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

Plastic Surgery And Accessories Kit

Regulation 878.3925

0510(k)s in 12 months (0 all time)
15recalls in 12 months (63 all time)
0recalls that name a 510(k)
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Top companies in FTN

DateFirm and productCodeLinked 510(k)
Aug 31, 2026Medline Industries, LP
Medline Convenience Kits: 1) ULTRASOUND BREAST PACK, Model Number: DYNJ63375C
Open, Classified
FTNNone listed
Aug 26, 2026Medline Industries, LP
Medline convenience kits labeled as: LTP CDS-LF, Medline kit SKU CDS980375M
Open, Classified
FTNNone listed
Jun 25, 2026Medline Industries, LP
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. DR G'S BREAST PACK DYNJ51124B LIPO SUPPLEMENT PACK-LF DYNJ0341174D PLASTIC PACK DYNJ66746 DYNJ85702
Open, Classified
FTNNone listed
Jun 17, 2026Medline Industries, LP
MEDLINE Medical Procedure Kits labeled as: 1) KIT UROLOGY URETHROPLASTY, Medline Kit Number/SKU DYKMBNDL117C; 2) URETHROPLASTY, Medline Kit Number/SKU DYNJ908978; 3) URETHROPLASTY, Medline Kit Num
Open, Classified
FTNNone listed
Jun 12, 2026Medline Industries, LP
Medline convenience kits: BREAST IMAGING DYNJT5893 CHOG PLASTICS SYNJ10306A ENDO BREAST AUGMENTATION PACK DYNJ68023 FACIAL PLASTIC DYNJ909926C JVL - MODULE PLASTIC PK DYNJ84081B KIT MAJOR PLASTI
Open, Classified
FTNNone listed
May 7, 2026Medline Industries, LP
See RES for complete list. Medline Convenience Kits: 1) PLASTIC BIN W/MISC KITS, Model Number: ACC010499; 2) BREAST-HERNIA-PORT CDS-LF, Model Number: CDS984853J; 3) KIT UROLOGY URETHROPLASTY, Model Nu
Open, Classified
FTNNone listed
Apr 30, 2026Medline Industries, LP
Medline medical procedure kits, containing Medline Neuro Sponges (102 in total)
Open, Classified
FTNNone listed
Apr 17, 2026Medline Industries, LP
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes FACE/RHINOPLASTY PACK DYNJ80343C PLASTIC HEAD-NECK PACK DYNJ86639
Open, Classified
FTNNone listed
Apr 17, 2026Medline Industries, LP
Medline Kits: 1) BREAST PACK, Model Number: DYNJ66777D
Open, Classified
FTNNone listed
Apr 7, 2026Medline Industries, LP
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: MINOR PLASTIC-LF, Medline Kit SKU # DYNJ86596
Open, Classified
FTNNone listed
Feb 17, 2026Medline Industries, LP
Medline Convenience Kits: 1) PLASTIC BIN W/MISC KITS, Model Number: ACC010499; 2) KIT UROLOGY URETHROPLASTY, Model Number: DYKMBNDL117C; 3) KIT PLASTIC INSERT TISSUE EXPA, Model Number: DYKMBNDL158;
Open, Classified
FTNNone listed
Jan 28, 2026Medline Industries, LP
Medline medical procedure convenience kits labeled as: 1) MEM MAXILLOFACIAL PACK-LF, Kit SKU DYNJ0660040R; 2) PLASTICS VCH, Kit SKU DYNJ39225K; 3) WT BREAST PACK, Kit SKU DYNJ46620I; 4) ENDO / AU
Open, Classified
FTNNone listed
Jan 12, 2026Medline Industries, LP
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: DR HOLCOMB FACIAL PACK, Medline kit SKU DYNJ54488A
Open, Classified
FTNNone listed
Nov 14, 2025Medline Industries, LP
MEDLINE convenience kits labeled as: 1) ACH PLASTICS BREAST-LF, REF CDS983639K; 2) BREAST ABD, REF CDS984267J; 3) PLASTIC PACK, REF DYNJ00264M; 4) BREAST ABDOMINOPLASTY MZ PK-LF, REF DYNJ0428947L
Open, Classified
FTNNone listed
Nov 13, 2025Medline Industries, LP
Convenience Kit, BREAST HERNIA DYNJ909125G
Open, Classified
FTNNone listed
Apr 17, 2025MEDLINE INDUSTRIES, LP - Northfield
Medline Convenience kits used for various procedures: 1) OCULOPLASTIC PICK PACK, Model Number: DYNJ43914B; 2) PLASTIC PACK, Model Number: DYNJ65109; 3) PLASTIC PROCEDURE PACK, Model Number: DYNJ3416
Open, Classified
