Panels › General, Plastic Surgery › Product code OJH · Class 1
Orthopedic Tray
Regulation 878.4800
0510(k)s in 12 months (0 all time)
35recalls in 12 months (239 all time)
3recalls that name a 510(k)
Top companies in OJH
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 5, 2024 | American Contract Systems Inc ARTHO KNEE BAPTIST SOUTH PACK Procedure tray
Catalog Number: BPKA49B Open, Classified |
OJH | None listed |
| Jul 5, 2024 | American Contract Systems Inc ARTHROSCOPY SUP JOI PACK Procedure tray
Catalog Number: BPAS17C Open, Classified |
OJH | None listed |
| Jul 5, 2024 | American Contract Systems Inc ARTHROSCOPY WOLFSON PACK BHS Procedure tray
Catalog Number: BPAR65A Open, Classified |
OJH | None listed |
| Jul 5, 2024 | American Contract Systems Inc TOTAL KNEE - 247546 Procedure tray
Catalog Number: BFTK01Z Open, Classified |
OJH | None listed |
| Jul 5, 2024 | American Contract Systems Inc TOTAL KNEE - 247546 - Procedure tray
Catalog Number: BFTK01AA Open, Classified |
OJH | None listed |
| Jul 5, 2024 | American Contract Systems Inc LOWER EXTREMITY - 247542- Procedure tray
Catalog Number: BFLE56X Open, Classified |
OJH | None listed |
| Jul 5, 2024 | American Contract Systems Inc MAJOR KNEE - 302497- Procedure tray
Catalog Number: ASKN23B Open, Classified |
OJH | None listed |
| Jul 5, 2024 | American Contract Systems Inc TOTAL KNEE - 302497- Procedure tray
Catalog Number: ANTK12AF Open, Classified |
OJH | None listed |
| Jul 5, 2024 | American Contract Systems Inc AHAR50K STANDARD ARTHROSCOPY PACK - 291852. Procedure tray
Catalog Number: AHAR50K Open, Classified |
OJH | None listed |
| May 29, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline medical procedure kits, labeled as follows:
a) PARACERVICAL PUD TRAY, REF DYNDH1832;
b) AHS PARACERVICAL/PUDENDAL KIT, REF DYNJRA2210;
c) PARACERVICAL/PUDENDAL BLK KIT, REF DYNJRA9046;
d) Open, Classified |
OJH | None listed |
| Feb 25, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline Kits, trays, and packs labeled as follows:
a) ANTERIOR PACK, REF DYNJ64814A;
b) ARTHROGRAM TRAY, REF DYNDH1629;
c) CVL INSERTION KIT-LF, REF DYNJ48587A;
d) EXTREMITY CDS, REF CDS983313I; Open, Classified |
OJH | None listed |
| Jan 26, 2024 | American Contract Systems, Inc. Custom procedural convenience kits and trays, Othopedic use, labeled as:
a) HIP FRACTURE, kit number AHHF15C;
b) HIP FRACTURE, kit number AHHF15D;
c) Hand Pack, kit number BBHP10E;
d) Lower Extre Open, Classified |
OJH | None listed |
| Oct 10, 2023 | Cardinal Health 200, LLC Procedure packs:
(1) Presource PBDS Cat. PN33BPCR2, Kit, Back, Sterile;
(2) Presource PBDS Cat. POCGANA11, Kit, ARN Anterior Hip, Sterile;
(3) Presource PBDS Cat. PODKHAKAB, Kit, Hip Arthroscopy, Ste Open, Classified |
OJH | None listed |
| Aug 10, 2023 | MEDLINE INDUSTRIES, LP - Northfield Total Hip Kit, REF DYNJ903275S; surgical convenience kit Open, Classified |
OJH | 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. ANGIOGRAPHY PACK, Model Number: DYNJ65963A;
b. ARTHOGRAM TRAY, Model Number: PAIN1 Open, Classified |
