Panels › Obstetrics/Gynecology › Product code OHM · Class 2
Cesarean Section Tray
Regulation 884.1720
0510(k)s in 12 months (0 all time)
13recalls in 12 months (74 all time)
3recalls that name a 510(k)
Top companies in OHM
| Company | 510(k)s | Recalls |
|---|---|---|
| Customed, Inc | 0 | 33 |
| Medline Industries Inc | 0 | 17 |
| MEDLINE INDUSTRIES, LP - Northfield | 0 | 12 |
| American Contract Systems | 0 | 6 |
| ROi CPS LLC | 0 | 3 |
| Cardinal Health 200, LLC | 0 | 2 |
| DeRoyal Industries Inc | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 3, 2026 | Cardinal Health 200, LLC Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays:
1) KIT, ROBOTIC HYST , Catalog Number: PB41RHRM3;
2) KIT, ROBOTIC HYST , Catalog Number: Open, Classified |
OHM | None listed |
| Aug 31, 2026 | Medline Industries, LP Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators
C-SECTION PREP
DYNJ32702B Open, Classified |
OHM | None listed |
| Aug 31, 2026 | Medline Industries, LP Medline Convenience Kits:
1) C-SECTION PREP, Model Number: DYNJ32702B Open, Classified |
OHM | None listed |
| Aug 26, 2026 | Medline Industries, LP Medline convenience kits labeled as:
1) C-SECTION, Medline Kit SKU DYNJ904612L;
2) C-SECTION, Medline Kit SKU DYNJ911755;
3) AHR C-SECTION KIT, Medline Kit SKU DYNJ912014. Open, Classified |
OHM | None listed |
| Jul 22, 2026 | Medline Industries, LP MEDLINE convenience kits labeled as:
1) C-SECTION, Medline SKU DYNJ910835;
2) C-SECTION, Medline SKU DYNJ910835A; medical convenience kits Open, Classified |
OHM | K213481 |
| Jun 25, 2026 | Medline Industries, LP Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes.
FTMC C-SECTION TRAY-LF
DYNJ54603B Open, Classified |
OHM | None listed |
| Jun 17, 2026 | Medline Industries, LP MEDLINE Medical Procedure Kits labeled as:
1) D AND C PACK, Medline Kit Number/SKU DYNJ53973C;
2) PK CUST CV A&B CABRINI CO, Medline Kit Number/SKU DYNJ60583C. Open, Classified |
OHM | None listed |
| Jun 12, 2026 | Medline Industries, LP Medline convenience kits:
C SECTION
CDS985505G
C SECTION PACK
DYNJ68260D
C-SECTION
DYNJ905094B
C-SECTION RECOVERY #2
CDS820091P Open, Classified |
OHM | None listed |
| Jun 12, 2026 | Medline Industries, LP Medline convenience kits:
C-SECTION KIT
DYNJ904305J
C-SECTION PACK
DYNJ69533C Open, Classified |
OHM | None listed |
| May 7, 2026 | Medline Industries, LP Medline Convenience Kits:
1) C-SECTION PACK, Model Number: CDS820080N;
2) C-SECTION CDS, Model Number: CDS983523G;
3) C-SECTION, Model Number: CDSCCR611O;
4) C-SECTION, Model Number: CDSCCR611P;
5 Open, Classified |
OHM | None listed |
| Feb 17, 2026 | Medline Industries, LP Medline Convenience Kits:
1) C-SECTION PACK, Model Number: CDS820080N;
2) C-SECTION CDS, Model Number: CDS983523G;
3) C-SECTION, Model Number: CDSCCR611O;
4) C-SECTION, Model Number: CDSCCR611P;
5 Open, Classified |
OHM | None listed |
| Jan 28, 2026 | Medline Industries, LP Medline medical procedure convenience kits labeled as:
1) C-SECTION PACK, Kit SKU DYNJ35494C;
2) SMJ C-SECTION PACK-LF, Kit SKU DYNJ38582O;
3) RR-L&D C-SECTION PACK-LF, Kit SKU DYNJ82084F. Open, Classified |
OHM | None listed |
| Nov 14, 2025 | Medline Industries, LP MEDLINE convenience kits labeled as:
1) C-SECTION OR 30 CDS, REF CDS820075W;
2) C-SECTION, REF CDS984261J;
3) C-SECTION CDS, REF CDS985282F;
4) C-SECTION PACK, REF DYNJ02577D;
5) C-SECTION PACK- Open, Classified |
OHM | None listed |
| Oct 16, 2025 | American Contract Systems Inc. Medical convenience kits
