2,050 results
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24ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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propper brand cal-mark(R), Micro-Hematocrit Calibrated Capillary Tubes, CALIBRATED-HEPARINIZED, reorder no. 043021, 6 Vials, 100 Tubes per Vial, Length 75 mm., 0.55 mm. I.D., 1.40-1.75mm. O.D. Calibrated 60mm from end for use in direct reading centrifuges. Fill to the 60mm mark with blood and seal opposite end by flame or with sealing compound. If centrifuged on a direct reading centrifuge, read percent hematocrit directly from scale on the centrifuge. Otherwise, read in normal manner as a percent ratio of packed cells with 60mm of sample as 100%. Firm on label: propper manufacturing co., inc., long island city, n.y. 11101.
FDA Recall
Terminated
·Propper Mfg Co Inc·Product code G-IO·August 9, 2002
Capillary (end) caps, accessory for use with blood gas analyzers included in Radiometer''s CLINITUBES kits. The end caps are packaged in bags. These bags are placed in the capillary tube kit which also contains: capillary tubes, end caps, mixing wires, and a magnet. Each kit may contain 1 or 5 bags depending on the kit model. Each bag contains: 110 Green caps per bag and 160 Red caps per bag.
FDA Recall
Terminated
·Radiometer America Inc·Product code GIO·March 22, 2006
Separation Technology ClearCRIT Capillary Tubes 75mm/0.5mm ID. Catalog number 270-107. Separation Technology Inc, 1096 Rainer Drive, Altamonte Springs, FL 32714. Heparin-treated capillary tube used for spun hematocrit packed cell volume (PCV) determination.
FDA Recall
Terminated
·Drummond Scientific Co·Product code GIO·August 1, 2008
Iris Sample Processing SafeCrit 40mm Tubes. Catalog number 59-000869-002 H. Iris Sample Processing, 60 Glacier Drive, Westwood, MA 02090. Heparin-treated capillary tube used for spun hematocrit packed cell volume (PCV) determination.
FDA Recall
Terminated
·Drummond Scientific Co·Product code GIO·August 1, 2008
Iris Sample Processing SafeCrit 75mm Tubes. Iris Sample Processing, 60 Glacier Drive, Westwood, MA 02090. Heparin-treated capillary tube used for spun hematocrit packed cell volume (PCV) determination.
FDA Recall
Terminated
·Drummond Scientific Co·Product code GIO·August 1, 2008
Capillary (end) caps, accessory for use with blood gas analyzers included in Radiometer''s CLINITUBES kits. The end caps are packaged in bags. These bags are placed in the capillary tube kit which also contains: capillary tubes, end caps, mixing wires, and a magnet. Each kit may contain 1 or 5 bags depending on the kit model. Each bag contains: 110
FDA Recall
Terminated
·Radiometer America Inc·Product code GIO·March 22, 2006
Separation Technology ClearCRIT Capillary Tubes 75mm/1.1mm ID. Catalog number 270-106. Separation Technology Inc, 1096 Rainer Drive, Altamonte Springs, FL 32714. Heparin-treated capillary tube used for spun hematocrit packed cell volume (PCV) determination.
FDA Recall
Terminated
·Drummond Scientific Co·Product code GIO·August 1, 2008
safeCLINITUBES Blood Sampler;REF 942-969;D957P-70-45x1
FDA Recall
Terminated
·Radiometer Medical ApS Akandevej 21 Bronshoj Denmark·Product code GIO·March 17, 2020
SafeClinitubes, REF 942-892, D957P-70-100x1, contained in kits containing 250 SafeClinitubes, insert, mixing wires and end caps. Capillary samplers for drawing small amounts of blood for blood gas analysis.
FDA Recall
Terminated
·Radiometer America Inc·Product code GIO·June 22, 2006
safeCLINITUBES Blood Sampler;REF 942-892;D957P-70-100x1
FDA Recall
Terminated
·Radiometer Medical ApS Akandevej 21 Bronshoj Denmark·Product code GIO·March 17, 2020
safeCLINITUBES Blood Sampler;REF 942-898;D957P-70-70x1
FDA Recall
Terminated
·Radiometer Medical ApS Akandevej 21 Bronshoj Denmark·Product code GIO·March 17, 2020
Vitrex Blood Gas Capillary Tubes, MC0024, REF 189301, 250 pcs, 1,45 x 1,85 x 125 mm app. 200l, Heparinized: 6 IU Na & 9 IU Li/100 l,
FDA Recall
Terminated
·Opti Medical Systems Inc·Product code GIO·May 8, 2008
SafeClinitubes, Capillary caps (purple), 905-787. The defective capillary caps may be included in capillary tube kits as follows: Clinitubes Kits: 942-890 (D941P-240-85x1), Lot Code: R0048; Clinitubes Kits: 942-892 (D957P-70-100x1), Lot Codes: R0045 through R0050; Clinitubes Kits: 942-893 (D957P-70-125x1), Lot Codes: R0058 through R0063; Clinitubes Kits: 942-898 (D957P-70-70x1), Lot Code: R0019. Each of the kits listed above contains one (1) bag of Capillary Caps, 905-787.
FDA Recall
Terminated
·Radiometer America Inc·Product code GIO·June 29, 2006
Brand Name: Dexcom G6 CGM App for iOS Software Number: SW11677 Software Version: Version 1.4.0 up to corrected Version 1.4.4 GUDID Registered GTIN: 00386270000804
FDA Recall
Terminated
·Dexcom Inc·Product code QBJ·November 19, 2019
Version 1.2.0 of Accu-Chek Connect Diabetes Management App (iOS) released on July 11, 2016
FDA Recall
Terminated
·Roche Diabetes Care, Inc.·Product code NDC·September 14, 2016
C3 Wave App, v. 2.0.5
FDA Recall
Terminated
·Medical Components, Inc dba MedComp·Product code LJS·October 1, 2018
reSET Mobile App, iOS and Android, provides cognitive behavioral therapy, as part of substance abuse treatment.
FDA Enforcement
Class II
·Terminated·Pear Therapeutics, Inc.·June 30, 2021
reSET-O Mobile App, iOS and Android, provides cognitive behavioral therapy, as part of substance abuse treatment.
FDA Enforcement
Class II
·Terminated·Pear Therapeutics, Inc.·June 30, 2021
MY01 Continuous Compartmental Pressure Monitor, Reference Number MY01-0001
FDA Recall
Terminated
·Product code LXC·June 28, 2021
The Guardian Connect App CSS7200 iOS - Product Usage: intended for use by patients with a compatible consumer mobile device.
FDA Recall
Terminated
·Medtronic Inc.·Product code MDS·July 15, 2020