Panels › General, Plastic Surgery › Product code PUI · Class 2
Drape, Surgical, Exempt
Regulation 878.4370
0510(k)s in 12 months (0 all time)
16recalls in 12 months (54 all time)
0recalls that name a 510(k)
Top companies in PUI
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 22, 2026 | Medline Industries, LP MEDLINE medical convenience kits labeled as:
1) HIP SCOPE PACK, Medline Kit Number/SKU DYNJ64103C;
2) HIP SCOPE PACK, Medline Kit Number/SKU DYNJ64155B. Open, Classified |
PUI | None listed |
| Oct 22, 2026 | Medline Industries, LP MEDLINE medical convenience kits labeled as: C-SECTION TRAY-LF, Medline Kit Number/SKU OBN471K Open, Classified |
PUI | None listed |
| Oct 22, 2026 | Medline Industries, LP MEDLINE medical convenience kits labeled as: TUBAL LIGATION RFD, Medline Product Number/SKU DYNJ906291G Open, Classified |
PUI | None listed |
| Oct 22, 2026 | Medline Industries, LP MEDLINE medical convenience kits labeled as:
(list truncated) Open, Classified |
PUI | None listed |
| Oct 22, 2026 | Medline Industries, LP MEDLINE medical convenience kits labeled as:
1) LAPAROTOMY GYN CDS, Medline Kit Number/SKU CDS983529O;
2) GYN ROBOTIC PK-LF, Medline Kit Number/SKU DYNJ52432M;
3) TAH PACK, Medline Kit Number/SKU Open, Classified |
PUI | None listed |
| Oct 22, 2026 | Medline Industries, LP MEDLINE medical convenience kits labeled as:
1) BIRTHDAY KIT-DOUBLE BASIN-LF, Medline Kit Number/SKU DYNJ16127N;
2) NYGH-DELIVERY PACK-LF, Medline Kit Number/SKU DYNJ27206D;
3) OB/GYN, Medline Kit Open, Classified |
PUI | None listed |
| Oct 22, 2026 | Medline Industries, LP MEDLINE medical convenience kits labeled as (list truncated) Open, Classified |
PUI | None listed |
| Oct 22, 2026 | Medline Industries, LP MEDLINE medical convenience kits labeled as: 1) FETAL SURGERY CDS-LF, Medline Kit Number/SKUCDS840214R;
2) MAJOR, Medline Kit Number/SKUDYNJ904851I;
3) ABDOMINAL TRANSPLANT, Medline Kit Number/SKUD Open, Classified |
PUI | None listed |
| Oct 22, 2026 | Medline Industries, LP MEDLINE medical convenience kits labeled as: C-SECTION PACK, Medline Product Number/SKU DYNJ48455A Open, Classified |
PUI | None listed |
| Oct 22, 2026 | Medline Industries, LP MEDLINE medical convenience kits labeled as: FETOSCOPY CDS-LF, Medline Product Number/SKU CDS840215P Open, Classified |
PUI | None listed |
| Oct 22, 2026 | Medline Industries, LP MEDLINE DRAPE C-SECTION FEN CLR SCREEN W, Medline Product Number/SKU DYNJP6108 Open, Classified |
PUI | None listed |
| Oct 22, 2026 | Medline Industries, LP MEDLINE DRAPE C-SEC FEN CLEAR SCRN WIRE, Medline Product Number/SKU DYNJP6106 Open, Classified |
PUI | None listed |
| Oct 22, 2026 | Medline Industries, LP MEDLINE DRAPE C-SECTION W/POUCH ST 7/CS, Medline Product Number/SKU DYNJP6101 Open, Classified |
PUI | None listed |
| May 7, 2026 | Medline Industries, LP Medline Surgical Drapes:
1) SHEET,DRAPE,40X58,STERILE, Model Number: DYNJP2410;
2) DRAPE,SHEET,ECONOMY,40X58",ST,20/CS, Model Number: DYNJP2411;
3) SHEET,DRAPE, 40X70,STERILE, Model Number: DYNJP241 Open, Classified |
PUI | None listed |
| Mar 12, 2026 | Medline Industries, LP Medline Surgical Drapes:
MDTBTCS6070GN DBD-DRAPE,COVER,TABLE,RESIS/XALT GRN,60X
MDTBTCS6090GN DBD-DRAPE,COVER,TABLE,RESIS/XALT GRN,60X
MDTDXUNDBGN DBD-DRAPE,UNDERBUTTOCK,28 X 50.5,XALT GR
MDTMAYOXGN Open, Classified |
PUI | None listed |
| Feb 17, 2026 | Medline Industries, LP Medline Surgical Drapes:
1) SHEET,DRAPE,40X58,STERILE, Model Number: DYNJP2410;
