Container, Specimen, Sterile
Regulation 864.3250
0510(k)s in 12 months (23 all time)
3recalls in 12 months (21 all time)
2recalls that name a 510(k)
Top companies in FMH
| Company | 510(k)s | Recalls |
|---|---|---|
| MEDLINE INDUSTRIES, LP - Northfield | 0 | 4 |
| Sage Products, Inc. | 4 | 0 |
| Customed, Inc | 0 | 3 |
| Medline Industries, LP | 0 | 3 |
| Thermo Fisher Scientific (Monterrey) | 0 | 3 |
| C.R. Bard, Inc. | 2 | 0 |
| Klinika Mdical Gmb | 0 | 2 |
| Meridian Bioscience Inc | 0 | 2 |
| Sherwood Medical Co. | 2 | 0 |
| Abco Dealers, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 7, 2026 | Medline Industries, LP Medline Convenience Kits:
1) DRAPE PACK-CHOICE, Model Number: DYNJ63118A Open, Classified |
FMH | None listed |
| Apr 30, 2026 | Medline Industries, LP Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: GENERAL KIT, Medline Kit Number/SKU DYNJ905664I Open, Classified |
FMH | None listed |
| Feb 17, 2026 | Medline Industries, LP Medline Convenience Kits:
1) DRAPE PACK-CHOICE, Model Number: DYNJ63118A Open, Classified |
FMH | None listed |
| May 15, 2025 | Klinika Mdical Gmb KliniTray Platte Faxitron ,groB "R" sterile. Tissue resection margin examination board/large Model Number: 2001155-F
The medical device KliniTrayTM is a system for the precise monitoring, recording a Open, Classified |
FMH | None listed |
| May 15, 2025 | Klinika Mdical Gmb KliniTray. KlinioTray. Tissue resection margin examination board/small. Model Number: 2001105-F
The medical device KliniTrayTM is a system for the precise monitoring, recording and visualization of a Open, Classified |
FMH | None listed |
| Sep 6, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline Convenience kits labeled as:
1) KIT, MIDSTREAM, W/BZK/FUNNL,3O, Pack Number DYND30212;
2) PROCESSING KIT 3 PTE0000204 , Pack Number DYNJ65728A ;
3) 30ML KIT, Pack Number DYNJ82155A ;
4) D Open, Classified |
FMH | None listed |
| Mar 29, 2024 | MEDLINE INDUSTRIES, LP - Northfield Centurion Manual surgical kits labeled as:
a) 15ML SAMPLING TUBE WITH CAP, Product Code 15MLVLCP;
b) STERILE 9X12 RECLOSABLE BAG, Product Code MG912ST Open, Classified |
FMH | None listed |
| Dec 8, 2023 | Meridian Bioscience Inc Cardinal Health Clean Stool Transportation System-For the collection, transportation, preservation, and examination of stool specimens containing intestinal parasites
Catalog Number: CHB900312 Open, Classified |
FMH | K792710 |
| Dec 8, 2023 | Meridian Bioscience Inc Para-Pak Clean Vial-For the collection, transportation, preservation, and examination of stool specimens containing intestinal parasites
Catalog Number: 900312 Open, Classified |
FMH | K792710 |
| Aug 3, 2023 | MEDLINE INDUSTRIES, LP - Northfield Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following:
a. DBD-FLAP HARVEST PACK, Model Number: DYNJ58575C Open, Classified |
FMH | None listed |
| Feb 6, 2023 | MEDLINE INDUSTRIES, LP - Northfield Sterile Procedural Trays, labeled as the following: LS MS PACK Open, Classified |
FMH | None listed |
| Apr 29, 2020 | Thermo Fisher Scientific (Monterrey) Samco Bio-Tite Sterile Specimen Container, 120mL/53mm, Bio-Tite Blue Cap
Catalog Number: 07 0006
The specimen containers are used for temporary collection, transfer, and/or storage of body fluids an Terminated |
FMH | None listed |
| Dec 11, 2019 | Centurion Medical Products Corporation Centurion- Pathology Container
1150ST STERILE GRADUATED CONTAINER, 32 OZ.
17070 AI OR CARDIAC STERILE KIT
3703ST STERILE PATHOLOGY CONTAINER
3706ST STERILE CONTAINER 165 OZ. Terminated |
FMH | None listed |
| Jul 18, 2019 | Thermo Fisher Scientific (Monterrey) Cardinal Health Brand 120mL/53mm sterile, individual peel pouch specimen container with orange cap (100/pk)
Catalog number: CHB13905 Terminated |
FMH | None listed |
| Jul 18, 2019 | Thermo Fisher Scientific (Monterrey) Cardinal Health Brand 120mL/53mm sterile specimen container with orange cap, 75 pieces/pack, 4 packs/case
Catalog number: CHB13904 Terminated |
FMH | None listed |
| Mar 21, 2018 | Bard Medical Division Bard Midstream Urine Collector with Rigid Funnel and Iodophor Prep Pads. Product Packaging: Three (3) PVP-I prep pads are packed into each urine collection kit carton along with a pre-connected drain Terminated |
FMH | None listed |
| Oct 14, 2016 | Covidien LLC Covidien Precision Specimen Container- 4 oz (118 mL), Plastic Screw Top Cap, OR Packaged, Sterile
Item Code: 17099 Terminated |
FMH | None listed |
| Sep 3, 2015 | Customed, Inc CURATION KIT 10/CS
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate Terminated |
FMH | None listed |
| Dec 16, 2014 | Customed, Inc , Catalog # 900-913
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
FMH | None listed |
| Aug 29, 2014 | Customed, Inc CURATION KIT - CUSTOMED-
(10) GAUZE SPONGE 4" X 4" 16PL Y
(4) ABSORBENT TIP APPLICATOR
(4) PVP PREP SOLUTION 1 oz
(1) CONTAINER SPECIMEN 4oz WITH LID & LABEL
(2) EXAM GLOVES MEDIUM
(1) WRAPPER 24" X Terminated |
FMH | None listed |
| Apr 4, 2013 | Becton Dickinson & Company BD Vacutainer C&S Transfer Straw Kit C&S Preservative Plus Urine Tube. 4.0 ml, 13 X 75 mm STERILE REF 364953. Becton Dickinson & Company, Franklin Lakes, NJ USA,
The kit consists of a transfer st Terminated |
FMH | None listed |
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