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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)
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Top companies in OJH

DateFirm and productCodeLinked 510(k)
Jul 5, 2024American Contract Systems Inc
ARTHO KNEE BAPTIST SOUTH PACK Procedure tray Catalog Number: BPKA49B
Open, Classified
OJHNone listed
Jul 5, 2024American Contract Systems Inc
ARTHROSCOPY SUP JOI PACK Procedure tray Catalog Number: BPAS17C
Open, Classified
OJHNone listed
Jul 5, 2024American Contract Systems Inc
ARTHROSCOPY WOLFSON PACK BHS Procedure tray Catalog Number: BPAR65A
Open, Classified
OJHNone listed
Jul 5, 2024American Contract Systems Inc
TOTAL KNEE - 247546 Procedure tray Catalog Number: BFTK01Z
Open, Classified
OJHNone listed
Jul 5, 2024American Contract Systems Inc
TOTAL KNEE - 247546 - Procedure tray Catalog Number: BFTK01AA
Open, Classified
OJHNone listed
Jul 5, 2024American Contract Systems Inc
LOWER EXTREMITY - 247542- Procedure tray Catalog Number: BFLE56X
Open, Classified
OJHNone listed
Jul 5, 2024American Contract Systems Inc
MAJOR KNEE - 302497- Procedure tray Catalog Number: ASKN23B
Open, Classified
OJHNone listed
Jul 5, 2024American Contract Systems Inc
TOTAL KNEE - 302497- Procedure tray Catalog Number: ANTK12AF
Open, Classified
OJHNone listed
Jul 5, 2024American Contract Systems Inc
AHAR50K STANDARD ARTHROSCOPY PACK - 291852. Procedure tray Catalog Number: AHAR50K
Open, Classified
OJHNone listed
May 29, 2024MEDLINE 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
OJHNone listed
Feb 25, 2024MEDLINE 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
OJHNone listed
Jan 26, 2024American 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
OJHNone listed
Oct 10, 2023Cardinal 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
OJHNone listed
Aug 10, 2023MEDLINE INDUSTRIES, LP - Northfield
Total Hip Kit, REF DYNJ903275S; surgical convenience kit
Open, Classified
OJHNone listed
Aug 3, 2023MEDLINE 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
OJHNone listed
Jul 20, 2023MEDLINE 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
OJHNone listed
Jul 20, 2023MEDLINE 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
OJHNone listed
Jun 15, 2023American Contract Systems, Inc.
Total Knee Pack, REF CETJ130, medical convenience kits
Open, Classified
OJHNone listed
May 26, 2023MEDLINE 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
OJHNone listed
Apr 25, 2023ROi 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
OJHNone listed
Feb 23, 2023MEDLINE 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
OJHNone listed
Feb 10, 2023MEDLINE 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
OJHNone listed
Feb 10, 2023MEDLINE INDUSTRIES, LP - Northfield
Surgical convenience kits labeled as: MEDLINE SHOULDER SUSPENSION I-LF, Reorder Number DYNJSHOULDER
Open, Classified
OJHNone listed
Feb 6, 2023MEDLINE 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
OJHNone listed
Jan 27, 2023MEDLINE INDUSTRIES, LP - Northfield
Non-sterile procedural trays labeled as TOTAL KNEE KIT, 1 per case
Open, Classified
OJHNone listed
Jan 27, 2023MEDLINE INDUSTRIES, LP - Northfield
Non-sterile procedural trays labeled as THEDA CLARK TOTAL KNEE CDS, 1 per case
Open, Classified
