36 results
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66ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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Custom Healthcare Systems, Inc. Inpatient Dialysis Kit PAK-19244. Single use. Dialysis kit
FDA Enforcement
Class II
·Terminated·Custom Healthcare Systems, Inc.·February 5, 2020
Custom Breast Biopsy Tray, Catalog # B 9-16261, packaged in bags, 1 tray/bag, 20 bags/case. Product Usage: A sterile medical device containing multiple components utilized by physician to perform a breast biopsy.
FDA Enforcement
Class II
·Terminated·Custom Healthcare Systems, Inc.·February 13, 2013
CHS Custom Convenience Kit-DR. NANDA CLOSING TRAY(CONMED HYFRECATOR SHARP) Product Number: B9-15934B
FDA Enforcement
Class II
·Terminated·Custom Healthcare Systems, Inc.·October 31, 2018
Safety PICC Insertion Tray with Chloraprep OneStep - Model #5026CL-9 - 12 pr case. Packaged for Physician use only.
FDA Enforcement
Class II
·Terminated·Custom Healthcare Systems, Inc.·July 29, 2015
Custom Breast Biopsy Tray w/Sodium Chloride, Catalog # B9-15263A, packaged in bags, 1 tray/bag, 20 bags/case. Product Usage: A sterile medical device containing multiple components utilized by physician to perform a breast biopsy.
FDA Enforcement
Class II
·Terminated·Custom Healthcare Systems, Inc.·February 13, 2013
CHS Custom Convenience (1) 1231-150L GOWN, RAGLAN, LG, NONREINF (2) 1231-150XL GOWN, RAGLAN, XL, NONREINF (3) 1231-140XL GOWN, SPECIALTY XL, XLONG
FDA Enforcement
Class II
·Terminated·Custom Healthcare Systems, Inc.·October 31, 2018
CHS Custom Convenience Kit-GENERAL UTILITY TRAY Product Number:S1528-02
FDA Enforcement
Class II
·Terminated·Custom Healthcare Systems, Inc.·October 31, 2018
CHS Custom Convenience Kit-MOSQUITO FORCEPS 5 STR Product Number:B9-18914
FDA Enforcement
Class II
·Terminated·Custom Healthcare Systems, Inc.·October 31, 2018
CHS Custom Convenience Kit-INJECTION TRAY Product Number: B9-17201
FDA Enforcement
Class II
·Terminated·Custom Healthcare Systems, Inc.·October 31, 2018
CHS Custom Convenience Kit- UNC-VIR TRAY Product Number:UNC-17914
FDA Enforcement
Class II
·Terminated·Custom Healthcare Systems, Inc.·October 31, 2018
CHS Custom Convenience Kit: 1231-110XL SURGICAL GOWN, NRF W. HAND TOWEL 1231-080XL GOWN, SURGICAL XXL 1231-150XL GOWN, SURGICAL XXL
FDA Enforcement
Class II
·Terminated·Custom Healthcare Systems, Inc.·October 31, 2018
CHS Custom Convenience Kit-TUBING W. CONNECTOR Product Number:UNC-10884
FDA Enforcement
Class II
·Terminated·Custom Healthcare Systems, Inc.·October 31, 2018
CHS Custom Convenience Kit-FOERSTER SPONGE FORCEPS, SERR, ST (9.5 ) Product Number:-D36-14623
FDA Enforcement
Class II
·Terminated·Custom Healthcare Systems, Inc.·October 31, 2018
CHS Custom Convenience Kit-WEBSTER NEEDLE HOLDER Product Number:01-375C
FDA Enforcement
Class II
·Terminated·Custom Healthcare Systems, Inc.·October 31, 2018
CHS Custom Convenience Kit- LITTLE SNIPPER CIRCUMCISION TRAY Part Number: YMCIR-400
FDA Enforcement
Class II
·Terminated·Custom Healthcare Systems, Inc.·October 31, 2018
CHS Custom Convenience Kit-FENESTRATED DRAPE 40 X 62P Part Number: 1222-2112
FDA Enforcement
Class II
·Terminated·Custom Healthcare Systems, Inc.·October 31, 2018
CHS Custom Convenience Kit-SUTURE REMOVAL KIT (W.ADSON SERR)Product Number:UNC-9481B
FDA Enforcement
Class II
·Terminated·Custom Healthcare Systems, Inc.·October 31, 2018
CHS Custom Convenience Kit-SPECIALIST¿ CAST PADDING 3" X 4 YDS) Product Number:D4-324SCP
FDA Enforcement
Class II
·Terminated·Custom Healthcare Systems, Inc.·October 31, 2018
CHS Custom Convenience Kit-LP NEEDLE, 22G X 1 Product Number:NC401000
FDA Enforcement
Class II
·Terminated·Custom Healthcare Systems, Inc.·October 31, 2018
CHS Custom Convenience Kit-PAD, COTTON SINGLE Product Number:R1178
FDA Enforcement
Class II
·Terminated·Custom Healthcare Systems, Inc.·October 31, 2018