ClearanceBrief
Panels › General, Plastic Surgery › Product code KDD · Class 1

Kit, Surgical Instrument, Disposable

Regulation 878.4800

0510(k)s in 12 months (62 all time)
16recalls in 12 months (252 all time)
9recalls that name a 510(k)
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Top companies in KDD

DateFirm and productCodeLinked 510(k)
Aug 3, 2023MEDLINE INDUSTRIES, LP - Northfield
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CATH LAB BASIN PACK, Model Number: DYNJ69864A; b. DELNOR VASCULAR BASIN PACK, Mode
Open, Classified
KDDNone listed
Jul 20, 2023MEDLINE INDUSTRIES, LP - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: CATH LAB BASIN PACK, Model Number DYNJ69864A
Open, Classified
KDDNone listed
Jul 3, 2023DeRoyal Industries Inc
Custom medical procedure packs labeled as: a) STANDARD OB PACK ASCENSION WI, REF 89-10640 b) ANGIO PACK, REF 89-10901 c) BASIN, REF 89-1924 d) CYSTO PACK, REF 89-7133 e) TOTAL HIP PACK, REF 89-9134
Open, Classified
KDDNone listed
May 23, 2023Windstone Medical Packaging, Inc.
Aligned Medical Solutions Hand Pack, REF: AmS4601E, containing P 2 Cover Light Handle Blue STE, Sterile EO
Open, Classified
KDDNone listed
May 23, 2023Windstone Medical Packaging, Inc.
Aligned Medical Solutions Minor Hand Pack, REF: AMS6539E, containing P 2 Cover Light Handle Blue STE, Sterile EO
Open, Classified
KDDNone listed
May 23, 2023Windstone Medical Packaging, Inc.
Aligned Medical Solutions Spine Pack, REF: AMS4599(C, containing P 2 Cover Light Handle Blue STE, Sterile EO
Open, Classified
KDDNone listed
Mar 1, 2023Beaver Visitec International, Inc.
CustomEyes kits
Open, Classified
KDDNone listed
Feb 10, 2023MEDLINE INDUSTRIES, LP - Northfield
Surgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS L & D TRAY, Reorder Number MNS9065
Open, Classified
KDDNone listed
Feb 6, 2023MEDLINE INDUSTRIES, LP - Northfield
Sterile Procedural Trays, labeled as the following: a. ST. ANNE'S MAJOR BASIN SET UP b. SINGLE BASIN SET c. DOUBLE BASIN SET d. LAPAROTOMY BASIN e. ORTHOPEDIC CUSTOM BASIN SET f. OISC BASIN TRAY g.
Open, Classified
KDDNone listed
Jan 4, 2023Windstone Medical Packaging, Inc.
Various Custom Surgical Instrument Disposable Kits: Part Numbers / Product Description 26000004M Custom Lasik Kit AMS10411A Nasal Endoscopy Pack AMS10710A Ultrasound Tray w/PDI AMS11941 Total Knee Pac
Open, Classified
KDDNone listed
Mar 21, 2022Windstone Medical Packaging, Inc.
Prevantics swabs and/or swabsticks contained inside the following Aligned Medical Solutions convenience kits with Name/Pack numbers: Ports Cath Pack (1794)/AMS6569, Minor Procedure Pack (20527)/AMS65
Open, Classified
KDDNone listed
May 11, 2021Medical Action Industries, Inc. 306
Medical Action INDUSTRIES INC., General Purpose Instrument Tray, REF 61209
Terminated
KDDNone listed
May 11, 2021Medical Action Industries, Inc. 306
novaplus, General Purpose Kit, Cat. No. 56603
Terminated
KDDNone listed
Apr 8, 2021Windstone Medical Packaging, Inc.
Angio Pack REF: AMS8050A, Sterile EO, Contents:2 Glove Dermassist 7.5 PF PR S 1 Bowl Fluid Containment W/LI 1 Cover Probe 6 X 48 NS 2 Gown surgical STD XLG NR 1 Needle RB 18x1.5 1 Spike Bag Decanter
Terminated
KDDNone listed
Apr 8, 2021Windstone Medical Packaging, Inc.
Angio Pack REF: AMS6908C, Sterile EO, Contents:1 Blade Scalpel # 11 SS 1 Bowl Guidewire 80 oz 4 Clamp Towel 2.5 1 Cover Probe 6X48 NS 2 Gown Surgical STD XLG NR 16 Label Custom 1 Counter Needle Nest
Terminated
KDDNone listed
Mar 23, 2021Bioseal Corporation
Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, REF: CVC009/20, Sterile EO, Single Use Only, UDI: (01)00630094430096