2) DRAPE,SHEET,ECONOMY,40X58",ST,20/CS, Model Number: DYNJP2411;
3) SHEET,DRAPE, 40X70,STERILE, Model Number: DYNJP241 Open, Classified |
PUI | None listed |
| Jun 12, 2025 | Microtek Medical, Inc. Microtek Patient Drape ECOLAB
AP6MMN Patient Drape, 6mm Adapter Plug Kit REF AP6MMN
UDI code: (01)10748426139986
AP8MMN Patient Drape, 8mm Adapter Plug Kit REF AP8MMN
UDI code: (01)10748426139429
T Open, Classified |
PUI | None listed |
| Mar 14, 2025 | MEDLINE INDUSTRIES, LP - Northfield Proxima Drape labeled as DRAPE C-SECTION W/ WINDOW; SHEET, DRAPE, SPLIT, ST,10/CS; DRAPE,LAPROSCOPY,CHOLE,W/TROUGH,ST,8/CS; DRAPE,LAPROSCOPY,CHOLE,W/TROUGH,ST,8/CS; DRAPE,ABDOMINAL,MAJOR,ST,8/CS; DRAP Open, Classified |
PUI | None listed |
| Jul 28, 2023 | Microtek Medical Inc. Equipment and table drapes:
(1) Ecolab Banded Bag with Rubberband and Tape, 91 cm x 51 cm (36 in x 20 in), Model 63620RT, pkgd. 25/case, sterile;
(2) Ecolab Microtek Banded Bag with Elastic Opening, Open, Classified |
PUI | None listed |
| Nov 18, 2022 | 3M Healthcare Business 3M Steri-Drape, Urological Drape, REF 1071, general surgery (urology) drape Open, Classified |
PUI | None listed |
| Nov 18, 2022 | 3M Healthcare Business 3M Steri-Drape, Medium Drape with Incise Film and Pouch, REF 1061NS, general surgery drape Open, Classified |
PUI | None listed |
| Nov 18, 2022 | 3M Healthcare Business 3M Steri-Drape, Medium Drape with Incise Film and Pouch, REF 1061, general surgery drape Open, Classified |
PUI | None listed |
| Nov 18, 2022 | 3M Healthcare Business 3M Steri-Drape, Medium Drape with Incise Film, REF 1060NS, general surgery drape Open, Classified |
PUI | None listed |
| Nov 18, 2022 | 3M Healthcare Business 3M Steri-Drape, Medium Drape with Incise Film, REF 1060, general surgery drape Open, Classified |
PUI | None listed |
| Nov 18, 2022 | 3M Healthcare Business 3M Steri-Drape, Medium Drape with Wide Adhesive Aperture, REF 1033, general surgery drape Open, Classified |
PUI | None listed |
| Nov 18, 2022 | 3M Healthcare Business 3M Steri-Drape, Medium Drape with Adhesive Aperture, REF 1030NS, general surgery drape Open, Classified |
PUI | None listed |
| Nov 18, 2022 | 3M Healthcare Business 3M Steri-Drape, Medium Drape with Adhesive Aperture, REF 1030, general surgery drape Open, Classified |
PUI | None listed |
| Nov 18, 2022 | 3M Healthcare Business 3M Steri-Drape, Small Drape with Incise Film, REF 1021NS, general surgery drape Open, Classified |
PUI | None listed |
| Nov 18, 2022 | 3M Healthcare Business 3M Steri-Drape, Small Drape with Incise Film, REF 1021, general surgery drape Open, Classified |
PUI | None listed |
| Nov 18, 2022 | 3M Healthcare Business 3M Steri-Drape, Small Drape with Adhesive Aperture, REF 1020NS, general surgery drape Open, Classified |
PUI | None listed |
| Nov 18, 2022 | 3M Healthcare Business 3M Steri-Drape, Small Drape with Adhesive Aperture, REF 1020, general surgery drape Open, Classified |
PUI | None listed |
| Nov 18, 2022 | 3M Healthcare Business 3M Steri-Drape, Large Towel Drape, REF 1010NSD, general surgery drape Open, Classified |
PUI | None listed |
| Nov 18, 2022 | 3M Healthcare Business 3M Steri-Drape, Large Towel Drape, REF 1010NS, general surgery drape Open, Classified |
PUI | None listed |
| Nov 18, 2022 | 3M Healthcare Business 3M Steri-Drape, Large Towel Drape, REF 1010, general surgery drape Open, Classified |
PUI | None listed |
