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)
Top companies in FTN
| Company | 510(k)s | Recalls |
|---|---|---|
| Argon Medical Devices, Inc | 0 | 19 |
| MEDLINE INDUSTRIES, LP - Northfield | 0 | 16 |
| Medline Industries, LP | 0 | 15 |
| Stradis Medical, LLC dba Stradis Healthcare | 0 | 6 |
| American Contract Systems | 0 | 4 |
| Mentor Texas, Inc | 0 | 1 |
| ROi CPS LLC | 0 | 1 |
| SRI Surgical | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 31, 2026 | Medline Industries, LP Medline Convenience Kits:
1) ULTRASOUND BREAST PACK, Model Number: DYNJ63375C Open, Classified |
FTN | None listed |
| Aug 26, 2026 | Medline Industries, LP Medline convenience kits labeled as: LTP CDS-LF, Medline kit SKU CDS980375M Open, Classified |
FTN | None listed |
| Jun 25, 2026 | Medline 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 |
FTN | None listed |
| Jun 17, 2026 | Medline 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 |
FTN | None listed |
| Jun 12, 2026 | Medline 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 |
FTN | None listed |
| May 7, 2026 | Medline 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 |
FTN | None listed |
| Apr 30, 2026 | Medline Industries, LP Medline medical procedure kits, containing Medline Neuro Sponges (102 in total) Open, Classified |
FTN | None listed |
| Apr 17, 2026 | Medline Industries, LP Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes
FACE/RHINOPLASTY PACK DYNJ80343C
PLASTIC HEAD-NECK PACK DYNJ86639 Open, Classified |
FTN | None listed |
| Apr 17, 2026 | Medline Industries, LP Medline Kits:
1) BREAST PACK, Model Number: DYNJ66777D Open, Classified |
FTN | 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:
MINOR PLASTIC-LF, Medline Kit SKU # DYNJ86596 Open, Classified |
FTN | None listed |
| Feb 17, 2026 | Medline 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 |
FTN | None listed |
| Jan 28, 2026 | Medline 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 |
FTN | None listed |
| Jan 12, 2026 | Medline 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 |
FTN | None listed |
| Nov 14, 2025 | Medline 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 |
FTN | None listed |
| Nov 13, 2025 | Medline Industries, LP Convenience Kit, BREAST HERNIA
DYNJ909125G Open, Classified |
FTN | None listed |
| Apr 17, 2025 | MEDLINE 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 |
FTN | None listed |
| Mar 26, 2025 | MEDLINE 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 |
FTN | None listed |
| Mar 14, 2025 | MEDLINE INDUSTRIES, LP - Northfield Proxima Drape labeled as FACE LIFT. Sterile surgical drape. Open, Classified |
FTN | None listed |
| Dec 30, 2024 | MEDLINE 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 |
FTN | None listed |
| Dec 20, 2024 | MEDLINE INDUSTRIES, LP - Northfield SEPTOPLASTY PACK Convenient kit, SKU DYNJ44759F.
Convenience kits used for various procedures. Open, Classified |
FTN | None listed |
| Dec 5, 2024 | MEDLINE 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 |
FTN | None listed |
| Oct 23, 2024 | MEDLINE 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 |
FTN | None listed |
| Sep 11, 2024 | MEDLINE 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 |
FTN | None listed |
| Sep 6, 2024 | MEDLINE 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 |
FTN | None listed |
| Aug 28, 2024 | MEDLINE 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 |
FTN | None listed |
| Aug 22, 2024 | MEDLINE 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 |
FTN | None listed |
| Feb 25, 2024 | MEDLINE 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 |
FTN | None listed |
| Jan 26, 2024 | American 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 |
FTN | None listed |
| Oct 26, 2023 | American Contract Systems, Inc. Breast Plastics Pack, REF BBPL20D Open, Classified |
FTN | None listed |
| Aug 3, 2023 | MEDLINE 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 |
FTN | None listed |
| Jul 20, 2023 | MEDLINE 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 |
FTN | None listed |
| Feb 10, 2023 | MEDLINE INDUSTRIES, LP - Northfield Surgical convenience kits labeled as: MEDLINE PLASTICS/PEDS KIT, Reorder Number DYNDA2489 Open, Classified |
FTN | None listed |
| Feb 6, 2023 | MEDLINE 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 |
FTN | None listed |
| Dec 14, 2022 | Stradis Medical, LLC dba Stradis Healthcare STRADIS HEALTHCARE, Breast, Item No.693-276, Open, Classified |
FTN | None listed |
| Dec 14, 2022 | Stradis Medical, LLC dba Stradis Healthcare STRADIS HEALTHCARE, Thoracic Phleb, Item No.682-1228, Open, Classified |
FTN | None listed |
| Dec 14, 2022 | Stradis Medical, LLC dba Stradis Healthcare STRADIS HEALTHCARE, Lipo, Item No.681-254, Open, Classified |
FTN | None listed |
| Dec 14, 2022 | Stradis Medical, LLC dba Stradis Healthcare HENRY SCHEIN, RHINO PACK, Item No.570-3070 Open, Classified |
FTN | None listed |
| Dec 14, 2022 | Stradis Medical, LLC dba Stradis Healthcare HENRY SCHEIN, BREAST PACK, Item No.570-2397 Open, Classified |
FTN | None listed |
| Dec 14, 2022 | Stradis Medical, LLC dba Stradis Healthcare HENRY SCHEIN, Breast Augmentation tray, Item No.570-0611 Open, Classified |
FTN | None listed |
| Jun 16, 2022 | American Contract Systems, Inc. Breast Abdominoplasty Pack Open, Classified |
FTN | None listed |
| Apr 20, 2020 | ROi CPS LLC Regard. Item number: 830034. GS0348D- CVC Triple Lumen 20CM non Sulfa-Mercy. Terminated |
FTN | None listed |
| Apr 13, 2020 | American Contract Systems Sterile Custom Packs to be used in surgical procedures. Terminated |
FTN | None listed |
| Aug 29, 2012 | SRI 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 |
FTN | None listed |
| Apr 27, 2011 | Argon 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 |
FTN | None listed |
| Apr 27, 2011 | Argon 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 |
FTN | None listed |
| Apr 27, 2011 | Argon 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 |
FTN | None listed |
| Apr 27, 2011 | Argon 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 |
FTN | None listed |
| Apr 27, 2011 | Argon 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 |
FTN | None listed |
| Apr 27, 2011 | Argon 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 |
FTN | None listed |
| Apr 27, 2011 | Argon 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 |
FTN | None listed |
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