ClearanceBrief
Panels › General, Plastic Surgery › Product code LMF · Class 3

Agent, Absorbable Hemostatic, Collagen Based

Regulation 878.4490

0510(k)s in 12 months (0 all time)
1recalls in 12 months (27 all time)
0recalls that name a 510(k)
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Top companies in LMF

DateFirm and productCodeLinked 510(k)
Apr 21, 2026Davol, Inc.
Avitene Ultrafoam Microfibrillar Collagen Hemostat - 8cm x 6.25cm x 1cm. Catalog Number: 1050030.
Open, Classified
LMFNone listed
May 22, 2024Ethicon, Inc.
SURGIFOAM" Absorbable Gelatin Powder Kit, Product Code 1979.
Open, Classified
LMFNone listed
Jan 5, 2024Baxter Healthcare Corporation
Baxter FloSeal Hemostatic Matrix RECOTHROM, Product Codes: a) ADS202105, 5mL-6 PK US b) ADS202110, 10mL US
Open, Classified
LMFNone listed
Jan 5, 2024Baxter Healthcare Corporation
Baxter Floseal Hemostatic Matrix Fast Prep, Product Codes: a) ADS201844, 5 mL b) ADS201845, 10mL
Open, Classified
LMFNone listed
Aug 26, 2022Mckesson Medical-Surgical Inc. Corporate Office
Ethicon SURGIFLO Hemostatic Matrix Kit with Thrombin (6/CS) Ref: 2994 Mfg: FERROSAN MEDICAL DEVICES A/S Indicated in surgical procedures (other than ophthalmic) as an adjunct to hemostasis when
Open, Classified
LMFNone listed
May 10, 2013Integra LifeSciences Corporation
Absorbable Collagen Sponge Provided As Intermediate to Another Company
Terminated
LMFNone listed
May 10, 2013Integra LifeSciences Corporation
Helitene Absorbable Collagen Hemostatic Sponge Helitene is indicated in surgical procedures (other than ophthalmological and urological surgery) as an adjunct to hemostasis when control of bleeding b
Terminated
LMFNone listed
May 10, 2013Integra LifeSciences Corporation
Helistat Absorbable Hemostatic,Collagen Based Helistat is indicated in surgical procedures (other than ophthalmological and urological surgery) as an adjunct to hemostasis when control of bleeding by
Terminated
LMFNone listed
May 10, 2013Integra LifeSciences Corporation
INSTAT - Agent, Absorbable Hemostatic, Collagen Based INSTAT MCH is recommended for use in surgical procedures (other than Urological and Ophthalmological surgery) as an adjunct to hemostatis when co
Terminated
LMFNone listed
Nov 22, 2012Stryker Orthobiologics, Inc.
Styker Orthobiologics Vita Plasma Separator, a component of Vitagel Surgical Hemostat. Sterile, single use device designed to prepare plasma from the patient's blood using a tabletop centrifuge.
Terminated
LMFNone listed
Nov 16, 2012Superstat Corp
Superstat Modified Collagen Hemostatic Sponge, 50mm Disc, 3.0%, Part# 9200-30. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and aroun
Terminated
LMFNone listed
Nov 16, 2012Superstat Corp
Superstat Modified Collagen Hemostatic Sponge, 32mm Disc, 3.0%, Part# 9100-30. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and aroun
Terminated
LMFNone listed
Nov 16, 2012Superstat Corp
Superstat Modified Collagen Hemostatic Sponge, 7.5mm x 19mm Cone, 3.0%, Part# 9015-30, 9003-30. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, disse
Terminated
LMFNone listed
Nov 16, 2012Superstat Corp
Superstat Modified Collagen Hemostatic Sponge, 85mm x 85mm Pledget, 1.5%, Part# 9300-15. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections,
Terminated
LMFNone listed
Nov 16, 2012Superstat Corp
Superstat Modified Collagen Hemostatic Sponge, 32mm Disc, 1.5%, Part# 9120-15, 9100-15. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections,
Terminated
LMFNone listed
Nov 16, 2012Superstat Corp
Superstat Modified Collagen Hemostatic Sponge, 4x4 Pledget, 3.0%, Part# 9102-00. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and aro
Terminated
LMFNone listed
Nov 16, 2012Superstat Corp
Superstat Modified Collagen Hemostatic Sponge, 2x2 Pledget, 3.0%, Part# 9106-00. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and ar
Terminated
LMFNone listed
Nov 16, 2012Superstat Corp
Superstat Modified Collagen Hemostatic Sponge, 2x2 Pledget, 1.5%, Part# 9105-00. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and aro
Terminated
LMFNone listed
Nov 16, 2012Superstat Corp
Superstat Modified Collagen Hemostatic Sponge, 85mm x 85mm Pledget, 3.0%, Part# 9300-30. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections
Terminated
LMFNone listed
Nov 16, 2012Superstat Corp
Superstat Modified Collagen Hemostatic Sponge, 50mm Disc, 3.0%, Part# 9200-30. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and aroun
Terminated
LMFNone listed
Nov 16, 2012Superstat Corp
Superstat Modified Collagen Hemostatic Sponge, 115mm x 115mm Pledget, 3.0%, Part# 9500-30. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissection
Terminated
LMFNone listed
Nov 16, 2012Superstat Corp
Superstat Modified Collagen Hemostatic Sponge, 50mm Disc, 1.5%, Part# 9200-15. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and aroun
Terminated
LMFNone listed
Nov 16, 2012Superstat Corp
Superstat Modified Collagen Hemostatic Sponge.115mmx115mm Pledget, 1.5%, Part#9500-15. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections,
Terminated
LMFNone listed
Nov 16, 2012Ethicon, Inc.
ETHICON SURGIFLO HEMOSTATIC MATRIX Distributed by ETHICON ETHICON, Inc. Somerville, NJ 08876, USA SURGIFLO Hemostatic Matrix is a topical absorbable hemostat consisting of a flowable gelatin matrix
Terminated
LMFNone listed
Nov 16, 2012Ethicon, Inc.
ETHICON SURGIFLO HEMOSTATIC MATRIX KIT Plus FlexTip with Thrombin distributed by ETHICON ETHICON Inc. Somerville, NJ 08876 USA Ref 2993 SURGIFLO Hemostatic Matrix, mixed with sterile saline or
Terminated
LMFNone listed
Jun 27, 2012Ethicon, Inc.
Ethicon Surgiflo Hemostatic Matrix Kit with Thrombin Plus Flex Tip Distributed by Ethicon Ethicon Inc., Somerville, NJ 08876 USA Manufactured by Ferrosan Medical Devices Ferrosan Medical Devices A/S
Terminated
LMFNone listed
Sep 20, 2008Baxter Bioscience
FloSeal Endoscopic Applicator , Product Code 1500181. The product is indicated in surgical procedures (other than in neurosurgical, opthalmic, and urological) as an adjunct to hemostasis when control
Terminated
LMFNone listed

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