Item Number/Description
FHCP08Y C SECTION PK
HICS50I C-SECTION PACK
HSCB90B C-SECTION BASIN PACK Open, Classified |
OHM | None listed |
| Jul 21, 2025 | MEDLINE INDUSTRIES, LP - Northfield Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as:
C-SECTION PREP, REF DYNJ32702B Open, Classified |
OHM | None listed |
| Apr 17, 2025 | MEDLINE INDUSTRIES, LP - Northfield Medline Convenience kits used for various procedures:
1) ED CRASH C-SECTION TRAY, Model Number: MNS13635A;
2) C-SECTION PCH-LF, Model Number: DYNJ81281;
3) C-SECTION PACK-LF, Model Number: OBK387M; Open, Classified |
OHM | None listed |
| Mar 25, 2025 | MEDLINE INDUSTRIES, LP - Northfield Medline procedure kits labeled as:
1) C SECTION, Pack Number DYNJ57622;
2) C SECTION PACK, Pack Number DYNJ48483B;
3) C SECTION PACK, Pack Number DYNJ61573;
4) C SECTION PACK, Pack Number DYNJ668 Open, Classified |
OHM | None listed |
| Mar 18, 2025 | MEDLINE INDUSTRIES, LP - Northfield Medline procedure kits labeled as:
1) C SECTION, Pack Number DYNJ909098 Open, Classified |
OHM | None listed |
| Mar 14, 2025 | American Contract Systems Inc C-SECTION PPS
, Model No LLCI66M
LLCI66M-02
LLCI66M-03
LLCI66M-04 Open, Classified |
OHM | None listed |
| Mar 14, 2025 | American Contract Systems Inc C-SECTION PACK, Model Nos LLCS44F
LLCS44F-01 Open, Classified |
OHM | None listed |
| Dec 5, 2024 | MEDLINE INDUSTRIES, LP - Northfield MEDLINE convenience kits labeled as:
1) C-SECTION OR 30 CDS, REF CDS820075V;
2) C-SECTION OR 30 CDS, REF CDS820075W;
3) C-SECTION, REF CDS980774M;
4) C-SECTION KIT, REF CDS981322AB;
5) C-SECTION Open, Classified |
OHM | None listed |
| Sep 11, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline convenience kits containing semi-rigid suction liners labeled as follows: MERCY TIFFIN C-SECTION, Pack Number DYNJ909732 Open, Classified |
OHM | None listed |
| Sep 6, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline Convenience kits labeled as:
1) C-SECTION TRAY, Pack Number AM160B ;
2) C-SECTION TRAY, Pack Number AM160C ;
3) C-SECTION CDS , Pack Number CDS820031I ;
4) C-SECTION CDS , Pack Number CDS Open, Classified |
OHM | None listed |
| Aug 28, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline procedural kits labeled as:
1) SR C SECTION, Pack Number DYNJ908584;
2) SR C SECTION, Pack Number DYNJ908584A;
3) C SECTION, Pack Number DYNJ909098 Open, Classified |
OHM | None listed |
| Aug 22, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline medical procedure kits labeled as follows:
a) C-SECTION CDS, REF CDS983998C Open, Classified |
OHM | None listed |
| Feb 25, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline Kits, trays, and packs labeled as follows:
C-SECTION, REF DYNJ904653G Open, Classified |
OHM | None listed |
| Jan 26, 2024 | American Contract Systems, Inc. Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as:
a) C-SECTION PACK, kit number FDCS01AA;
b) C-SECTION PACK, kit number FDCS01AB;
c) C-SECTION STERILE PACK Open, Classified |
OHM | None listed |
| Oct 10, 2023 | Cardinal Health 200, LLC Procedure pack: Presource PBDS Cat. PLMHCSBHF, Hermann Hospital MHHS, Kit, C Section B MHHS, Sterile. Open, Classified |
OHM | None listed |
| Aug 3, 2023 | MEDLINE INDUSTRIES, LP - Northfield Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following:
a. C V MINOR PACK, Model Number: DYNJ64862A;
b. DBD-C SECTION ADM, Model Number: DYKL Open, Classified |
OHM | None listed |
