ClearanceBrief
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)
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Top companies in PUI

DateFirm and productCodeLinked 510(k)
Oct 22, 2026Medline 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
PUINone listed
Oct 22, 2026Medline Industries, LP
MEDLINE medical convenience kits labeled as: C-SECTION TRAY-LF, Medline Kit Number/SKU OBN471K
Open, Classified
PUINone listed
Oct 22, 2026Medline Industries, LP
MEDLINE medical convenience kits labeled as: TUBAL LIGATION RFD, Medline Product Number/SKU DYNJ906291G
Open, Classified
PUINone listed
Oct 22, 2026Medline Industries, LP
MEDLINE medical convenience kits labeled as: (list truncated)
Open, Classified
PUINone listed
Oct 22, 2026Medline 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
PUINone listed
Oct 22, 2026Medline 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
PUINone listed
Oct 22, 2026Medline Industries, LP
MEDLINE medical convenience kits labeled as (list truncated)
Open, Classified
PUINone listed
Oct 22, 2026Medline 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
PUINone listed
Oct 22, 2026Medline Industries, LP
MEDLINE medical convenience kits labeled as: C-SECTION PACK, Medline Product Number/SKU DYNJ48455A
Open, Classified
PUINone listed
Oct 22, 2026Medline Industries, LP
MEDLINE medical convenience kits labeled as: FETOSCOPY CDS-LF, Medline Product Number/SKU CDS840215P
Open, Classified
PUINone listed
Oct 22, 2026Medline Industries, LP
MEDLINE DRAPE C-SECTION FEN CLR SCREEN W, Medline Product Number/SKU DYNJP6108
Open, Classified
PUINone listed
Oct 22, 2026Medline Industries, LP
MEDLINE DRAPE C-SEC FEN CLEAR SCRN WIRE, Medline Product Number/SKU DYNJP6106
Open, Classified
PUINone listed
Oct 22, 2026Medline Industries, LP
MEDLINE DRAPE C-SECTION W/POUCH ST 7/CS, Medline Product Number/SKU DYNJP6101
Open, Classified
PUINone listed
May 7, 2026Medline 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
PUINone listed
Mar 12, 2026Medline 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
PUINone listed
Feb 17, 2026Medline 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
PUINone listed
Jun 12, 2025Microtek 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
PUINone listed
Mar 14, 2025MEDLINE 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
PUINone listed
Jul 28, 2023Microtek 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
PUINone listed
Nov 18, 20223M Healthcare Business
3M Steri-Drape, Urological Drape, REF 1071, general surgery (urology) drape
Open, Classified
PUINone listed
Nov 18, 20223M Healthcare Business
3M Steri-Drape, Medium Drape with Incise Film and Pouch, REF 1061NS, general surgery drape
Open, Classified
PUINone listed
Nov 18, 20223M Healthcare Business
3M Steri-Drape, Medium Drape with Incise Film and Pouch, REF 1061, general surgery drape
Open, Classified
PUINone listed
Nov 18, 20223M Healthcare Business
3M Steri-Drape, Medium Drape with Incise Film, REF 1060NS, general surgery drape
Open, Classified
PUINone listed
Nov 18, 20223M Healthcare Business
3M Steri-Drape, Medium Drape with Incise Film, REF 1060, general surgery drape
Open, Classified
PUINone listed
Nov 18, 20223M Healthcare Business
3M Steri-Drape, Medium Drape with Wide Adhesive Aperture, REF 1033, general surgery drape
Open, Classified
PUINone listed
Nov 18, 20223M Healthcare Business
3M Steri-Drape, Medium Drape with Adhesive Aperture, REF 1030NS, general surgery drape
Open, Classified
PUINone listed
Nov 18, 20223M Healthcare Business
3M Steri-Drape, Medium Drape with Adhesive Aperture, REF 1030, general surgery drape
Open, Classified
PUINone listed
Nov 18, 20223M Healthcare Business
3M Steri-Drape, Small Drape with Incise Film, REF 1021NS, general surgery drape
Open, Classified
PUINone listed
Nov 18, 20223M Healthcare Business
3M Steri-Drape, Small Drape with Incise Film, REF 1021, general surgery drape
Open, Classified
PUINone listed
Nov 18, 20223M Healthcare Business
3M Steri-Drape, Small Drape with Adhesive Aperture, REF 1020NS, general surgery drape
Open, Classified
PUINone listed
Nov 18, 20223M Healthcare Business
3M Steri-Drape, Small Drape with Adhesive Aperture, REF 1020, general surgery drape
Open, Classified
PUINone listed
Nov 18, 20223M Healthcare Business
3M Steri-Drape, Large Towel Drape, REF 1010NSD, general surgery drape
Open, Classified
PUINone listed
Nov 18, 20223M Healthcare Business
3M Steri-Drape, Large Towel Drape, REF 1010NS, general surgery drape
Open, Classified
PUINone listed
Nov 18, 20223M Healthcare Business
3M Steri-Drape, Large Towel Drape, REF 1010, general surgery drape
Open, Classified
PUINone listed
Nov 18, 20223M Healthcare Business
3M Steri-Drape, Small Towel Drape, REF 1000NSD, general surgery drape
Open, Classified
PUINone listed
Nov 18, 20223M Healthcare Business
3M Steri-Drape, Small Towel Drape, REF 1000NS, general surgery drape
Open, Classified
PUINone listed
Nov 18, 20223M Healthcare Business
3M Steri-Drape, Small Towel Drape, REF 1000, general surgery drape
Open, Classified
PUINone listed
Apr 8, 2022Microtek Medical Inc.
TMJ Arthroscopy Drape, 85''x 96''
Terminated
PUINone listed
May 21, 2021Cardinal 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
PUINone listed
May 21, 2021Cardinal 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
PUINone listed
May 21, 2021Cardinal 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
PUINone listed
May 21, 2021Cardinal 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
PUINone listed
May 21, 2021Cardinal 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
PUINone listed
May 21, 2021Cardinal 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
PUINone listed
May 21, 2021Cardinal 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
PUINone listed
May 21, 2021Cardinal 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
PUINone listed
Feb 25, 2021Cardinal Health 200, LLC
Femoral Angiography Drape Bulk Non-Sterile
Terminated
PUINone listed
Feb 25, 2021Cardinal Health 200, LLC
Femoral Angiography Drape Sterile
Terminated
PUINone listed
Jan 11, 2021Ecolab 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
PUINone listed
Oct 1, 2019Aesculap Implant Systems LLC
Aesculap Sterile disposable fleece drape, Product code: GA414, individually packaged, 50 pieces per shipping unit, product code SZ380R.
Terminated
PUINone listed

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