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) |
|---|---|---|---|
| Dec 5, 2024 | MEDLINE INDUSTRIES, LP - Northfield MEDLINE convenience kits labeled as:
1) ORTHO LAMINECTOMY-LF, REF CDS780112J;
2) NEURO CRANIOTOMY CDS #36-RF, REF CDS780119V;
3) BASIC BACK CDS, REF CDS780147N;
4) INSTRUMENTED BACK CDS, REF CDS7 Open, Classified |
OJH | None listed |
| Nov 25, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline Shoulder Repair Pack-LF, REF DYNJ82607, 2 kits/case, sterile. Open, Classified |
OJH | None listed |
| Nov 8, 2024 | MEDLINE INDUSTRIES, LP - Northfield ARTHROSCOPY Convenience kit used for surgical procedures, SKU SYNJ910004C Open, Classified |
OJH | None listed |
| Nov 8, 2024 | MEDLINE INDUSTRIES, LP - Northfield CARROLLTON HIP FX Convenience kit used for surgical procedures, SKU SYNJ910003A Open, Classified |
OJH | None listed |
| Oct 23, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline brand medical procedure convenience kits, labeled as:
1) NEW LONDON TOTAL KNEE CDS, REF CDS982519W;
2) HAND/FOOT CDS, REF CDS984003A;
3) SPECIAL PROCEDURE PACK, REF DYNJ32639C;
4) PK-ORTH Open, Classified |
OJH | None listed |
| Sep 24, 2024 | American Contract Systems, Inc. Hand Pack, AKHD97C; Medical convenience kit Open, Classified |
OJH | None listed |
| Sep 24, 2024 | American Contract Systems, Inc. Shoulder, SESH18I; Medical convenience kit Open, Classified |
OJH | None listed |
| Sep 24, 2024 | American Contract Systems, Inc. Open Shoulder, LWOS39L; Medical convenience kit Open, Classified |
OJH | None listed |
| Sep 24, 2024 | American Contract Systems, Inc. Arthroscopy Pack, MSKA45A; Medical convenience kit Open, Classified |
OJH | None listed |
| Sep 11, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline convenience kits containing semi-rigid suction liners labeled as follows:
a) LAMINECTOMY CDS, Pack Number CDS981510L;
b) ORTHO TRAUMA-LF, Pack Number DYNJ900720D;
c) ORTHO TRAUMA-LF, Pack Nu Open, Classified |
OJH | None listed |
| Sep 6, 2024 | MEDLINE INDUSTRIES, LP - Northfield ANESTHESIA TURNOVER KIT, Pack Number DYNJAA0377A Open, Classified |
OJH | None listed |
| Sep 6, 2024 | MEDLINE INDUSTRIES, LP - Northfield ANESTHESIA TURNOVER KIT, Pack Number DYNJAA0377 Open, Classified |
OJH | None listed |
| Sep 6, 2024 | MEDLINE INDUSTRIES, LP - Northfield KIT PEDI CRANI LAMI, Pack Number DYNJ907372A Open, Classified |
OJH | None listed |
| Sep 6, 2024 | MEDLINE INDUSTRIES, LP - Northfield CRANIOTOMY PACK, Pack Number DYNJ46552O Open, Classified |
OJH | None listed |
| Sep 6, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline Convenience kits, labeled as:
1) KNEE ARTHROSCOPY CDS-LF , Pack Number CDS983874F ;
2) HAND, Pack Number CDS984080F Open, Classified |
OJH | None listed |
| Sep 6, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline Convenience kits labeled as:
1) SPECIAL PROCEDURE PACK ARTERI , Pack Number 00-399024X ;
2) ARTHROSCOPY TRAY, Pack Number AM110A ;
3) HIP , Pack Number BM200A ;
4) SHOULDER ARTHROSCOPY, P Open, Classified |
OJH | None listed |
| Sep 6, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline Convenience kits, labeled as:
SPINAL BLOCK 22G QUINCKE 5S BU, Pack Number DYNJRA9026 Open, Classified |
OJH | None listed |
| Aug 28, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline procedural kits labeled as:
1) AFCH ANTERIOR SEGMENT PK, Pack Number DYNJ63330B ;
2) ANTERIOR HIP PACK , Pack Number DYNJ82317;
3) ARTHROGRAM, Pack Number DYNDH1446A ;
4) ARTHROGRAM TRAY, Open, Classified |
OJH | None listed |
| Aug 22, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline medical procedure kits labeled as follows:
a) ARTHROSCOPY, REF DYNJ909699;
b) BACK CDS, REF CDS984000C;
c) EXTREMITY, REF DYNJ900847A;
d) HAND-LF, REF DYNJ902619G;
e) HIP PINNING CDS, RE Open, Classified |
OJH | None listed |
| Aug 7, 2024 | American Contract Systems, Inc. American Contract Systems Extremity convenience kit, American Contract Systems Hand Pack convenience kit, and American Contract Systems Total Knee Pack convenience kit Open, Classified |
OJH | None listed |
| Jul 5, 2024 | American Contract Systems Inc KNEE ARTHROSCOPY PACK-Procedure Kit
