Company
Custom Healthcare Systems, Inc.
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
33recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 20, 2019 | Custom Healthcare Systems, Inc. Custom Healthcare Systems, Inc. Inpatient Dialysis Kit PAK-19244. Single use.
Dialysis kit Terminated |
LRO | None listed |
| Aug 13, 2018 | Custom Healthcare Systems, Inc. CHS Custom Convenience Kit- LITTLE SNIPPER CIRCUMCISION TRAY
Part Number: YMCIR-400 Terminated |
LRO | None listed |
| Aug 13, 2018 | Custom Healthcare Systems, Inc. CHS Custom Convenience Kit-FENESTRATED DRAPE 40 X 62P
Part Number: 1222-2112 Terminated |
LRO | None listed |
| Aug 13, 2018 | Custom Healthcare Systems, Inc. CHS Custom Convenience
(1) 1231-150L GOWN, RAGLAN, LG, NONREINF
(2) 1231-150XL GOWN, RAGLAN, XL, NONREINF
(3) 1231-140XL GOWN, SPECIALTY XL, XLONG Terminated |
LRO | None listed |
| Aug 13, 2018 | Custom Healthcare Systems, Inc. CHS Custom Convenience Kit:
1231-110XL SURGICAL GOWN, NRF W. HAND TOWEL
1231-080XL GOWN, SURGICAL XXL
1231-150XL GOWN, SURGICAL XXL Terminated |
LRO | None listed |
| Aug 13, 2018 | Custom Healthcare Systems, Inc. CHS Custom Convenience Kit-SURGICAL GOWN, LARGE SET IN SLEEVES
Product Number:1231-050L Terminated |
LRO | None listed |
| Aug 13, 2018 | Custom Healthcare Systems, Inc. CHS Custom Convenience Kit-TUBING W. CONNECTOR
Product Number:UNC-10884 Terminated |
LRO | None listed |
| Aug 13, 2018 | Custom Healthcare Systems, Inc. CHS Custom Convenience Kit- UNC-VIR TRAY
Product Number:UNC-17914 Terminated |
LRO | None listed |
| Aug 13, 2018 | Custom Healthcare Systems, Inc. CHS Custom Convenience Kit-BONE MARROW TRAY
Product Number:B9-4000 Terminated |
LRO | None listed |
| Aug 13, 2018 | Custom Healthcare Systems, Inc. CHS Custom Convenience Kit- PENROSE DRAIN (.75" X 18")
Product Number:D8-9425B Terminated |
LRO | None listed |
| Aug 13, 2018 | Custom Healthcare Systems, Inc. CHS Custom Convenience Kit-SUTURE REMOVAL KIT (W.ADSON SERR)Product Number:UNC-9481B Terminated |
LRO | None listed |
| Aug 13, 2018 | Custom Healthcare Systems, Inc. CHS Custom Convenience Kit-FORMULA CAP (10'S
Product Number: UNC-9538 Terminated |
LRO | None listed |
| Aug 13, 2018 | Custom Healthcare Systems, Inc. CHS Custom Convenience Kit- COBAN, LF (1"X5 YDS)
Product Number:D5-14591 Terminated |
LRO | None listed |
| Aug 13, 2018 | Custom Healthcare Systems, Inc. CHS Custom Convenience Kit-ROCHESTER PEAN, CURVED (8")
Product Number:D36-16669 Terminated |
LRO | None listed |
| Aug 13, 2018 | Custom Healthcare Systems, Inc. CHS Custom Convenience Kit-CONNECTOR PACK
Product Number:D36-7520 Terminated |
LRO | None listed |
| Aug 13, 2018 | Custom Healthcare Systems, Inc. CHS Custom Convenience Kit-SUTURE REMOVAL KIT #1
Product Number: -ZZ-0664 Terminated |
LRO | None listed |
| Aug 13, 2018 | Custom Healthcare Systems, Inc. CHS Custom Convenience Kit-TOENAIL REMOVAL TRAY
Product Number: (1) ZZ-0956; (2) ZZ-0685 Terminated |
LRO | None listed |
| Aug 13, 2018 | Custom Healthcare Systems, Inc. CHS Custom Convenience Kit-WEBSTER NEEDLE HOLDER
Product Number:01-375C Terminated |
LRO | None listed |
| Aug 13, 2018 | Custom Healthcare Systems, Inc. CHS Custom Convenience Kit-LP NEEDLE, 22G X 1
Product Number:NC401000 Terminated |
LRO | None listed |
| Aug 13, 2018 | Custom Healthcare Systems, Inc. CHS Custom Convenience Kit-GENERAL UTILITY TRAY
Product Number:S1528-02 Terminated |
LRO | None listed |
| Aug 13, 2018 | Custom Healthcare Systems, Inc. (1)CHS Custom Convenience Kit-VAGINAL SPECULUM (SMALL)
Product Number:D36-16267
(2) CHS Custom Convenience KitVAGINAL SPECULUM (LARGE)
Product Code: D36-16269 Terminated |
LRO | None listed |
| Aug 13, 2018 | Custom Healthcare Systems, Inc. CHS Custom Convenience Kit-MOSQUITO FORCEPS 5 STR
Product Number:B9-18914 Terminated |
LRO | None listed |
| Aug 13, 2018 | Custom Healthcare Systems, Inc. CHS Custom Convenience Kit-TOOTHBRUSH, 46 TUFT Product Number:R1635 Terminated |
LRO | None listed |
| Aug 13, 2018 | Custom Healthcare Systems, Inc. CHS Custom Convenience Kit-PAD, COTTON SINGLE
Product Number:R1178 Terminated |
LRO | None listed |
| Aug 13, 2018 | Custom Healthcare Systems, Inc. CHS Custom Convenience Kit-SPECIALIST CAST PADDING 3" X 4 YDS)
Product Number:D4-324SCP Terminated |
LRO | None listed |
| Aug 13, 2018 | Custom Healthcare Systems, Inc. CHS Custom Convenience Kit-FOERSTER SPONGE FORCEPS, SERR, ST (9.5 )
Product Number:-D36-14623 Terminated |
LRO | None listed |
| Aug 13, 2018 | Custom Healthcare Systems, Inc. CHS Custom Convenience Kit-COTTON TIP APPLICATORS, 10'S (6")
Product Number:R1112B Terminated |
LRO | None listed |
| Aug 13, 2018 | Custom Healthcare Systems, Inc. CHS Custom Convenience Kit-
(1) DT SCATPAD, DBL. TAPE, 12.5 X 16.5
Product Number: SEPA 402
(2) SCATPAD, 11 X 34
Product Number: SPA502 Terminated |
LRO | None listed |
| Aug 13, 2018 | Custom Healthcare Systems, Inc. CHS Custom Convenience Kit-INJECTION TRAY
Product Number: B9-17201 Terminated |
LRO | None listed |
| Aug 13, 2018 | Custom Healthcare Systems, Inc. CHS Custom Convenience Kit-DR. NANDA CLOSING TRAY(CONMED HYFRECATOR SHARP)
Product Number: B9-15934B Terminated |
LRO | None listed |
| Jul 17, 2015 | Custom Healthcare Systems, Inc. Safety PICC Insertion Tray with Chloraprep OneStep - Model #5026CL-9 - 12 pr case. Packaged for Physician use only. Terminated |
GCB | None listed |
| Feb 7, 2013 | Custom Healthcare Systems, Inc. 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 phys Terminated |
FCH | None listed |
| Feb 7, 2013 | Custom Healthcare Systems, Inc. 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 Terminated |
FCH | None listed |