| Nov 18, 2022 | 3M Healthcare Business 3M Steri-Drape, Small Towel Drape, REF 1000NSD, general surgery drape Open, Classified |
PUI | None listed |
| Nov 18, 2022 | 3M Healthcare Business 3M Steri-Drape, Small Towel Drape, REF 1000NS, general surgery drape Open, Classified |
PUI | None listed |
| Nov 18, 2022 | 3M Healthcare Business 3M Steri-Drape, Small Towel Drape, REF 1000, general surgery drape Open, Classified |
PUI | None listed |
| Apr 8, 2022 | Microtek Medical Inc. TMJ Arthroscopy Drape, 85''x 96'' Terminated |
PUI | None listed |
| May 21, 2021 | Cardinal Health 200, LLC Nonsterile Femoral Angiography Drape, Catalog Numbers: a) 29460NB, b) 29456NB - Product Usage: intended to be used as protective patient coverings, such as to isolate the site of a surgical incision f Terminated |
PUI | None listed |
| May 21, 2021 | Cardinal Health 200, LLC Sterile Femoral Angiography Drape, Catalog Numbers: a) 29460, b) 29456 - Product Usage: intended to be used as protective patient coverings, such as to isolate the site of a surgical incision from mi Terminated |
PUI | None listed |
| May 21, 2021 | Cardinal Health 200, LLC Nonsterile Sterile Cesarean Birth Drape with Dual Layer Anesthesia Screen, Catalog Number 29442N - Product Usage: intended to be used as protective patient coverings, such as to isolate the site of a Terminated |
PUI | None listed |
| May 21, 2021 | Cardinal Health 200, LLC Sterile Cesarean Birth Drape with Dual Layer Anesthesia Screen, Catalog Number 29442 - Product Usage: intended to be used as protective patient coverings, such as to isolate the site of a surgical inc Terminated |
PUI | None listed |
| May 21, 2021 | Cardinal Health 200, LLC Nonsterile Radial/Femoral Angiography Drape, Catalog Number 29529N - Product Usage: intended to be used as protective patient coverings, such as to isolate the site of a surgical incision from microbi Terminated |
PUI | None listed |
| May 21, 2021 | Cardinal Health 200, LLC Sterile Radial/Femoral Angiography Drape, Catalog Number 29529 - Product Usage: intended to be used as protective patient coverings, such as to isolate the site of a surgical incision from microbial a Terminated |
PUI | None listed |
| May 21, 2021 | Cardinal Health 200, LLC Nonsterile Femoral Angiography Drape with Single Pouch, Catalog Number 29525N - Product Usage: intended to be used as protective patient coverings, such as to isolate the site of a surgical incision f Terminated |
PUI | None listed |
| May 21, 2021 | Cardinal Health 200, LLC Sterile Femoral Angiography Drape with Single Pouch, Catalog Number 29525 - Product Usage: intended to be used as protective patient coverings, such as to isolate the site of a surgical incision from Terminated |
PUI | None listed |
| Feb 25, 2021 | Cardinal Health 200, LLC Femoral Angiography Drape Bulk Non-Sterile Terminated |
PUI | None listed |
| Feb 25, 2021 | Cardinal Health 200, LLC Femoral Angiography Drape Sterile Terminated |
PUI | None listed |
| Jan 11, 2021 | Ecolab Inc Slush + Warmer Disc Drape; Model ORS-320 Slush + Warmer Disc Drapes - Product Usage: single-use equipment cover intended for use during various surgeries where warm irrigation, slush and/or cold solut Terminated |
PUI | None listed |
| Oct 1, 2019 | Aesculap Implant Systems LLC Aesculap Sterile disposable fleece drape, Product code: GA414, individually packaged, 50 pieces per shipping unit, product code SZ380R. Terminated |
PUI | None listed |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.