NEW
QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN
- Advisory panel
- General, Plastic Surgery
- Total cleared
- 62
Adverse events under product code NEW
product code NEW- Death
- 32
- Injury
- 2,179
- Malfunction
- 8,975
- Total
- 11,186
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code NEW
- K243897 — PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture
- K251414 — Miracu Polydioxanone (PDO) Suture and Needle (MONO)
- K250107 — V-soft Line Barbed Surgical Suture (Various)
- K252644 — PINION PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; PINION PGA-PCL Knotless Suture - Absorbable Poly (Glycolide-Co-Caprolactone) Knotless Suture
- K250977 — Suture-TOOL System
- K242835 — Suture-TOOL System
- K242571 — Secret Line up (FC1938E80 FC1950E90 FC1960E100 FC1970E120 FC1990E150 FC19100E150 FC19100E280 FC19100E420 FC2038E80 FC2050E90 FC2060E100 FC2070E120 FC2090E150 FC20100E170 FC2138G80 FC2150G90 FC2160G100 FC2170G120 FC2190G150 FC21100G170 FCL18100C160 FCL1938E80 FCL1950E90 FCL1960E100 FCL1970E120 FCL1990E150 FCL19100E160 FCL2138G80 FCL2150G90 FCL2160G100 FCL2170G120 FCL2190G150 FCL21100G160 FCRL1870C162 FCRL18100C185 FCRL1970E162 FCRL19100E185 FCHL1960E90 FCHL1970E120 FCHL19100E160 FCW1938
- K232246 — 1) PINION PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; 2) PINION PGA-PCL Knotless Suture - Absorbable Polyglycolic Acid - Poly (Glycolide-Co-Caprolactone) Knotless Suture
- K240389 — Secret Line up (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150 ); i-Thread (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150)
- K220549 — MINT Product Family (Including MINT, MINT Lift, and MINT-I Sutures), MINT Lift ML 1043, MINT Lift ML 1013, MINT Lift 1019, MINT Lift Mini 1014
- K212380 — PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical Suture
- K210871 — PDO Max Suture with Dual Needle
- K201139 — WEGO-PDO Barbed Suture
- K192423 — MINT Product Family
- K192144 — STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device
- K191361 — DemeDIOX Barbed Absorbable Surgical Suture
- K190264 — Viola
- K190245 — PDS Barbed Suture, PDO MAXX Threads
- K182873 — STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Knotless Tissue Control Devices
- K172602 — Miracu
- K181582 — DemeTECH DemeDIOX absorbable surgical suture
- K162366 — Omega VL
- K161737 — RELI REDIDIOX Dyed, RELI REDIDIOX, RELI REDIDIOX Undyed
- K160705 — Y.JACOBS YOUNG'S THREAD Synthetic Absorbable Surgical Fixation Suture,
- K160761 — DW-1C
- K150553 — Filbloc
- K143413 — J+PRAS YOUNG'S Thread
- K150670 — STRATAFIX Spiral PDS Plus Knotless Tissue Control Device
- K141776 — STRATAFIX SYMMETRIC PDS PLUS KNOTLESS TISSUE CONTROL DEVICES
- K133420 — TRANQUILL BARBED DEVICE
- K132268 — QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN
- K130191 — MINT
- K123668 — ORTHOCORD
- K123877 — QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN
- K120827 — QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE (POLYDIXANONE)
- K120284 — DIGITEX SUTURE DELIVERY SYSTEM, DIGITEXPOLYPROPYLENE SUTURE CARTRIDGE SIZE 0, WITH NEEDLE AND WITHOUT NEEDLE, DIGITEX
- K113744 — QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE (POLYDIOXANONE)
- K113004 — PDS(TM) BARBED SUTURES
- K100780 — VITAL SUTURES, SUTUREX, CIRUGIA PERUANA
- K100461 — PDM, VILET, VILET QUICK, MONO Q, PLAIN GUT:# 6 CHROMIC GUT
- K082097 — DEMETECH POLYDIOXANONE SYNTHETIC MONOFILAMENT (PDO) ABSORBABLE SUTURE
- K081001 — PD SYNTH, ABSORBABLE (POLY DIOXANONE) SUTURE
- K073614 — WG-SURGICAL SUTURES WITH NEEDLE
- K080918 — DOUBLE ARMED MENISCAL NEEDLES WITH SIZE #2-0 ORTHOCORD, MENISCAL NEEDLE WITH WIRE EYELET & 3 FREE STRANDS OF SIZE #2-0
- K080985 — QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF POLYDIOXANONE (PDO)
- K080680 — QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF PDO (POLYDIOXANONE
- K071989 — QUILL SELF-RETAINING SYSTEM (SRS) SYNTHETIC ABSORBABLE SURGICAL SUTURE MATERIAL
- K063680 — SHARPOINT PDO (POLYDIOXANONE) SUTURES
- K061037 — PDS PLUS ANTIBACTERIAL SUTURE
- K053380 — CONTOUR THREAD SYNTHETIC ABSORBABLE PDO BARBED SUTURE
- K051609 — QUILL SYNTHETIC ABSORBABLE BARBED SUTURE
- K042285 — UNICRYL M
- K043298 — BLUE ORTHOCORD SUTURE
- K042075 — QUILL SYNTHETIC ABSORBABLE BARBED SUTURE
- K041048 — POLYDIOXANONE SYNTHETIC ABSORBABLE SURGICAL SUTURE
- K040004 — ORTHOCORD SUTURE
- K031216 — MONOPLUS POLY-P-DIOXANONE MONOFILAMENT ABSORBABLE SURGICAL SUTURE
- K031443 — LSI SOLUTIONS SUTURE QUICK LOAD PRODUCTS
- K030786 — MONO-SWIFT
- K030212 — MONODEK SYNTHETIC ABSORBABLE SURGICAL SUTURE
- K022666 — PDO (POLYDIOXANONE) MONOFILAMENT SYNTHETIC ABSORBABLE SUTURE U.S.P.
- K013274 — MONO-DOX, SYNTHETIC ABSORBABLE POLYDIOXANONE SURGICAL SUTURE,STERILE
Data sourced from openFDA. This site is unofficial and independent of the FDA.