Panels › Obstetrics/Gynecology › Product code OJF · Class 2
Hysterectomy Kit
Regulation 884.4530
0510(k)s in 12 months (0 all time)
15recalls in 12 months (30 all time)
0recalls that name a 510(k)
Top companies in OJF
| Company | 510(k)s | Recalls |
|---|---|---|
| Medline Industries, LP | 0 | 12 |
| MEDLINE INDUSTRIES, LP - Northfield | 0 | 9 |
| American Contract Systems Inc | 0 | 4 |
| Cardinal Health 200, LLC | 0 | 3 |
| Customed, Inc | 0 | 2 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 15, 2026 | Medline Industries, LP Convenience Kits containing CONMED AirSeal Access Ports
ADVANCE LAPAROSCOPIC
DYNJ911135A
CHN GYN ONCOLOGY
DYNJ906731M Open, Classified |
OJF | None listed |
| Sep 25, 2026 | Cardinal Health 200, LLC Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets:
1) KIT, LAVH , Catalog Number: PB63VHSTC Open, Classified |
OJF | None listed |
| Sep 25, 2026 | American Contract Systems Inc Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Catheter Trays
ABDOMINAL HYSTERECTOMY - 205989
Model No. MHAH55AM
LAVH-LAP COLON
Model No. SPLL54U
VAG HYST Open, Classified |
OJF | None listed |
| Sep 3, 2026 | Cardinal Health 200, LLC Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays:
1) PBCGLVBLI, Catalog Number: KIT, BLO LAVH ;
2) PB15HYFCY, Catalog Number: KIT, UMMC AB HYST II Open, Classified |
OJF | None listed |
| Aug 26, 2026 | Medline Industries, LP Medline convenience kits labeled as:
1) LAVH, Medline Kit SKU CDS982273U;
2) GYN ABDOMINAL CDS, Medline Kit SKU CDS982654L;
3) GYN LAP HYSTERECTOMY CDS, Medline Kit SKU CDS982662Q;
4) CMH VAG HYS Open, Classified |
OJF | None listed |
| Jun 17, 2026 | Medline Industries, LP MEDLINE Medical Procedure Kits labeled as CLOVIS HYSTEROSCOPY, CSC-N PELVISCOPY, D AND C PACK, D&C HYSTER PACK, FLWR GYN PACK, FS LAP TUBAL LIGATION, HILLSDALE D&C / HYSTEROSCOPY, LAVH NEW BRAUNFELS,T Open, Classified |
OJF | None listed |
| Jun 12, 2026 | Medline Industries, LP Medline convenience kits:
HYSTERECTOMY PACK-LF
DYNJ20485L Open, Classified |
OJF | None listed |
| Jun 12, 2026 | Medline Industries, LP Medline convenience kits:
WT LAVH PACK
DYNJ46609F Open, Classified |
OJF | None listed |
| May 7, 2026 | Medline Industries, LP Medline Convenience Kits:
1) HYSTEROSCOPY, Model Number: CDS984086I;
2) KIT GYN ONCOLOGY LAP, Model Number: DYKMBNDL91A;
3) VAGINAL HYSTERECTOMY PACK-LF, Model Number: DYNJ0373807J;
4) VAGINAL HYST Open, Classified |
OJF | None listed |
| Apr 30, 2026 | Medline Industries, LP Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows:
1. ROBOTIC HYSTERECTOMY, Medline Kit Number/SKU DYNJ904269B;
2. ROBOTIC HYSTERECTOMY, Medline Kit Number/SKU DY Open, Classified |
OJF | None listed |
| Apr 17, 2026 | Medline Industries, LP Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes
ENSEMBLE GYNECO SCOPIE-LF DYNJ53744B
LAVH GRH-LF DYNJ41792G Open, Classified |
OJF | None listed |
| Apr 17, 2026 | Medline Industries, LP Medline Kits:
1) HYSTEROSCOPY PACK, Model Number: DYNJ48399C;
2) SLING PACK, Model Number: DYNJ62849B Open, Classified |
OJF | None listed |
| Feb 17, 2026 | Medline Industries, LP Medline Convenience Kits:
1) HYSTEROSCOPY, Model Number: CDS984086I;
2) KIT GYN ONCOLOGY LAP, Model Number: DYKMBNDL91A;
3) VAGINAL HYSTERECTOMY PACK-LF, Model Number: DYNJ0373807J;
4) VAGINAL HYST Open, Classified |
OJF | None listed |
| Jan 14, 2026 | Medline Industries, LP Medline medical procedure convenience kits labeled as:
1) LAVH PROCEDURE, REF CDS980754T;
2) GYN LAP HYSTERECTOMY CDS, REF CDS982662Q;
3) DAVINCI HYSTERECTOMY CDS, REF CDS985344F;
4) LAVH, REF DY Open, Classified |
OJF | None listed |
| Nov 14, 2025 | Medline Industries, LP MEDLINE convenience kits labeled as:
1) GYN LAPAROTOMY HARPER PACK-LF, REF DYNJ0160684F;
2) MAJOR LITHOTOMY PACK-LF, REF DYNJ0425778O;