FTNNone listed
Mar 26, 2025MEDLINE INDUSTRIES, LP - Northfield
Medline procedure kits labeled as: 1) BREAST PACK-LF, Pack Number DYNJ0956628O; 2) BREAST SURGERY FOAKS, Pack Number DYNJ63577C; 3) CHEST BREAST -LF, Pack Number DYNJCEN04C; 4) DIEP PACK, Pack Nu
Open, Classified
FTNNone listed
Mar 14, 2025MEDLINE INDUSTRIES, LP - Northfield
Proxima Drape labeled as FACE LIFT. Sterile surgical drape.
Open, Classified
FTNNone listed
Dec 30, 2024MEDLINE INDUSTRIES, LP - Northfield
Medline custom medical procedure kits labeled as: 1) MEM MAXILLOFACIAL PACK-LF, REF DYNJ0660040R; 2) FREE FLAP PACK-LF, REF DYNJ42833A; 3) FREE FLAP PACK-LF, REF DYNJ42833B; 4) TYMPANOPLASTY PACK, R
Open, Classified
FTNNone listed
Dec 20, 2024MEDLINE INDUSTRIES, LP - Northfield
SEPTOPLASTY PACK Convenient kit, SKU DYNJ44759F. Convenience kits used for various procedures.
Open, Classified
FTNNone listed
Dec 5, 2024MEDLINE INDUSTRIES, LP - Northfield
MEDLINE convenience kits labeled as: 1) MAMMOPLASTY-LF, REF CDS983478L; 2) MAMMOPLASTY-LF, REF CDS983478M; 3) PLASTICS FREE FLAP, REF CDS983493M; 4) PLASTIC TORSO-LF, REF CDS983496L; 5) PLASTIC
Open, Classified
FTNNone listed
Oct 23, 2024MEDLINE INDUSTRIES, LP - Northfield
Medline brand medical procedure convenience kits, labeled as: a) PLASTIC PACK, REF DYNJ42735A; b) DR SELEM PACK, REF DYNJ43457; c) BREAST PK TEGH-LF, REF DYNJ46717A; d) BREAST PK TEGH-LF, REF DYN
Open, Classified
FTNNone listed
Sep 11, 2024MEDLINE INDUSTRIES, LP - Northfield
Medline convenience kits containing semi-rigid suction liners labeled as follows: a) MINOR BREAST, Pack Number DYNJ908104B; b) PLASTIC MAJOR, Pack Number DYNJ908106B; c) ABDOMINOPLASTY W/LIPO SUCT
Open, Classified
FTNNone listed
Sep 6, 2024MEDLINE INDUSTRIES, LP - Northfield
Medline Convenience kits labeled as: 1) CHEST EXPLORATION CDS , Pack Number CDS920066K ; 2) CHEST EXPLORATION CDS , Pack Number CDS920066L ; 3) PLASTIC SMR CDS-LF, Pack Number CDS980088K ; 4) PLA
Open, Classified
FTNNone listed
Aug 28, 2024MEDLINE INDUSTRIES, LP - Northfield
Medline procedural kits labeled as: 1) BOTOX KIT - CHRONIC MIGRAINE, Pack Number DYKM2000; 2) BREAST, Pack Number DYNJ902703K; 3) ENT TYMPANOPLASTY PACK-LF , Pack Number DYNJ38988J; 4)FREE FLAP T
Open, Classified
FTNNone listed
Aug 22, 2024MEDLINE INDUSTRIES, LP - Northfield
Medline medical procedure kits labeled as follows: a) MAJOR BREAST, REF DYNJ905004C; b) MINOR BREAST, REF DYNJ905002B; c) SUCTION MEDI VAC, REF DYKM2033
Open, Classified
FTNNone listed
Feb 25, 2024MEDLINE INDUSTRIES, LP - Northfield
Medline Kits, trays, and packs labeled as follows: a) BREAST PACK, REF DYNJ56344B; b) SEPTOPLASTY PACK WRO-LF, REF DYNJ62803
Open, Classified
FTNNone listed
Jan 26, 2024American Contract Systems, Inc.
Custom procedural convenience kits and trays, general & plastic surgery, labeled as: a) Breast Plastics Pack, kit number BBPL20D; b) MINOR PLASTIC, kit number WPMP16H
Open, Classified
FTNNone listed
Oct 26, 2023American Contract Systems, Inc.
Breast Plastics Pack, REF BBPL20D
Open, Classified
FTNNone listed
Aug 3, 2023MEDLINE INDUSTRIES, LP - Northfield
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. (54) KIT STC PLASTIC FREE FLAP, Model Number: DYNJ909031; b. BREAST, Model Number:
Open, Classified
FTNNone listed
Jul 20, 2023MEDLINE INDUSTRIES, LP - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) BREAST PACK, Model Number DYNDH1306; b) BRST BX TRAY, Model Number DYNDH1389B; c) PLASTIC PACK, Model Numbe
Open, Classified
FTNNone listed
Feb 10, 2023MEDLINE INDUSTRIES, LP - Northfield
Surgical convenience kits labeled as: MEDLINE PLASTICS/PEDS KIT, Reorder Number DYNDA2489