OJH | None listed |
| Jul 20, 2023 | MEDLINE INDUSTRIES, LP - Northfield Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:
a) TOTAL JOINT, Model Number CDS985555S;
b) TOTAL KNEE, Model Number CDS985566Q;
c) MAJOR ORTHO-LF, Model Number Open, Classified |
OJH | None listed |
| Jul 20, 2023 | MEDLINE INDUSTRIES, LP - Northfield Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:
a) CRANIOTOMY CDS-1, Model Number CDS982889I;
b) JOINT INJECTION TRAY, Model Number DYNDH1722;
c) LOWER EXTREM Open, Classified |
OJH | None listed |
| Jun 15, 2023 | American Contract Systems, Inc. Total Knee Pack, REF CETJ130, medical convenience kits Open, Classified |
OJH | None listed |
| May 26, 2023 | MEDLINE INDUSTRIES, LP - Northfield Procedure packs:
(1) Medline Sterile Arthroscopy Pack, REF: DYNJ64242B;
(2) Medline Sterile Shoulder Pack, REF: DYNJ64250A; and
(3) Medline Sterile Upper Extremity Pack, REF: DYNJ64253B. Open, Classified |
OJH | None listed |
| Apr 25, 2023 | ROi CPS LLC Sterile surgical convenience kits:
1. regard Item Number: 880473001, OR01105A - Total Shoulder/Hip;
2. regard Item Number: 880426004, OR01033D - Total Hip;
3. regard Item Number: 880427003, O Open, Classified |
OJH | None listed |
| Feb 23, 2023 | MEDLINE INDUSTRIES, LP - Northfield (1) Medline Sterile Hand Pack, Item DYNJ63380A, 3 kits per case, contains BD Chloraprep Hi-Lite Orange, 26 mL Applicator, Vendor PN: 930815NS; and
(2) Medline Sterile Hand Pack, Item DYNJ63380C, 3 ki Open, Classified |
OJH | None listed |
| Feb 10, 2023 | MEDLINE INDUSTRIES, LP - Northfield Surgical convenience kits labeled as:
a) MEDLINE HAND PACK, Reorder Number DYNJ67850;
b) MEDLINE SHOULDER SUSPENSION II-LF, Reorder Number DYNJSHOULDER2;
c) MEDLINE TRAY BONE MARRO ASC LTX SAFE, Open, Classified |
OJH | None listed |
| Feb 10, 2023 | MEDLINE INDUSTRIES, LP - Northfield Surgical convenience kits labeled as:
MEDLINE SHOULDER SUSPENSION I-LF, Reorder Number DYNJSHOULDER Open, Classified |
OJH | None listed |
| Feb 6, 2023 | MEDLINE INDUSTRIES, LP - Northfield Sterile Procedural Trays, labeled as the following:
a. SPINAL
b. SPINE CDS
c. TOTAL ORTHO CDS
d. TOTAL KNEE CDS
e. CDS HIP-LF
f. KNEE TOTAL PACK-LF
g. EXTREMITY CDS
h. SHOULDER ARTHRO CDS
i. GLENNO Open, Classified |
OJH | None listed |
| Jan 27, 2023 | MEDLINE INDUSTRIES, LP - Northfield Non-sterile procedural trays labeled as TOTAL KNEE KIT, 1 per case Open, Classified |
OJH | None listed |
| Jan 27, 2023 | MEDLINE INDUSTRIES, LP - Northfield Non-sterile procedural trays labeled as THEDA CLARK TOTAL KNEE CDS, 1 per case Open, Classified |
OJH | None listed |
| Jan 27, 2023 | MEDLINE INDUSTRIES, LP - Northfield Non-sterile procedural trays labeled as ORTHO TRAUMA, 1 per case Open, Classified |
OJH | None listed |
| Jan 27, 2023 | MEDLINE INDUSTRIES, LP - Northfield Non-sterile procedural trays labeled as CRANI, 2 per case Open, Classified |
OJH | None listed |
| Dec 14, 2022 | Stradis Medical, LLC dba Stradis Healthcare HENRY SCHEIN, EXTREMITY PACK, Item No.570-2946 Open, Classified |
OJH | None listed |