3) MINOR VAGINAL #76-RF, REF DYNJ27434R;
4) ABDOMINAL HYST P Open, Classified |
OJF | None listed |
| Aug 28, 2025 | American Contract Systems Inc AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as:
1) ROBOT HYST PACK, MODEL/ITEM NUMBER GRRB10E;
2) VAG HYST PACK, MODEL/ITEM NUMBER SPVH62P. Open, Classified |
OJF | None listed |
| Apr 17, 2025 | MEDLINE INDUSTRIES, LP - Northfield Medline Convenience kits used for various procedures:
1) PERI GYN PACK, Model Number: DYNJ80786;
2) D & C HYSTEROSCOPY PACK, Model Number: DYNJ21937J;
3) VAGINAL HYSTERECTOMY WRH-LF, Model Number: D Open, Classified |
OJF | None listed |
| Mar 25, 2025 | MEDLINE INDUSTRIES, LP - Northfield Medline procedure kits labeled as:
1) CSMC/ABDOMINAL HYST PACK-LF, Pack Number DYNJ0665086F;
2) MAJOR VAGINAL HARPER PACK-LF, Pack Number DYNJ0161768D;
3) ROBOT LAP TOTAL HYST, Pack Number DYNJ907 Open, Classified |
OJF | None listed |
| Feb 10, 2025 | Cardinal Health 200, LLC Cardinal Health Presource Kits:
1) KIT,ROBOTIC HYSTERECTOMY, Catalog Number:PB4FRHWFA;
2) KIT,ROBOTIC HYSTERECTOMY, Catalog Number:PB4FRHWFB
3) KIT,ROBOTIC HYSTERECTOMY, Catalog Number:PB4FRHWFC Open, Classified |
OJF | None listed |
| Dec 5, 2024 | MEDLINE INDUSTRIES, LP - Northfield MEDLINE convenience kits labeled as:
1) MAJOR LITHOTOMY CDS-LF, REF CDS760056G;
2) LAVH CDS, REF CDS983411J;
3) MAJOR VAGINAL, REF CDS983497L;
4) DAY SURG LARGE VAG CDS, REF CDS984995N;
5) GYN L Open, Classified |
OJF | None listed |
| Oct 23, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline brand medical procedure convenience kits, labeled as:
a) ABDOMINAL HYSTERECTOMY TEGH-LF, REF DYNJ46730;
b) HYSTEROSCOPY PACK, REF DYNJ49302A;
c) PERI GYN PACK, REF DYNJ57526A;
d) HYSTEROS Open, Classified |
OJF | None listed |
| Sep 6, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline Convenience kits labeled as:
1) OFFICE PACK FOR HYSTEROSCOPY, Pack Number C040100;
2) LAVH CDS, Pack Number CDS760049AD;
3) LAVH CDS, Pack Number CDS760049AF;
4) MAJOR LITHOTOMY CDS-LF, P Open, Classified |
OJF | None listed |
| Aug 28, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline procedural kits labeled as:
1) LEEP PACK, Pack Number DYNJ40348G;
2) TRAB BUCKLE DSC, Pack Number DYNJ63036B Open, Classified |
OJF | None listed |
| Jan 26, 2024 | American Contract Systems, Inc. Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as:
a) LavH, kit number BBLV21C;
b) LAP HYST 247540, kit number BFHY75U Open, Classified |
OJF | None listed |
| Oct 26, 2023 | American Contract Systems, Inc. LAVH, REF BBLV21C Open, Classified |
OJF | 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. CUSTOM GYN, Model Number: DYNJ63257C;
b. GYN EXP LAPAROTOMY, Model Number: DYNJ906 Open, Classified |
OJF | None listed |
| Jul 20, 2023 | MEDLINE INDUSTRIES, LP - Northfield Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:
a) VNUS TRAY, Model Number DYNJ44410G;
b) INTRAUTERINE TRNSFUSION -LF, Model Number DYNJ9048708I;
c) PERI NEURO Open, Classified |
OJF | None listed |
| Feb 6, 2023 | MEDLINE INDUSTRIES, LP - Northfield Sterile Procedural Trays, labeled as the following:
a. GYN ABD CDS
b. LAVH PROCEDURE
c. TAH CDS
d. CUH LITHOTOMY CDS
e. LAVH CDS
f. GROTH VAGINAL CDS
g. MAJOR LITHOTOMY
h. MAJOR VAGINAL HARPER PACK Open, Classified |
OJF | None listed |
| Dec 16, 2014 | Customed, Inc Total Hysterectomy, catalog #900-2415
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
OJF | None listed |
| Aug 29, 2014 | Customed, Inc TOTAL HYCTERECTOMY
(I) CANNULA 5MM XCEL SLEEVES LIF ( I ) TROCAR XCEL BLADELESS II MM
(I) TROCAR 5MM BLADELESS W/STAB SLEEVE LIF ( I) NEEDLE ULTRA VERES 120MM LIF
( I) TUBING INSUFFLAT SET Terminated |
OJF | None listed |
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