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) |
|---|---|---|---|
| Oct 15, 2026 | Medline Industries, LP Medline surgical convenience kits labeled as:
1) SPINAL CDS, Medline Product Number/SKU CDS940087AM;
2) CUSTOM CRANI, Medline Product Number/SKU DYNJ907697C;
3) FEM POP PACK-LF, Medline Product Nu Open, Classified |
OJH | None listed |
| Sep 24, 2026 | Medline Industries, LP Medline Convenience Kits:
1) ANTERIOR SPINE PACK, Catalog Number: DYNJT10197;
2) CRANIOTOMY #IMF 56646-LF, Catalog Number: DYNJVB91001;
3) CRANIOTOMY PACK-LF, Catalog Number: DYNJ0369348O;
4) SLUH Open, Classified |
OJH | None listed |
| Sep 3, 2026 | Cardinal Health 200, LLC Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays:
1) KIT, CHONY ORTHO MAJOR SPINE , Catalog Number: POV2SCCPP;
2) KIT,ORTHOPLASTIC MICROVASCULAR, Catalog Number: Open, Classified |
OJH | None listed |
| Aug 31, 2026 | Medline Industries, LP Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators
ORTHO ASPIRATION KIT
DYKM1636A Open, Classified |
OJH | None listed |
| Aug 31, 2026 | Medline Industries, LP Medline Convenience Kits:
1) ORTHO ASPIRATION KIT, Model Number: DYKM1636A;
2) SHOULD BLOCK KIT, Model Number: DYKM1881A;
3) TRIMA KIT, Model Number: DYNDB3077C Open, Classified |
OJH | None listed |
| Aug 28, 2026 | AVID Medical, Inc. Halyard medical convenience kits labeled as:
1) A-P PACK - 205936, Model/Item Number (kit) ANAP22-01;
2) POSTERIOR PACK - 205960, Model/Item Number (kit) ANPP15-01;
3) ANEURYSM PACK, Model/Item Nu Open, Classified |
OJH | None listed |
| Aug 26, 2026 | Medline Industries, LP Medline convenience kits labeled as:
1) LAMI FUSION, Medline Kit SKU CDS982035Y;
2) NON MB MJR NEURO CRANI SM PK, Medline Kit SKU DYNJT6104;
3) CRANIOTOMY, Medline Kit SKU DYNJ903471I;
4) KIT CRA Open, Classified |
OJH | None listed |
| Aug 21, 2026 | Medline Industries, LP Medline medical convenience kits, labeled as:
1) LAMINECTOMY PACK, Medline Kit SKU DYNJT6548;
2) ORTHO SPINE PACK, Medline Kit SKU DYNJ44504G;
3) NEURO SPINE PACK, Medline Kit SKU DYNJ45419F;
4) Open, Classified |
OJH | None listed |
| Aug 20, 2026 | American Contract Systems Inc American Contract Systems medical procedure kits and trays labeled as:
1) ANTERIOR CERVICAL PACK - 205988, Model Item Number MHAC65AH;
2) SPINE PACK - 206013, Model Item Number MHSP99AF. Open, Classified |
OJH | None listed |
| Aug 13, 2026 | Cardinal Health 200, LLC Cardinal Health Presource Kits:
1) KIT, MER NEURO BACK , Catalog Number: PN33NBMYD;
2) KIT,CHP BASIC NEURO , Catalog Number: PN36NBCH4;
3) KIT,CHP BASIC NEURO , Catalog Open, Classified |
OJH | None listed |
| Jul 24, 2026 | Windstone Medical Packaging, Inc. AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as:
1) Laminectomy Pack, Pack Number AMS13574A;
2) ACDF/Fusion Pack, Pack Number AMS14710B;
3) Spine Pack, Pack Number AMS14991A;
4) Open, Classified |
OJH | None listed |