| Dec 14, 2022 | Stradis Medical, LLC dba Stradis Healthcare HENRY SCHEIN, Knee Pack, Item No.570-2908, Open, Classified |
OJH | None listed |
| Dec 14, 2022 | Stradis Medical, LLC dba Stradis Healthcare HENRY SCHEIN, MAJOR EXTREMITY PACK, Item No.570-2783, Open, Classified |
OJH | None listed |
| Nov 23, 2022 | ROi CPS LLC regard SHOULDER ARTHROSCOPY, OR01103A, Item Number 880471001; ortho surgery convenience kit Terminated |
OJH | None listed |
| Nov 23, 2022 | ROi CPS LLC regard SPINE, OR01100A, Item Number 880468001; ortho surgery convenience kit Terminated |
OJH | None listed |
| Nov 23, 2022 | ROi CPS LLC regard HIP ARTHROSCOPY, OR01092B, Item Number 880462002; ortho surgery convenience kit Terminated |
OJH | None listed |
| Nov 23, 2022 | ROi CPS LLC regard LATERAL SHOULDER, OR01044C, Item Number 880435003; ortho surgery convenience kit Terminated |
OJH | None listed |
| Nov 23, 2022 | ROi CPS LLC regard SHOULDER, GS00828G, Item Number 880367007; ortho surgery convenience kit Terminated |
OJH | None listed |
| Nov 23, 2022 | ROi CPS LLC regard SHOULDER PACK, GS00125V, Item Number 880120022; ortho surgery convenience kit Terminated |
OJH | None listed |
| Nov 23, 2022 | ROi CPS LLC regard SHOULDER PK, GS00125U, Item Number 880120021; ortho surgery convenience kit Terminated |
OJH | None listed |
| Nov 23, 2022 | ROi CPS LLC regard FOOT PACK - MERCY SPRINGFIELD , OR00123Z, Item Number 880118026; ortho surgery convenience kit Terminated |
OJH | None listed |
| Nov 23, 2022 | ROi CPS LLC regard SHOULDER ARTHROSCOPY, OR00049Q, Item Number 880044017; ortho surgery convenience kit Terminated |
OJH | None listed |
| Nov 23, 2022 | ROi CPS LLC regard TOTAL HIP ARTHROPLASTY A&B, OR00032W, Item Number 880028023; ortho surgery convenience kit Terminated |
OJH | None listed |
| Nov 23, 2022 | ROi CPS LLC regard HAND PACK, OR00594K, Item Number 800243011; ortho surgery convenience kit Terminated |
OJH | None listed |
| Nov 23, 2022 | ROi CPS LLC regard SHOULDER W BCH CHAIR, OR00356F, Item Number 800203006; ortho surgery convenience kit Terminated |
OJH | None listed |
| Nov 23, 2022 | ROi CPS LLC regard SPINE PACK, NU00260H, Item Number 800022008; ortho surgery convenience kit Terminated |
OJH | None listed |
| Nov 23, 2022 | ROi CPS LLC regard KYPHOPLASTY, OR01101, Item Number 880469; orthopedic surgery convenience kit Terminated |
OJH | None listed |
| Nov 23, 2022 | ROi CPS LLC regard TOTAL JOINT, OR00446F, Item Number 880291; orthopedic surgery convenience kit Terminated |
OJH | None listed |
| Nov 23, 2022 | ROi CPS LLC regard FOOT PACK, OR00123Y, Item Number 880118; orthopedic surgery convenience kit Terminated |
OJH | None listed |
| Jun 16, 2022 | American Contract Systems, Inc. Various convenience packs Open, Classified |
OJH | None listed |
| Jun 6, 2022 | MEDLINE INDUSTRIES, LP - SPT MEDLINE INDUSTRIES, LP - SPT: Open, Classified |
OJH | None listed |
| Mar 22, 2022 | American Contract Systems, Inc. 1) ACS Arthroscopy Kit
2) ACS Knee Kit
3) ACS Hand Pack Open, Classified |
OJH | None listed |
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