Open, Classified
FTNNone listed
Feb 6, 2023MEDLINE INDUSTRIES, LP - Northfield
Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST REDUCTION CDS c. CUH ABDOMINOPLASTY CDS d. ACH PLASTICS BREAST-LF e. NE BREAST RECON CDS f. PLASTIC SURGERY CDS g
Open, Classified
FTNNone listed
Dec 14, 2022Stradis Medical, LLC dba Stradis Healthcare
STRADIS HEALTHCARE, Breast, Item No.693-276,
Open, Classified
FTNNone listed
Dec 14, 2022Stradis Medical, LLC dba Stradis Healthcare
STRADIS HEALTHCARE, Thoracic Phleb, Item No.682-1228,
Open, Classified
FTNNone listed
Dec 14, 2022Stradis Medical, LLC dba Stradis Healthcare
STRADIS HEALTHCARE, Lipo, Item No.681-254,
Open, Classified
FTNNone listed
Dec 14, 2022Stradis Medical, LLC dba Stradis Healthcare
HENRY SCHEIN, RHINO PACK, Item No.570-3070
Open, Classified
FTNNone listed
Dec 14, 2022Stradis Medical, LLC dba Stradis Healthcare
HENRY SCHEIN, BREAST PACK, Item No.570-2397
Open, Classified
FTNNone listed
Dec 14, 2022Stradis Medical, LLC dba Stradis Healthcare
HENRY SCHEIN, Breast Augmentation tray, Item No.570-0611
Open, Classified
FTNNone listed
Jun 16, 2022American Contract Systems, Inc.
Breast Abdominoplasty Pack
Open, Classified
FTNNone listed
Apr 20, 2020ROi CPS LLC
Regard. Item number: 830034. GS0348D- CVC Triple Lumen 20CM non Sulfa-Mercy.
Terminated
FTNNone listed
Apr 13, 2020American Contract Systems
Sterile Custom Packs to be used in surgical procedures.
Terminated
FTNNone listed
Aug 29, 2012SRI Surgical
Various SRI Surgical Disposable Accessory Packs. SRI's Disposable Accessory Packs (also commonly known as convenience kits and custom procedure trays) are an assembly of medical devices packaged toge
Terminated
FTNNone listed
Apr 27, 2011Argon Medical Devices, Inc
Argon Medical Devices, Arterial Line Kit/1, 18ga x 6", Part Number 498447, Lot number 99767634 Multi-purpose Kit blister tray coupled with Tyvek lid stock heat-sealed to form a sterile barrier.
Terminated
FTNNone listed
Apr 27, 2011Argon Medical Devices, Inc
Argon Medical Devices, Arterial Line Kit 20ga x 3", Part Number 498421B, Lot number 99766896 Multi-purpose Kit blister tray coupled with Tyvek lid stock heat-sealed to form a sterile barrier.
Terminated
FTNNone listed
Apr 27, 2011Argon Medical Devices, Inc
Argon Medical Devices Arterial Line Kit, 18ga x 6", Part Number 498412B, Lot number 99767958 Multi-purpose Kit blister tray coupled with Tyvek lid stock heat-sealed to form a sterile barrier.
Terminated
FTNNone listed
Apr 27, 2011Argon Medical Devices, Inc
Argon Medical Devices, Arterial Line Kit, Part Number 498410B, 20gax6", Lot number 99767653 Multi-purpose Kit blister tray coupled with Tyvek lid stock heat-sealed to form a sterile barrier.
Terminated
FTNNone listed
Apr 27, 2011Argon Medical Devices, Inc
Argon Medical Devices, Catheter Introducer Kit 5F, Part Number 496190A, Lot number 99766894 Multi-purpose Kit blister tray coupled with Tyvek lid stock heat-sealed to form a sterile barrier. For perc
Terminated
FTNNone listed
Apr 27, 2011Argon Medical Devices, Inc
Argon Medical Devices, Arterial Line Kit, 18ga x 6", Part Number 498443, Lot number 99767778 Multi-purpose Kit blister tray coupled with Tyvek lid stock heat-sealed to form a sterile barrier.
Terminated
FTNNone listed
Apr 27, 2011Argon Medical Devices, Inc
Argon Medical Devices, Arterial Line Kit, Arterial Catheter Mini Kit, 20GX3in, Part Number 498435, Lot number 99767239 Multi-purpose Kit blister tray coupled with Tyvek lid stock heat-sealed to form
Terminated
FTNNone listed

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