Completed
KDDNone listed
Mar 23, 2021Bioseal Corporation
Bioseal, Chest Tube Insertion Tray, containing ChloraPREP Applicator 3 mL, REF: CHT017/20, Sterile EO, Single Use Only, UDI: (01)10630094820177
Completed
KDDNone listed
Mar 23, 2021Bioseal Corporation
Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, REF: CVC015/20, Sterile EO, UDI: (01)00630094430157
Completed
KDDNone listed
Apr 24, 2020DeRoyal Industries Inc
DeRoyal Sterile Custom Kits packaged as a Piggy Back with the BD PosiFlush SF Saline Flush Syringe, labeled as follows: a. H* Vein Pack Pgybk, 89-6209.03 b. H* Vein Pack, 89-6209.04 c. PICC Line
Terminated
KDDNone listed
Jan 6, 2020Medical Action Industries, Inc. 306
Medical convenience trays and kits, labeled as: Medical Action Industries, Inc.: ***CVC*** Clear Sequence Change Kit, REF 77070B ***DIALYSIS*** Clear Sequence Change Kit, REF 77068B ***PEDS CVC*** C
Terminated
KDDNone listed
Mar 21, 2019ROi Consolidated Service Center (CSC)
Regard custom surgical pack labeled as "LAPAROSCOPIC - OSU" including recalled Stryker part numbers 0620 040 660 Pneumosure High Flow II Tubeset, 0620 040 690 Pneumosure Heated Tubeset with RTP and 0
Open, Classified
KDDNone listed
Mar 21, 2019ROi Consolidated Service Center (CSC)
Regard custom surgical pack labeled as "LAP - FLOL LADY OF ANGELS" including recalled Stryker part numbers 0620 040 660 Pneumosure High Flow II Tubeset, 0620 040 690 Pneumosure Heated Tubeset with RT
Open, Classified
KDDNone listed
Apr 11, 2018Arrow International Inc
Maximal Barrier Drape; Product Code: ASK-01000-UPMS
Terminated
KDDK870572
Apr 11, 2018Arrow International Inc
Maximal Barrier Drape; Product Codes: ASK-00376-SU
Terminated
KDDK874063
Nov 17, 2017Stryker Corporation
ACL DISPOSABLE PACK BONE-TENDON-BONE, Model 0234020280, labeled sterile.
Terminated
KDDNone listed
Oct 24, 2017Arrow International Inc
Pneumothorax Kit
Terminated
KDDK904021
Oct 24, 2017Arrow International Inc
ArrowClarke" PleuraSeal Thoracentesis Kit
Terminated
KDDK870572
Oct 24, 2017Arrow International Inc
Large Volume Abdominal Paracentesis Kit
Terminated
KDDK874063
Oct 18, 2017Bioseal Corporation
Custom surgical kits labeled as follows: (a) Suture Removal Set, 910-0002 (b) Instrument Set, INST03/20 (c) Suture Removal Set, SUT309/100 (d) Incision & Drainage Tray, INC03/20 (e) Suture Remova
Completed
KDDNone listed
Nov 6, 2015Utah Medical Products, Inc
Myelo-Nate CSF Sampling Kit, Neonatal/Pediatric cerebralspinal fluid sampling sterile tray, including a lumbar puncture needle, four collection vials, an iodine swabstick package, a fenestrated drape,
Terminated
KDDK821814
Nov 2, 2015Windstone Medical Packaging, Inc.
AMS 4675 Angio Pack. For use in a general clinical procedure.
Terminated
KDDNone listed
Nov 2, 2015Windstone Medical Packaging, Inc.
AMS 4674 Custom Pack. For use in a general clinical procedure.
Terminated
KDDNone listed
May 11, 2013Covidien LLC
Curity Staple Remover Kit; Product Code: 66701. Staple Remover Kit.
Terminated
KDDK761193
Apr 17, 2012Deroyal Industries, Inc. Lafollette
Sterile sterile surgical kits containing Episeal products, packaged as follows: DeRoyal CLINIC PICC KIT, REF 47-483, STERILE EO, Rx Only, Manufactured by: DeRoyal Industries, 200 DeBusk Lane, Powell T
Terminated
KDDNone listed
Jul 19, 2011Biomet Microfixation, Inc.
"***REF: 24-4050 TMJ SYSTEM ArthroSimplicity KIT***STERILE PRODUCT***STERILE EO***KIT CONTAINS BOTH STERILE AND NON-STERILE COMPONENTS DISTRIBUTED BY: BIOMET MICROFIXATION 1520 TRADEPORT DRIVE JACKS
Terminated
KDDNone listed
Jul 19, 2011Biomet Microfixation, Inc.
