rx, Sterile.
FDA Recall
Terminated
·Stryker Corporation·Product code HIF·March 7, 2019
Storz Equipment, Fluid Management Stand, for Fluid Management Systems, Product Number 26601EQ-KT
FDA Recall
Terminated
·Karl Storz Endoscopy America Inc 600 Corporate Pointe·Product code HIG·August 17, 2007
McKesson Medi-Pak Vaginal Speculum, 10/bag Reorder No. 11-8309 Used to expose interior of the vagina to facilitate visualization during gynecological and obstetrical procedures
FDA Recall
Terminated
·CooperSurgical, Inc.·Product code HIB·April 13, 2015
Insufflator, laparoscopic The ConMed GS2000, Smith & Nephew 500, Novadaq 50L and Nebulae I insufflators are devices that provide CO2 gas distention of surgical cavities for diagnostic and/or operative endoscopy. The insufflator has multiple operating modes which can be used for the following procedures: General Laparoscopic, Pediatric Laparoscopic, Bariatric Laparoscopic and Minimally Invasive Vessel Harvesting procedures
FDA Recall
Terminated
·Northgate Technologies, Inc.·Product code HIF·November 21, 2016
ConMed 50L abdominal insufflator, Catalog Number 72-00258-0 / GS2000 - Product Usage: The device will maintain an expanded cavity (pneumoperitoneum) to allow the insertion of a variety of surgical instruments through the abdominal wall for visual examination of the interior or for surgery (laparoscopic surgery).
FDA Recall
Terminated
·Northgate Technologies, Inc.·Product code HIF·January 15, 2021
Tube Set for TEM - Product Usage: Transanal Endoscopic Microsurgery (TEM) combination system and the instrument set for the TEM procedure are designed to provide access to the rectal cavity and accessible part of the lower sigmoid colon using a stereo and/or monocular endoscope under gas tight conditions for the excision of polyps and/or the removal of tumors that have been previously staged.
FDA Recall
Terminated
·Richard Wolf GmbH Pforzheimer Str. 32 Knittlingen Germany·Product code HIF·June 5, 2020