Catalog Number: WEKA15B Open, Classified |
OJH | None listed |
| Jul 5, 2024 | American Contract Systems Inc HAND PACK-Procedure Kit
Catalog Number: WEHD16C Open, Classified |
OJH | None listed |
| Jul 5, 2024 | American Contract Systems Inc HAND PACK-Procedure Kit
Catalog Number: WEHD16B Open, Classified |
OJH | None listed |
| Jul 5, 2024 | American Contract Systems Inc ORIF HIP - IM RODDING FEMUR-Procedure Kit
Catalog Number: UTHP44S Open, Classified |
OJH | None listed |
| Jul 5, 2024 | American Contract Systems Inc CUSTOM KNEE - 206061-Procedure Kit
Catalog Number: UDKN68AG Open, Classified |
OJH | None listed |
| Jul 5, 2024 | American Contract Systems Inc CUSTOM KNEE - 206061-Procedure Kit
Catalog Number: UDKN68AE Open, Classified |
OJH | None listed |
| Jul 5, 2024 | American Contract Systems Inc ACL PACK - 206039-Procedure Kit
Catalog Number: UDAC66AA Open, Classified |
OJH | None listed |
| Jul 5, 2024 | American Contract Systems Inc TPK ANTERIOR HIP PACK 176483-Procedure Kit
Catalog Number: TPAH21E Open, Classified |
OJH | None listed |
| Jul 5, 2024 | American Contract Systems Inc ARTHROSCOPY PACK-Procedure Kit
Catalog Number: TNAR22V Open, Classified |
OJH | None listed |
| Jul 5, 2024 | American Contract Systems Inc ARTHROSCOPY PACK-Procedure Kit
Catalog Number: TNAR22U Open, Classified |
OJH | None listed |
| Jul 5, 2024 | American Contract Systems Inc TOTAL KNEE-Procedure Kit
Catalog Number: SMTK21C Open, Classified |
OJH | None listed |
| Jul 5, 2024 | American Contract Systems Inc KNEE ARTHROSCOPY-Procedure Kit
Catalog Number: SLAR14G Open, Classified |
OJH | None listed |
| Jul 5, 2024 | American Contract Systems Inc HAND DRAPING SJH-Procedure Kit
Catalog Number: SJHD67F Open, Classified |
OJH | None listed |
| Jul 5, 2024 | American Contract Systems Inc TOTAL KNEE-Procedure Kit
Catalog Number: SFTK54B Open, Classified |
OJH | None listed |
| Jul 5, 2024 | American Contract Systems Inc KNEE ARTHROSCOPY PACK-Procedure Kit
Catalog Number: SFAR60A Open, Classified |
OJH | None listed |
| Jul 5, 2024 | American Contract Systems Inc TOTAL KNEE - 297835 -Procedure Kit
Catalog Number: RGTK10L Open, Classified |
OJH | None listed |
| Jul 5, 2024 | American Contract Systems Inc TOTAL KNEE - 297835-Procedure Kit
Catalog Number: RGTK10K Open, Classified |
OJH | None listed |
| Jul 5, 2024 | American Contract Systems Inc HAND PACK 297829--Procedure Kit
Catalog Number: RGHN04I Open, Classified |
OJH | None listed |
| Jul 5, 2024 | American Contract Systems Inc TOTAL KNEE -Procedure Kit
Catalog Number: QPTK95B Open, Classified |
OJH | None listed |
| Jul 5, 2024 | American Contract Systems Inc TOTAL KNEE -Procedure Kit
Catalog Number: QPTK95A Open, Classified |
OJH | None listed |
| Jul 5, 2024 | American Contract Systems Inc KNEE ARTHROSCOPY-Procedure Kit
Catalog Number: QPKA35A Open, Classified |
OJH | None listed |
| Jul 5, 2024 | American Contract Systems Inc KNEE ARTHROSCOPY PACK
Catalog Number: MEKA12R Open, Classified |
OJH | None listed |
| Jul 5, 2024 | American Contract Systems Inc TOTAL KNEE, ST LUKES
Catalog Number: LMTK17AP Open, Classified |
OJH | None listed |
| Jul 5, 2024 | American Contract Systems Inc ACL, ST LUKES METHODIST 1CS
Catalog Number: LMAC10AA Open, Classified |
OJH | None listed |
| Jul 5, 2024 | American Contract Systems Inc UPPER EXTREMITY PK, STRL F G
Catalog Number: IHUE40AG Open, Classified |
OJH | None listed |
| Jul 5, 2024 | American Contract Systems Inc KNEE SCOPE Procedure tray
Catalog Number: COKN48L Open, Classified |
OJH | None listed |
| Jul 5, 2024 | American Contract Systems Inc HAND WRIST FOREARM-LF Procedure tray
Catalog Number: CCHD17B Open, Classified |
OJH | None listed |
| Jul 5, 2024 | American Contract Systems Inc FOOT ANKLE-LF Procedure tray
Catalog Number:CCFA51B Open, Classified |
OJH | None listed |
| Jul 5, 2024 | American Contract Systems Inc BPKN15C KNEE BASIN PACK BHS- Procedure tray
Catalog Number: BPKN15C Open, Classified |
OJH | None listed |
| Jul 5, 2024 | American Contract Systems Inc ARTHRO KNEE BEACHES PACK BHS- Procedure tray
Catalog Number: BPKB46B Open, Classified |
OJH | None listed |
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