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

Retractor

Regulation 878.4800

0510(k)s in 12 months (100 all time)
1recalls in 12 months (44 all time)
1recalls that name a 510(k)
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Top companies in GAD

DateFirm and productCodeLinked 510(k)
Jul 9, 2026Integra LifeSciences Corp. (NeuroSciences)
OmniTract Surgical Retractor System, which includes 633 of the firm s product codes.
Open, Classified
GADNone listed
May 15, 2025MEDLINE INDUSTRIES, LP - Northfield
Centurion Sterile Weitlaner Retractor, Reorder: 67315
Open, Classified
GADNone listed
Jan 16, 2025Sklar Instruments
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE ARMY RETR (SET OF 2) STER CS25, Model Number 96-2243; 2) ECONO STERILE ARMY RETR (SET OF 2)STRL CS/25, Model Number 96-2243M; 3) E
Open, Classified
GADNone listed
Jun 28, 2024SEASPINE ORTHOPEDICS CORPORATION
Brand Name: Fathom Pedicle-Based Retractor Product Name: C/C Blade, 50-80mm Model/Catalog Number: MR2102050 Product Description: Cranial Caudal Blade Component: Yes, a component of a retractor blade
Open, Classified
GADNone listed
Jun 28, 2024SEASPINE ORTHOPEDICS CORPORATION
Brand Name: Fathom Pedicle-Based Retractor Product Name: C/C Blade, 35-55mm Model/Catalog Number: MR2102035 Product Description: Cranial Caudal Blade Component: Yes, a component of a retractor blade
Open, Classified
GADNone listed
Mar 29, 2024MEDLINE INDUSTRIES, LP - Northfield
Centurion retractor kits labeled as: a) STERILE 6-1/2" SENN RETRACTOR (ST7185), Product Code 66795; b) STERILE RAGNELL RETRACTOR (RR602), Product Code 67525; c) ST. SENN RETRACTOR 3 PRG BLUNT (ST708
Open, Classified
GADNone listed
Feb 23, 2024Medagent Inc
Rebstock Holding rod for fixation -For holding and fixation of flexible Leyla Arms and spatula Art. No. 06-06-285 and 06-06-285MOD. surgical instrument.
Open, Classified
GADNone listed
Jul 5, 2023TELEFLEX LLC
Pilling LOWSLEY PROSTATIC TRACTOR STR, REF 243201; retractor
Open, Classified
GADNone listed
Jul 5, 2023TELEFLEX LLC
Pilling LOWSLEY PROSTATIC TRACTOR CVD, REF 243200; retractor
Open, Classified
GADNone listed
Jan 12, 2023Medtronic Navigation, Inc.
RadiaLux Lighted Retractor (Pink), REF: 50-101-1
Open, Classified
GADNone listed
Aug 3, 2020Smith & Nephew, Inc.
Single RIKKI Retractor, Catalog #71934609 - Product Usage: is used during surgery to hold soft tissue away from the surgical site.
Terminated
GADNone listed
Nov 28, 2019AAP Implantate Ag
aap Implantate AG, Soft tissue retractor, radiolucent, REF IU 7971-00
Terminated
GADNone listed
Sep 4, 2018CooperSurgical, Inc.
Retractor System Elastic Stays (Part 3314-lG; 3316-lG; 3550-lG) Product Usage: The Retractor System Elastic Stays (Part 3314-lG; 3316-lG; 3550-lG) are a sterile single-use medical device providing re
Terminated
GADK791665
Apr 2, 2018Synthes (USA) Products LLC
Retractor f/Sciatic Nerve Long; Part number: 03.100.014; UDI: 10886982070630
Terminated
GADNone listed
Apr 2, 2018Synthes (USA) Products LLC
Retractor f/Sciatic Nerve; Part number: 03.100.013; UDI: 10886982070623
Terminated
GADNone listed
Mar 10, 2016Biomet, Inc.
Verso Shoulder Forked Retractor (Comprehensive Instrumentation 2 Prong Retractor) Biomet Comprehensive Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly de
Terminated
GADNone listed
Feb 17, 2016Applied Medical Technology Inc
Wilson Implantation System Product Usage: Indicated to aid in tissue retraction during a surgical procedure.
Terminated
GADNone listed
Feb 17, 2016Applied Medical Technology Inc
Wilson Penile Implantation System Retractor Frame, Retractor Stays & Penile Elevation Strap, SINGLE USE ONLY Rx ONLY (USA) STERILE EO Do Not Resterilize Product Usage: Indicated to aid in tissue retr
Terminated
GADNone listed
Feb 17, 2016Applied Medical Technology Inc
TLC Self-Retaining Retractor Frames SINGLE USE ONLY Rx ONLY (USA) STERILE EO Do Not Resterilize. Product Usage: Indicated to aid in tissue retraction during a surgical procedure.
Terminated
GADNone listed
Feb 17, 2016Applied Medical Technology Inc
TLC Self Retaining Retractor System Contents 1-RETRACTOR FRAME 6-ELASTIC STAYS STERILE EO Rx ONLY Product Usage: Indicated to aid in tissue retraction during a surgical procedure.
Terminated
GADNone listed
Nov 17, 2015Aesculap, Inc.
Valve XS Atrium Retractor FC429R 52154756 The Valve XS Atrium Lift Retractor is used in heart surgery. The retractor is used for the temporary dilation of the left atrium in mitral valve surgery and
Terminated
GADNone listed
Aug 19, 2015Synthes (USA) Products LLC
