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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)
Feb 25, 2022Stradis Medical, LLC dba Stradis Healthcare
Coryell Memorial Hosp Total, Joint Pack - Surgical Kit
Open, Classified
OJHNone listed
Feb 25, 2022Stradis Medical, LLC dba Stradis Healthcare
Anterior Hip Pack - Surgical Kit
Open, Classified
OJHNone listed
Feb 25, 2022Stradis Medical, LLC dba Stradis Healthcare
Total Knee Pack - Surgical Kit
Open, Classified
OJHNone listed
Jan 13, 2022ROi CPS LLC
Regard, TOTAL HIP - SPRINGFIELD, Item No. 8800297010, Case Quantity: 2, Sterile
Terminated
OJHNone listed
Jul 1, 2021Medline Industries Inc
Medline Arthroscopy Kit, convenience kit, REF DYNJ904304B, containing expired component NaCl 3000mL Irrigation Bag (exp. date 08/01/2020).
Terminated
OJHNone listed
Jul 1, 2021Medline Industries Inc
Medline Total Knee, convenience kit, REF DYNJ907129B, containing expired component NaCl 3000mL Irrigation Bag (exp. date 08/01/2020).
Terminated
OJHNone listed
Jul 1, 2021Medline Industries Inc
Medline Knee Arthroscopy Kit, convenience kit, REF DYNJ902838C, containing expired component NaCl 3000mL Irrigation Bag (exp. date 08/01/2020).
Terminated
OJHNone listed
Jul 1, 2021Medline Industries Inc
Medline Shoulder CDS convenience kits, REF DYNJ902837D and REF DYNJ902837F, containing expired component NaCl 3000mL Irrigation Bag (exp. date 08/01/2020).
Terminated
OJHNone listed
Apr 13, 2020American Contract Systems
Sterile Custom Packs to be used in surgical procedures.
Terminated
OJHNone listed
Feb 18, 2020Avid Medical, Inc.
Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multiple item and lot numbers.
Terminated
OJHNone listed
Feb 11, 2020Medline Industries Inc
Medline HOI LUMBAR REF DYNJ902823G Lot 20AKA895 Expiration 2021-05-31 1 each GTIN (01)10193489219180
Terminated
OJHNone listed
Apr 14, 2016Customed, Inc
Catalog Number: 900982 ARTHROSCOPY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Terminated
OJHNone listed
Apr 14, 2016Customed, Inc
Catalog Number: 900742A CARPAL TUNEL LARGE SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc
Terminated
OJHNone listed
Apr 14, 2016Customed, Inc
Catalog Number: 900741A ORTHO-IMPLANT SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Terminated
OJHNone listed
Apr 14, 2016Customed, Inc
Catalog Number: 900740A ARTHROSCOPY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Terminated
OJHNone listed
Apr 14, 2016Customed, Inc
Catalog Number: 9002830 ORTHOPEDIC SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Terminated
OJHNone listed
Apr 14, 2016Customed, Inc
Catalog Number: 9002766 SHOULDER PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Terminated
OJHNone listed
Apr 14, 2016Customed, Inc
Catalog Number: 9002726 HIP AND KNEE REPLACEMENT SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate woun
Terminated
OJHNone listed
Apr 14, 2016Customed, Inc
Catalog Number: 9002615 EXTREMITY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Terminated
OJHNone listed
Apr 14, 2016Customed, Inc
Catalog Number: 9002614 HIP AND KNEE REPLACEMENT SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wound
Terminated
OJHNone listed
Apr 14, 2016Customed, Inc
Catalog Number: 9002609 ARTHOSCOPY PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Terminated
OJHNone listed
Apr 14, 2016Customed, Inc
Catalog Number: 9002193 SHOULDER ARTHROSCOPY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, e
Terminated
OJHNone listed
Apr 14, 2016Customed, Inc
Catalog Number: 9002164 FEMORAL SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Terminated
OJHK904694
Apr 14, 2016Customed, Inc
Catalog Number: 9002123 KNEE ARTHROSCOPY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Terminated
OJHNone listed
Apr 14, 2016Customed, Inc
Catalog Number: 9001298 PREMIUM ARTHROSCOPY PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Terminated
OJHNone listed
Apr 14, 2016Customed, Inc
Catalog Number: 9001202 LAMINECTOMY PK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Terminated
OJHNone listed
Apr 14, 2016Customed, Inc
Catalog Number: 9001062 ARTHROSCOPY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Terminated
OJHNone listed
Sep 3, 2015Customed, Inc
ARTHROSCOPY PK L/F 5/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate
Terminated
OJHNone listed
Sep 3, 2015Customed, Inc
CARPAL TUNEL LARGE SURGICAL PACK, 6/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Terminated
OJHNone listed
Sep 3, 2015Customed, Inc
ORTHO-IMPLANT SURGICAL PACK, Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Terminated
OJHNone listed
Sep 3, 2015Customed, Inc
ARTHROSCOPY SURGICAL PACK 4/C Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Terminated
OJHNone listed
Sep 3, 2015Customed, Inc
ORTHOPEDIC PACK BASIC 5/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Terminated
OJHNone listed
Sep 3, 2015Customed, Inc
SHOULDER PACK 3/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Terminated
OJHNone listed
Sep 3, 2015Customed, Inc
REEMPLAZO DE RODILLA Y CADERA 2/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Terminated
OJHNone listed
Sep 3, 2015Customed, Inc
SHOULDER ARTHROSCOPY PACK 2/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Terminated
OJHNone listed
Sep 3, 2015Customed, Inc
SHOULDER PACK 6/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Terminated
OJHNone listed
Sep 3, 2015Customed, Inc
EXTREMITY PACK 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Terminated
OJHNone listed
Sep 3, 2015Customed, Inc
HIP AND KNEE REPLACEMENT 3/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Terminated
OJHNone listed
Sep 3, 2015Customed, Inc
SHOULDER PACK (I) (2) 6/CS CUSTOMED Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Terminated
OJHNone listed
Sep 3, 2015Customed, Inc
SHOULDER ARTHROSCOPY PACK 3/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Terminated
OJHNone listed
Sep 3, 2015Customed, Inc
SHOULDER PACK CUSTOMED 3/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Terminated
OJHNone listed
Sep 3, 2015Customed, Inc
HIP ORTHO. PACK 3/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Terminated
OJHNone listed
Sep 3, 2015Customed, Inc
FEMORAL PACK 5/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Terminated
OJHK904694
Sep 3, 2015Customed, Inc
IMPLANTE DE ORTHOPEDIA 3/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Terminated
OJHNone listed
Sep 3, 2015Customed, Inc
LAMINECTOMY PACK 3/C Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Terminated
OJHNone listed
Dec 16, 2014Customed, Inc
Carpal Tunnel Surgical Large Pack, Catalog # 900-742A Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Terminated
OJHNone listed
Dec 16, 2014Customed, Inc
Transforaminal Lumbar Interbody Fusion (TLIF) pack, Catalog # 900-2918 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Terminated
OJHNone listed
Dec 16, 2014Customed, Inc
Orthopedic Pack, catalog #900-2830 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Terminated
OJHNone listed
Dec 16, 2014Customed, Inc
Shoulder Pack, catalog #900-2766 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Terminated
OJHNone listed
Dec 16, 2014Customed, Inc
Reemplazo de Rodilla y Cadera Knee and Hip Replacement tray, Catalog #2726 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Terminated
OJHNone listed

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