ClearanceBrief
Panels › Pathology › Product code FMH · Class 1

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)
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Top companies in FMH

DateFirm and productCodeLinked 510(k)
May 7, 2026Medline Industries, LP
Medline Convenience Kits: 1) DRAPE PACK-CHOICE, Model Number: DYNJ63118A
Open, Classified
FMHNone listed
Apr 30, 2026Medline Industries, LP
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: GENERAL KIT, Medline Kit Number/SKU DYNJ905664I
Open, Classified
FMHNone listed
Feb 17, 2026Medline Industries, LP
Medline Convenience Kits: 1) DRAPE PACK-CHOICE, Model Number: DYNJ63118A
Open, Classified
FMHNone listed
May 15, 2025Klinika 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
FMHNone listed
May 15, 2025Klinika 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
FMHNone listed
Sep 6, 2024MEDLINE 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
FMHNone listed
Mar 29, 2024MEDLINE 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
FMHNone listed
Dec 8, 2023Meridian 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
FMHK792710
Dec 8, 2023Meridian Bioscience Inc
Para-Pak Clean Vial-For the collection, transportation, preservation, and examination of stool specimens containing intestinal parasites Catalog Number: 900312
Open, Classified
FMHK792710
Aug 3, 2023MEDLINE 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
FMHNone listed
Feb 6, 2023MEDLINE INDUSTRIES, LP - Northfield
Sterile Procedural Trays, labeled as the following: LS MS PACK
Open, Classified
FMHNone listed
Apr 29, 2020Thermo 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
FMHNone listed
Dec 11, 2019Centurion 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
FMHNone listed
Jul 18, 2019Thermo Fisher Scientific (Monterrey)
Cardinal Health Brand 120mL/53mm sterile, individual peel pouch specimen container with orange cap (100/pk) Catalog number: CHB13905
Terminated
FMHNone listed
Jul 18, 2019Thermo Fisher Scientific (Monterrey)
Cardinal Health Brand 120mL/53mm sterile specimen container with orange cap, 75 pieces/pack, 4 packs/case Catalog number: CHB13904
Terminated
FMHNone listed
Mar 21, 2018Bard 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
FMHNone listed
Oct 14, 2016Covidien LLC
Covidien Precision Specimen Container- 4 oz (118 mL), Plastic Screw Top Cap, OR Packaged, Sterile Item Code: 17099
Terminated
FMHNone listed
Sep 3, 2015Customed, 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
FMHNone listed
Dec 16, 2014Customed, Inc
, Catalog # 900-913 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Terminated
FMHNone listed
Aug 29, 2014Customed, 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
FMHNone listed
Apr 4, 2013Becton 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
FMHNone listed

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