OJHNone listed
Jan 27, 2023MEDLINE INDUSTRIES, LP - Northfield
Non-sterile procedural trays labeled as ORTHO TRAUMA, 1 per case
Open, Classified
OJHNone listed
Jan 27, 2023MEDLINE INDUSTRIES, LP - Northfield
Non-sterile procedural trays labeled as CRANI, 2 per case
Open, Classified
OJHNone listed
Dec 14, 2022Stradis Medical, LLC dba Stradis Healthcare
HENRY SCHEIN, EXTREMITY PACK, Item No.570-2946
Open, Classified
OJHNone listed
Dec 14, 2022Stradis Medical, LLC dba Stradis Healthcare
HENRY SCHEIN, Knee Pack, Item No.570-2908,
Open, Classified
OJHNone listed
Dec 14, 2022Stradis Medical, LLC dba Stradis Healthcare
HENRY SCHEIN, MAJOR EXTREMITY PACK, Item No.570-2783,
Open, Classified
OJHNone listed
Nov 23, 2022ROi CPS LLC
regard SHOULDER ARTHROSCOPY, OR01103A, Item Number 880471001; ortho surgery convenience kit
Terminated
OJHNone listed
Nov 23, 2022ROi CPS LLC
regard SPINE, OR01100A, Item Number 880468001; ortho surgery convenience kit
Terminated
OJHNone listed
Nov 23, 2022ROi CPS LLC
regard HIP ARTHROSCOPY, OR01092B, Item Number 880462002; ortho surgery convenience kit
Terminated
OJHNone listed
Nov 23, 2022ROi CPS LLC
regard LATERAL SHOULDER, OR01044C, Item Number 880435003; ortho surgery convenience kit
Terminated
OJHNone listed
Nov 23, 2022ROi CPS LLC
regard SHOULDER, GS00828G, Item Number 880367007; ortho surgery convenience kit
Terminated
OJHNone listed
Nov 23, 2022ROi CPS LLC
regard SHOULDER PACK, GS00125V, Item Number 880120022; ortho surgery convenience kit
Terminated
OJHNone listed
Nov 23, 2022ROi CPS LLC
regard SHOULDER PK, GS00125U, Item Number 880120021; ortho surgery convenience kit
Terminated
OJHNone listed
Nov 23, 2022ROi CPS LLC
regard FOOT PACK - MERCY SPRINGFIELD , OR00123Z, Item Number 880118026; ortho surgery convenience kit
Terminated
OJHNone listed
Nov 23, 2022ROi CPS LLC
regard SHOULDER ARTHROSCOPY, OR00049Q, Item Number 880044017; ortho surgery convenience kit
Terminated
OJHNone listed
Nov 23, 2022ROi CPS LLC
regard TOTAL HIP ARTHROPLASTY A&B, OR00032W, Item Number 880028023; ortho surgery convenience kit
Terminated
OJHNone listed
Nov 23, 2022ROi CPS LLC
regard HAND PACK, OR00594K, Item Number 800243011; ortho surgery convenience kit
Terminated
OJHNone listed
Nov 23, 2022ROi CPS LLC
regard SHOULDER W BCH CHAIR, OR00356F, Item Number 800203006; ortho surgery convenience kit
Terminated
OJHNone listed
Nov 23, 2022ROi CPS LLC
regard SPINE PACK, NU00260H, Item Number 800022008; ortho surgery convenience kit
Terminated
OJHNone listed
Nov 23, 2022ROi CPS LLC
regard KYPHOPLASTY, OR01101, Item Number 880469; orthopedic surgery convenience kit
Terminated
OJHNone listed
Nov 23, 2022ROi CPS LLC
regard TOTAL JOINT, OR00446F, Item Number 880291; orthopedic surgery convenience kit
Terminated
OJHNone listed
Nov 23, 2022ROi CPS LLC
regard FOOT PACK, OR00123Y, Item Number 880118; orthopedic surgery convenience kit
Terminated
OJHNone listed
Jun 16, 2022American Contract Systems, Inc.
Various convenience packs
Open, Classified
OJHNone listed
Jun 6, 2022MEDLINE INDUSTRIES, LP - SPT
MEDLINE INDUSTRIES, LP - SPT:
Open, Classified
OJHNone listed
Mar 22, 2022American Contract Systems, Inc.
1) ACS Arthroscopy Kit 2) ACS Knee Kit 3) ACS Hand Pack
Open, Classified
OJHNone listed

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