| Jun 7, 2023 | DeRoyal Industries Inc Sterile custom surgical procedure packs
(1) 89-10529.04, CNRV OR C-SECTION PACK, New River Valley Medical Center; and
(2) 89-10567.05, OB-OR C-SECTION PACK, Carilion Roanoke Memorial Hospital. Open, Classified |
OHM | None listed |
| Apr 25, 2023 | ROi CPS LLC Sterile surgical convenience kit: regard Item Number 800706005, LD0091E - OH C-Section Pack. Open, Classified |
OHM | None listed |
| Feb 6, 2023 | MEDLINE INDUSTRIES, LP - Northfield Sterile Procedural Trays, labeled as the following:
a. C-SECTION OR 30 CDS
b. C-SECTION CDS
c. C-SECTION CDS
d. C-SECTION CDS
e. MAJOR ORTHO CDS-LF
f. C-SECTION CDS
g. C-SECTION CDS
h. C-SECTION PR Open, Classified |
OHM | None listed |
| Jul 19, 2022 | ROi CPS LLC Nonsterile convenience kit: regard Item #830014016, LD00199P - C Section Mother. Terminated |
OHM | None listed |
| Jun 16, 2022 | American Contract Systems, Inc. Various C-section packs Open, Classified |
OHM | None listed |
| Apr 26, 2022 | ROi CPS LLC Convenience kits containing regard IV Start Kits:
(1) regard Clinical Packaging Solutions, Item Number: 830014015, LD00199O - C Section Mother; and
(2) regard Clinical Packaging Solutions, Item Num Terminated |
OHM | None listed |
| Apr 13, 2020 | American Contract Systems Sterile Custom Packs to be used in surgical procedures. Terminated |
OHM | None listed |
| Apr 14, 2016 | Customed, Inc Catalog Number: 900998
CESAREAN SECTION SURGICAL PACK
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
OHM | None listed |
| Apr 14, 2016 | Customed, Inc Catalog Number: 900921A
C-SECTION SURGICAL PACK
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
OHM | None listed |
| Apr 14, 2016 | Customed, Inc Catalog Number: 900410
CESAREAN SECTION SURGICAL PACK
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
OHM | None listed |
| Apr 14, 2016 | Customed, Inc Catalog Number: 900403
CESAREAN SECTION SURGICAL PACK
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
OHM | None listed |
| Apr 14, 2016 | Customed, Inc Catalog Number: 9001294
PREMIUM CESAREAN PACK
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
OHM | K902273 |
| Sep 3, 2015 | Customed, Inc C-SECTION PK 2/CS
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate Terminated |
OHM | None listed |
| Sep 3, 2015 | Customed, Inc C-SECTION SURGICAL PACK 2/CS
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate Terminated |
OHM | None listed |
| Sep 3, 2015 | Customed, Inc CESAREAN PK 4/CS
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
. Terminated |
OHM | None listed |
| Sep 3, 2015 | Customed, Inc CESAREAN PACK 5/CS
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
. Terminated |
OHM | None listed |
| Sep 3, 2015 | Customed, Inc CESAREAN PACK 2/CS
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
. Terminated |
OHM | None listed |
| Sep 3, 2015 | Customed, Inc CESAREAN PACK 3/CS
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
. Terminated |
OHM | None listed |
| Sep 3, 2015 | Customed, Inc CESAREAN PACK 4/CS
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
. Terminated |
OHM | K902032 |
| Sep 3, 2015 | Customed, Inc CESAREAN PACK 3/CS
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
. Terminated |
OHM | None listed |
| Sep 3, 2015 | Customed, Inc PREMIUM CESAREAN PACK CUSTOMED 5/CS
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
. Terminated |
OHM | None listed |
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