"***REF: 922090 TMJ SYSTEM InnerVue SCOPE PROCEDURE KIT***STERILE PRODUCT***STERILE EO***KIT CONTAINS BOTH STERILE AND NON-STERILE COMPONENTS DISTRIBUTED BY: BIOMET MICROFIXATION 1520 TRADEPORT DRI
Terminated
KDDNone listed
Jul 19, 2011Biomet Microfixation, Inc.
"***REF: 24-3050 TMJ SYSTEM OnPoint SCOPE PROCEDURE KIT***STERILE PRODUCT***STERILE EO***KIT CONTAINS BOTH STERILE AND NON-STERILE COMPONENTS Distributed by: BIOMET MICROFIXATION 1520 TRADEPORT DRI
Terminated
KDDNone listed
Jul 19, 2011Biomet Microfixation, Inc.
"***REF: 922070 TMJ SYSTEM ARTHROSIMPLICITY KIT***STERILE PRODUCT***STERILE EO***DISTRIBUTED BY BIOMET MICROFIXATION 1520 TRADEPORT DRIVE JACKSONVILLE, FL 32218 USA www.biometmicrofixation.com***"
Terminated
KDDNone listed
Dec 15, 2009Biomet Microfixation, Inc.
BD Recalled component is labeled: BD 60ml Syringe Luer-Lok Tip, REF 309653 STERILE. BD Franklin Lakes, NJ 07417 USA Made in USA , www.bd.com. Lots 7298534 Exp 2012-10 and 7334153 Exp 2012-11. Compo
Terminated
KDDNone listed
Dec 15, 2009Biomet Microfixation, Inc.
BD Recalled component is labeled: BD 60ml Syringe Luer-Lok Tip, REF 309653 STERILE. BD Franklin Lakes, NJ 07417 USA Made in USA , www.bd.com. Lots 7298534 Exp 2012-10 and 7334153 Exp 2012-11. Compo
Terminated
KDDNone listed
Dec 15, 2009Biomet Microfixation, Inc.
BD Recalled component is labeled: BD 60ml Syringe Luer-Lok Tip, REF 309653 STERILE. BD Franklin Lakes, NJ 07417 USA Made in USA , www.bd.com. Lots 7298534 Exp 2012-10 and 7334153 Exp 2012-11. Compo
Terminated
KDDNone listed
Dec 15, 2009Biomet Microfixation, Inc.
BD Recalled component is labeled: BD 60ml Syringe Luer-Lok Tip, REF 309653 STERILE. BD Franklin Lakes, NJ 07417 USA Made in USA , www.bd.com. Lots 7298534 Exp 2012-10 and 7334153 Exp 2012-11. Compo
Terminated
KDDNone listed
Dec 15, 2009Biomet Microfixation, Inc.
BD Recalled component is labeled: BD 60ml Syringe Luer-Lok Tip, REF 309653 STERILE. BD Franklin Lakes, NJ 07417 USA Made in USA , www.bd.com. Lots 7298534 Exp 2012-10 and 7334153 Exp 2012-11. Compo
Terminated
KDDNone listed
Nov 23, 2009Merit Medical Systems, Inc.
Merit Medical Systems, Inc., Convenience Trays, custom packaged under the following Merit Medical labels: (1) Prentice PICC Kit, Catalog number K12T-03698; (2) Insertion Kit, catalog number K12T-03050
Terminated
KDDK984558
Apr 30, 2009Tri-State Hospital Supply Corporation
Tri-State Centurion Incision and Drainage Tray, sterile, 20 per case, Tri-State Hospital Supply Corp., Howell, MI; Reorder ID615.
Terminated
KDDNone listed
Nov 7, 2008DeRoyal Industries Inc
DeRoyal Lap Chole Tray, REF 89-4823.06, Rx, Sterile EO. (custom surgical kit)
Terminated
KDDNone listed
Nov 7, 2008DeRoyal Industries Inc
DeRoyal Lap Appy TraceCart, REF53-1776, Rx only, non-sterile. (custom surgical kit)
Terminated
KDDNone listed
Sep 19, 2008Merit Medical Systems, Inc.
Arnot-Ogden Med Ctr Hip Pack, REF: K12T-02159A, Sterile, Merit Medical Systems, Inc., 1600 West Merit Parkway, South Jordan, Utah 84095. A combination of legally marketed medical devices placed into
Terminated
KDDNone listed
Sep 19, 2008Merit Medical Systems, Inc.
Arnot-Ogden Med Ctr Hip Pack, REF: K12T-02160A, Sterile, Merit Medical Systems, Inc., 1600 West Merit Parkway, South Jordan, Utah 84095. A combination of legally marketed medical devices placed into
Terminated
KDDNone listed
Sep 11, 2008Merit Medical Systems, Inc.
CABG PACK, Surgical Convenience Kit, Sterile, Reorder #:K12T-02449B, Merit Medical Systems, Inc., 1600 West Merit Parkway, South Jordan, Utah 84095. A combination of legally marketed medical devices p
Terminated
KDDNone listed

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