| Jul 23, 2026 | Medline Industries, LP Medline medical convenience kits labeled as:
1) TOTAL JOINT PACK Medline Kit SKU DYNJ65065A:
2) EXTREMITY/FOOT PACK Medline Kit SKU DYNJ65066B:
3) ANTERIOR CERVICAL-SMH Medline Kit SKU DYNJ907718B Open, Classified |
OJH | None listed |
| Jul 23, 2026 | Medline Industries, LP MEDLINE medical procedure convenience kit labeled as:
1) TOTAL KNEE-LF, Medline kit SKU CDSOPT590T;
2) TOTAL KNEE-LF, Medline kit SKU CDSOPT590U;
3) TOTAL KNEE CDS, Medline kit SKU CDS983930J;
4) Open, Classified |
OJH | None listed |
| Jul 22, 2026 | Medline Industries, LP MEDLINE convenience kits labeled as:
1) TOTAL JOINT KIT, Medline Kit SKU DYKS1574A;
2) TOTAL KNEE BASIC, Medline Kit SKU DYNJ902378J;
3) TOTAL HIP, Medline Kit SKU DYNJ903492K;
4) ANTERIOR HIP, M Open, Classified |
OJH | K213481 |
| Jul 15, 2026 | Medline Industries, LP Medline Kits containing Zimmer Biomet mixing bowls and spatulas
TOTAL KNEE PACK-LF
DYNJ61651J Open, Classified |
OJH | None listed |
| Jun 25, 2026 | Medline Industries, LP Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes.
CRANIOTOMY PACK-LF
DYNJ0101292F
DYNJ0101292G
HYBRID PACK
DYNJ65925A
LAMINECTOMY
DYNJ905156L
DYNJ905156M
DY Open, Classified |
OJH | None listed |
| Jun 17, 2026 | Medline Industries, LP MEDLINE Medical Procedure Kits labeled as:
1) CRANI, Medline Kit Number/SKU DYNJ908097;
2) CRANI, Medline Kit Number/SKU DYNJ908097A;
3) CRANI, Medline Kit Number/SKU DYNJ908097B;
4) CRANI, Medli Open, Classified |
OJH | None listed |
| Jun 12, 2026 | Medline Industries, LP Medline convenience kits:
ACD
DYNJ904999J
ACDF
DYNJ907336B
DYNJ910821A
ACDF PACK
DYNJ81098C
ACL
DYNJ911996
ACL ACCESSORY PACK
DYNJ86584B
ACL- LF
DYNJ905281B
ACL PACK
DYNJ67271A
ALIF
DYNJ904848 Open, Classified |
OJH | None listed |
| Jun 11, 2026 | AVID Medical, Inc. Halyard, Eye Bag Pack. Kit Code: UIEB48-01. Open, Classified |
OJH | None listed |
| Jun 11, 2026 | AVID Medical, Inc. Halyard, Drape Pack. Kit Code: LMDP36-01. Open, Classified |
OJH | None listed |
| Jun 11, 2026 | AVID Medical, Inc. Halyard, Pain Pack. Kit Code: AMPK48-01. Open, Classified |
OJH | None listed |
| May 28, 2026 | Medline Industries, LP Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as:
1) SPINAL ANESTHESIA TRAY-LF, Medline Kit SKU DYNJRA0102A;
2) SPINAL TRAY-LF, Medline Kit SKU DYNJRA0143B;
Open, Classified |
OJH | None listed |
| May 28, 2026 | Medline Industries, LP Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: SPINAL BLOCK 22G QUINCKE 5S BU, Medline Kit SKU DYNJRA9026 Open, Classified |
OJH | None listed |
| May 7, 2026 | Medline Industries, LP See RES for complete list. Medline Convenience Kits: 1) SPINAL CDS, Model Number: CDS940087AG; 2) SPINAL CDS, Model Number: CDS940087AI; 3) TOTAL HIP CDS-LF, Model Number: CDS980832Q; 4) TOTAL HIP CDS Open, Classified |
OJH | None listed |
| May 1, 2026 | AVID Medical, Inc. Halyard CATH LAB kit. Model Number: SACL75-01. Open, Classified |
