48 results
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12ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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ARCHITECT CA 19-9XR Reagent Kit; ARCHITECT CA 19-9 Reagent Kit, list 291-20 (4 x 100 tests), 2K91-25 and 2K91-27 (1 x 100 tests); Product Usage: The ARCHITECT CA 19-9XR assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of 1116-NS-19-9 reactive determinants in human serum or plasma on the ARCHITECT i System. The ARCHITECT CA-19-9XR assay is to be used as an aid in the management of pancreatic cancer patients in conjunction with other clinical methods.
FDA Recall
Terminated
·Abbott Laboratories·Product code NIG·May 30, 2012
ARCHITECT CA 19-9XR Reagent Kit; ARCHITECT CA 19-9 Reagent Kit, list 291-20 (4 x 100 tests), 2K91-25 and 2K91-27 (1 x 100 tests); Product Usage: The ARCHITECT CA 19-9XR assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of 1116-NS-19-9 reactive determinants in human serum or plasma on the ARCHITECT i System. The ARCHITECT CA-19-9XR assay is to be used as an aid in the management of pancreatic cancer patients in conjunction with other clinical methods.
FDA Enforcement
Class II
·Terminated·Abbott Laboratories·July 4, 2012
Alaris Pump Module, Model 8100, serviced/repaired by Step-Har Medical with an impacted bezel repair part
FDA Enforcement
Class I
·Terminated·STEP-HAR MEDICAL LLC·May 19, 2021
Walcott Rx Products, Surgical Division, Corneal Marking Pad, REF RX40490, Sterile. For use in ophthalmic surgery.
FDA Recall
Terminated
·Aspen Surgical Products, Inc.·Product code HMR·December 23, 2010
Aspen Surgical, Corneal Marking Pad, Gentian Violet Ink, REF 40490, Rx only, Sterile. For use in ophthalmic surgery.
FDA Recall
Terminated
·Aspen Surgical Products, Inc.·Product code HMR·December 23, 2010
Maximum Pelvic Trainer (MPT)
FDA Recall
Terminated
·Ralston Group·Product code HIR·July 12, 2019
Oasis Corneal Marking Pad, REF 0441, Rx only, Sterile. For use in ophthalmic surgery.
FDA Recall
Terminated
·Aspen Surgical Products, Inc.·Product code HMR·December 23, 2010
Eagle Labs Corneal Marking Pad, Gentian Violet, REF 63-001, Sterile. For use in ophthalmic surgery.
FDA Recall
Terminated
·Aspen Surgical Products, Inc.·Product code HMR·December 23, 2010
Viscot Medical, LLC., Vismark Gentian Violet Marking Pad, Rx Only, Sterile, REF GV1200S. For use in ophthalmic surgery.
FDA Recall
Terminated
·Aspen Surgical Products, Inc.·Product code HMR·December 23, 2010
CYNACON OcuSOFT LASIK Marker Pads, REF 750-093, Rx Only, Sterile. For use in ophthalmic surgery.
FDA Recall
Terminated
·Aspen Surgical Products, Inc.·Product code HMR·December 23, 2010
Alaris Pump Module, Model 8100, serviced/repaired by Step-Har Medical with an impacted bezel repair part
FDA Recall
Terminated
·STEP-HAR MEDICAL LLC·Product code FRN·February 26, 2021
Capnostream20 (US) M W/PRINTER TO MASIMO, Part Number CS08751
FDA Recall
Terminated
·Oridion Medical 1987 Ltd. Har Hotzvim Industrial·Product code DQA·July 31, 2018
CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-02
FDA Recall
Terminated
·Oridion Medical 1987 Ltd. Har Hotzvim Industrial·Product code DQA·July 31, 2018
Capnostream20 (US) M W/PRINTER REFURBISHED, Part Number CS78659
FDA Recall
Terminated
·Oridion Medical 1987 Ltd. Har Hotzvim Industrial·Product code DQA·July 31, 2018
Capnostream20 (US) N REFURBISHED, Part Number CS78651
FDA Recall
Terminated
·Oridion Medical 1987 Ltd. Har Hotzvim Industrial·Product code DQA·July 31, 2018
Capnostream20 (INTL) M, CS08654
FDA Recall
Terminated
·Oridion Medical 1987 Ltd. Har Hotzvim Industrial·Product code DQA·July 31, 2018
Capnostream20 (US) N W/PRINTER REFURBISHED, Part Number CS78657
FDA Recall
Terminated
·Oridion Medical 1987 Ltd. Har Hotzvim Industrial·Product code DQA·July 31, 2018
CAPNOSTREAM 20P (COV-INTL) N W/PRINTER ROHS, CS051COV
FDA Recall
Terminated
·Oridion Medical 1987 Ltd. Har Hotzvim Industrial·Product code DQA·July 31, 2018
Capnostream20 M ADULT ICU (CPM), CS08654RA
FDA Recall
Terminated
·Oridion Medical 1987 Ltd. Har Hotzvim Industrial·Product code DQA·July 31, 2018
CAPNOSTREAM 20 (INTL) N, Part Number CS08652
FDA Recall
Terminated
·Oridion Medical 1987 Ltd. Har Hotzvim Industrial·Product code DQA·July 31, 2018