Synthes Sciatic Nerve Retractor and Sciatic Nerve Retractor Long; Synthes Sciatic Nerve Retractor and Sciatic Nerve Retractor Long are system specific instruments to the 3.5 mm Low Profile Pelvic Syst
Terminated
GADNone listed
Jan 14, 2015Synthes, Inc.
Malleable C- Retractor, Part Number 397.232, used to provide retraction of the soft tissues during use of trocar instrumentation. Used in the following systems: the Basic Trocar System, Universal Tro
Terminated
GADNone listed
Oct 20, 2014Synthes, Inc.
DePuy Synthes Radiolucent Retractor, part number 387.580, lot number 3620715
Terminated
GADNone listed
Apr 15, 2014Synthes, Inc.
The Synthes Hohmann Retractor, 43 mm Long Shank, Angled 235 mm Product Usage: Used to expose bone for procedures.
Terminated
GADNone listed
Nov 29, 2013Synthes USA HQ, Inc.
Synthes Soft Tissue Retractor Small Extendible. Offset blade facilitates easy preparation of the epipereosteal cavity for percutaneous plate insertion.
Terminated
GADNone listed
Nov 18, 2013Synthes USA HQ, Inc.
Synthes Soft Tissue Retractor Small Extendible Offset blade facilitates easy preparation of the epipereosteal cavity for percutaneous plate insertion.
Terminated
GADNone listed
Oct 21, 2013Aesculap, Inc.
UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.
Terminated
GADNone listed
Jul 22, 2013Pemco Inc
Rultract Retractor Ratchet Cover Plate Distributed by Pemco, Inc., Cleveland, OH 44131 Surgical retractor used to lift the incision site
Terminated
GADNone listed
Aug 7, 2012Stryker Spine
LUXOR RETRACTOR BASE; Catalog Number: 48250030; Manufactured by: STRYKER Spine SAS; Z.I MARTICOT-33610-CESTAS-FRANCE; Distributed in the USA by: Stryker Spine. 2 Pearl Ct. Allendale, NJ 07401. Provid
Terminated
GADNone listed
Dec 11, 2009Alphatec Spine, Inc.
ILLICO Posterior Thoracolumbar Access Retractor, Part Number: 73520 The ILLICO Posterior Thoracolumbar Access Retractor is an instrument that is intended for use in a minimally invasive approach for
Terminated
GADNone listed
Jan 13, 2009Sterilmed Inc
Retractors Model #'s: ADE3204 BOS820-175 LON3304 and LON3334-4G A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either resusable or disposable, i
Terminated
GADNone listed
Dec 27, 2006Whiteside Biomechanics
Posterior Acetabular Retractor-Left with Light Cord Bracket, Model #BIO-1-1050-A, and Posterior Acetabular Retractor-Right with Light Cord Bracket, Model #BIO-1-1051-A, packaged 1 retractor (left or r
Terminated
GADNone listed
Nov 28, 2006Lone Star Medical Products, Inc
Lone Star Medical Products, Inc. 1100 Series Aluminum Retractor Rings, model #1110; manufactured by Lone Star Medical Products, Inc.
Terminated
GADNone listed
Nov 28, 2006Lone Star Medical Products, Inc
Lone Star Medical Products, Inc. 1100 Series Aluminum Retractor Rings, Model #1107; manufactured by Lone Star Medical Products, Inc.
Terminated
GADNone listed
Nov 28, 2006Lone Star Medical Products, Inc
Lone Star Medical Products, Inc. 1100 Series Aluminum Retractor Rings, Model #1104; manufactured by Lone Star Medical Products, Inc.
Terminated
GADNone listed
Dec 1, 2005Boston Scientific Corporation
Precision Tack Transvaginal Sling Kit with Non-Absorbable, Braided Polyester Suture (contains 1 Product Code 820-175) Product Code: 820-123
Terminated
GADNone listed
Dec 1, 2005Boston Scientific Corporation
Precision Tack Transvaginal Sling Kit with Non-Absorbable, Polybustester Monofilament Suture (contains 1 Product Code 820-175) Product Code: 820-124
Terminated
GADNone listed
Dec 1, 2005Boston Scientific Corporation
Capio CL Kit Transvaginal Suture Capturing Device (1TLC Retractor box ) Product Code: 831-130
Terminated
GADNone listed
Dec 1, 2005Boston Scientific Corporation
Precision Tack Transvaginal Sling Kit with Non-Absorbable, Braided Polyester Suture (contains 1 Product Code 820-175) Product Code: 820-171
Terminated
GADNone listed
Dec 1, 2005Boston Scientific Corporation
Precision Twist Transvaginal Sling Kit with Non-Absorbable, Polybutester Monofilament Suture (contains 1 Product Code 820-175) Product Code: 820-172
Terminated
GADNone listed
Dec 1, 2005Boston Scientific Corporation
TLC Retractor and Single Step Pelvic Drape (contains 1 Product Code 820-175) Product Code: 820-177
Terminated
GADNone listed
Dec 1, 2005Boston Scientific Corporation
TLC Self -Retaining Retractor System-5/box Product Number:820-176
Terminated
GADNone listed
Dec 1, 2005Boston Scientific Corporation
TLC Self -Retaining Retractor System-Single Product Code: 820-175
Terminated
GADNone listed

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