OJH | None listed |
| Apr 30, 2026 | Medline Industries, LP Medline medical procedure kits, containing Medline Neuro Sponges (4077 in total), LAMINECTOMY, CRANI, etc. Open, Classified |
OJH | None listed |
| Apr 17, 2026 | Medline Industries, LP Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes
EXTREMITY PACK DYNJ34846C
HAND PACK DYNJ83218A, DYNJ85396
LAMINECTOMY DYNJ905156R
MAJOR EXTREMITY DYNJ9051 Open, Classified |
OJH | None listed |
| Apr 17, 2026 | Medline Industries, LP Medline Kits:
1) BWNBORO CRANIOTOMY PACK-LF, Model Number: DYNJ32841F;
2) CRANIOTOMY PACK-LF, Model Number: DYNJ46069D
3) CAMPUS EXTREMITY PK, Model Number: DYNJ51935A
4) FOOT -XRAY BOWL MEDCUP SPECC Open, Classified |
OJH | None listed |
| Apr 7, 2026 | Medline Industries, LP Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows:
1. SHOULDER ARTHROSCOPY PACK, Medline SKU # DYNJ30880M Open, Classified |
OJH | None listed |
| Apr 1, 2026 | Medline Industries, LP MEDLINE ANTERIOR HIP PACK
DYNJ64672B Open, Classified |
OJH | None listed |
| Feb 17, 2026 | Medline Industries, LP Medline Convenience Kits:
1) SPINAL CDS, Model Number: CDS940087AG;
2) SPINAL CDS, Model Number: CDS940087AI;
3) TOTAL HIP CDS-LF, Model Number: CDS980832Q;
4) TOTAL HIP CDS-LF, Model Number: CDS98 Open, Classified |
OJH | None listed |
| Jan 28, 2026 | Medline Industries, LP Medline medical procedure convenience kits labeled as:
1) WATKINS SPINE PACK-LF, Kit SKU DYNJ0275635M;
2) SM-SPINE PACK-LF, Kit SKU DYNJ0395037X;
3) TOTAL HIP PACK, Kit SKU DYNJ04809N;
4) MAIN/LA Open, Classified |
OJH | None listed |
| Jan 12, 2026 | Medline Industries, LP Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as:
1) RR-PLASTIC CRANIOFACIAL PK-LF, Medline kit SKU DYNJ0395085V;
2) NH PERI DISC PACK, Medline kit SK Open, Classified |
OJH | None listed |
| Nov 14, 2025 | Medline Industries, LP MEDLINE convenience kits labeled as:
1) NEURO CRANIOTOMY CDS #36-RF, REF CDS780119V;
2) BASIC BACK CDS, REF CDS780147N;
3) INSTRUMENTED BACK CDS, REF CDS780148R;
4) NEURO-LAMI CDS, REF CDS780208I Open, Classified |
OJH | None listed |
| Nov 13, 2025 | Medline Industries, LP Convenience kits;
DYNJ901047R ORTHO SPINE FUMICH
DYNJ902308K TOTAL JOINT
DYNJ909111F DR SALMA'S SPINE
DYNJ909117G PATTERSON TOTAL JOINT
DYNJ909113F KYPHOPLASTY Open, Classified |
OJH | None listed |
| Oct 16, 2025 | American Contract Systems Inc. Medical convenience kits
Item Number/Description
ANSH14AF SHOULDER PACK - 205962
EVAH76H ANTERIOR HIP PACK
FDSA15M SHOULDER ARTHROSCOPY
GRTS90G TOTAL SHPULDER PACK
HGHI26G HIP PINNING PACK
HJTO25C Open, Classified |
OJH | None listed |
| Sep 26, 2025 | Medline Industries, LP Sterile Medline Convenience Kits:
1) EXTREMITY PACK, Model Number: DYNJ45701B Open, Classified |
OJH | None listed |
| Aug 28, 2025 | American Contract Systems Inc AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as:
1) ANTERIOR HIP PACK, MODEL/ITEM NUMBER AMAH40N;
