Panels › General, Plastic Surgery › Product code LRO · Class 2
General Surgery Tray
Regulation 878.4370
0510(k)s in 12 months (110 all time)
103recalls in 12 months (1,084 all time)
141recalls that name a 510(k)
Top companies in LRO
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 4, 2020 | Cardinal Health 200, LLC Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020 Terminated |
LRO | None listed |
| Feb 3, 2020 | Cardinal Health 200, LLC Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020. Additional kits produced through February 19, 2020 Terminated |
LRO | None listed |
| Jan 3, 2020 | ROi CPS LLC Custom procedure packs, containing Clearlink Continu-Flo, labeled as follows:
a) regard LD00200L-VAG DELIVERY MOTHER - JOPLIN, Item Number 830015012
b) regard GS00310C - Max Barrier Central Line Trpl Terminated |
LRO | None listed |
| Dec 20, 2019 | Custom Healthcare Systems, Inc. Custom Healthcare Systems, Inc. Inpatient Dialysis Kit PAK-19244. Single use.
Dialysis kit Terminated |
LRO | None listed |
| Dec 11, 2019 | Centurion Medical Products Corporation Centurion-
PT225 PAIN MANAGEMENT TRAY Terminated |
LRO | None listed |
| Oct 24, 2019 | Centurion Medical Products Corporation Centurion Medical Products UNIVERSAL LINE FULL BODY DRAPE KIT - REG
Code: DT11955 Terminated |
LRO | None listed |
| Jul 15, 2019 | Centurion Medical Products Corporation Kit, Port Access
Product Code: DYNDC1582A Terminated |
LRO | None listed |
| Jun 18, 2019 | DeRoyal Industries Inc DeRoyal THE RESOURCE GROUP, CRANI PACK, REF 89-9211.07
custom surgical pack Terminated |
LRO | K842648 |
| Jan 21, 2019 | Stryker GmbH Instrument Tray, Basic T2 Femur Long
Catalog #: 1806-9900
Product Usage: Knee Arthroplasty Terminated |
LRO | None listed |
| Nov 16, 2018 | Cardinal Health Inc. Presource Kit Total Joint Pack containing a double-wrapped basin component.
Product Usage: This kit is used on patients undergoing joint replacement knee or hip. 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 |
| Jun 26, 2018 | Encore Medical, Lp Instrument trays used to store AltiVate Small Shell Trials (FA S ALTIVATE RSP HUM TRLS SM).
Metal container with lid used to organize and transport instrumentation to be used in orthopedic surgery. Terminated |
LRO | None listed |
| Jan 22, 2018 | DeRoyal Industries Inc Custom sterile surgical packs labeled as follows:
GEO-MED CABG PACK PGYBK A & B, REF 89-5985.07, STERILE EO
Use: Shoulder Arthroscopy Terminated |
LRO | K842648 |
| Dec 19, 2017 | DeRoyal Industries Inc DeRoyal Sterile Custom kits containing Covidien-Dover(TM) Irrigation Tray with Piston Syringe Containing Medline Aplicare Povidone Iodine Prep Pads, labeled as follows:
(a) Shoulder Arthroscopy Pack 8 Terminated |
LRO | K842648 |
| Oct 24, 2017 | Windstone Medical Packaging, Inc. AMS, ALIGNED MEDICAL SOLUTIONS, T&A Pack, AMS6357, STERILE EO. Terminated |
LRO | None listed |
| Oct 16, 2017 | DeRoyal Industries Inc DeRoyal Sterile Custom kits containing Medline Aplicare Povidone Iodine Prep Pads:
a) Incision and Drainage Tray, REF 47-763.04
b) Incision and Drainage Tray, REF 47-763.06
c) Incision and Drainage Tr Terminated |
LRO | K842648 |
| Sep 25, 2017 | Resource Optimization & Innovation Llc Regard Custom Surgical Pack
Packs contain surgical instruments and accessories intended for use during a surgical procedure. Open, Classified |
LRO | None listed |
| Aug 25, 2017 | Alcon Research, LTD. Alcon Custom Pak Terminated |
LRO | K880961 |
| Aug 22, 2017 | Custom Assemblies Inc Various custom surgical kits manufactured for CMS, CUSTOM MEDICAL SPECIALTIES, INC.:
(a) CMS-4153-R2 MPM Biopsy TRAY
(b) CMS-5832-R1 Custom Safety Mammo Biopsy Tray
(c) CMS-4108 Multipurpose Safety Terminated |
LRO | None listed |
| Aug 14, 2017 | Cardinal Health 200, LLC Presource(R) Kits (custom surgical/procedural kits):
The standard and custom kits are packed with all of the specific disposable class I, II, and II implantable, life-supporting, or life-sustaining d Terminated |
LRO | None listed |
| Jul 3, 2017 | Avid Medical, Inc. AVID Medical QA Pack AV10654-10 Terminated |
LRO | None listed |
| Jun 22, 2017 | Avid Medical, Inc. AVID TruCustom UPPER EXTREMITY convenience kits, Item Code: LGHM050-03 and LGHM050-04 Terminated |
LRO | None listed |
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