2)TOTAL KNEE DAN MYER, MODEL/ITEM NUMBER CCKM67F;
3)HIP PROTHESIS PACK, MOD Open, Classified |
OJH | None listed |
| Jun 6, 2025 | American Contract Systems, Inc. LOWER EXTREMITY, Model: NCEX20I;
LOWER EXTREMITY, Model: NCEX20J;
TOTAL KNEE PACK, Model: NCTK31K;
TOTAL KNEE PACK, Model: NCTK31L
All convenience kits contain Specialist Blend Cast Padding, Item: Q Open, Classified |
OJH | None listed |
| May 31, 2025 | MEDLINE INDUSTRIES, LP - Northfield Medline Kits containing Codman Disposable Perforator 14 mm:
1. CRANI ACCESSORY PACK
SKU DYNJ59270
2. CRANI PACK-LF
SKU DYNJ44805M
3. CRANIOTOMY
SKU CDS982719V
CDS982719W
DYNJ904168F
DYNJ908404B
D Open, Classified |
OJH | None listed |
| May 1, 2025 | MEDLINE INDUSTRIES, LP - Northfield Medline procedure kits, labeled as: HAND, REF DYNJ902002J Open, Classified |
OJH | None listed |
| Apr 17, 2025 | MEDLINE INDUSTRIES, LP - Northfield Refer to RES Open, Classified |
OJH | None listed |
| Mar 26, 2025 | MEDLINE INDUSTRIES, LP - Northfield Medline procedure kits labeled as:
1) ACL ARTHROSCOPY PACK, Pack Number DYNJ55316G;
2) ARTERIOGRAM PACK, Pack Number DYNJ64332;
3) ARTHRO PACK-LF, Pack Number DYNJ38748F;
4) ARTHRO PACK-LF, Pack Open, Classified |
OJH | None listed |
| Mar 14, 2025 | MEDLINE INDUSTRIES, LP - Northfield Proxima Drape labeled as ORTHO TRAUMA CDS, TOTAL KNEE AUX PACK, TOTAL HIP PACK, TOTAL HIP, TOTAL KNEE, SPINE. Sterile surgical drape. Open, Classified |
OJH | None listed |
| Mar 14, 2025 | American Contract Systems Inc TOTAL HIP PACK
, Model No SMTH06O
SMTH06P Open, Classified |
OJH | None listed |
| Mar 14, 2025 | American Contract Systems Inc HIP SCOPE, Model Nos.
CCHS21B
CCHS21B-01
CCHS21B-02 Open, Classified |
OJH | None listed |
| Feb 10, 2025 | Cardinal Health 200, LLC Cardinal Health Presource Kits:
1) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP11;
2) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP12
3) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP13
4) CHI S Open, Classified |
OJH | None listed |
| Jan 15, 2025 | Cardinal Health 200, LLC Cardinal Health Presource Kits:
1) ORTHO PLASTIC MICROVASCULAR PK , Catalog Number: PGVMFFBLY;
2) ORTHO PLASTIC MICROVASCULAR PK , Catalog Number: PGVMFFBLZ;
3) KIT,NEURO SPINE,ANDERSON , Catalog N Open, Classified |
OJH | None listed |
| Dec 30, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline custom medical procedure kits labeled as:
1) CRANI, REF CDS780089V;
2) CRANIOFACIAL CDS, REF CDS780102K;
3) CRANIOFACIAL CDS, REF CDS780102L;
4) CRANIOFACIAL CDS, REF CDS780102M;
5) CRAN Open, Classified |
OJH | None listed |
| Dec 20, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline brand, medical procedure convenience kits, labeled as: 1) LAMINECTOMY CDS-LF, SKU CDS780045N; 2) NEURO CRANIOTOMY CDS #36-RF, SKU CDS780119U; 3) NEURO CRANIOTOMY CDS #36-RF, SKU CDS780119V; Open, Classified |
OJH | None listed |
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