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)
Top companies in LMF
| Company | 510(k)s | Recalls |
|---|---|---|
| Superstat Corp | 0 | 13 |
| Ethicon, Inc. | 0 | 4 |
| Integra LifeSciences Corporation | 0 | 4 |
| Baxter Healthcare Corporation | 0 | 2 |
| Baxter Bioscience | 0 | 1 |
| Davol, Inc. | 0 | 1 |
| Mckesson Medical-Surgical Inc. Corporate Office | 0 | 1 |
| Stryker Orthobiologics, Inc. | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 21, 2026 | Davol, Inc. Avitene Ultrafoam Microfibrillar Collagen Hemostat - 8cm x 6.25cm x 1cm. Catalog Number: 1050030. Open, Classified |
LMF | None listed |
| May 22, 2024 | Ethicon, Inc. SURGIFOAM" Absorbable Gelatin Powder Kit, Product Code 1979. Open, Classified |
LMF | None listed |
| Jan 5, 2024 | Baxter Healthcare Corporation Baxter FloSeal Hemostatic Matrix RECOTHROM, Product Codes:
a) ADS202105, 5mL-6 PK US
b) ADS202110, 10mL US Open, Classified |
LMF | None listed |
| Jan 5, 2024 | Baxter Healthcare Corporation Baxter Floseal Hemostatic Matrix Fast Prep, Product Codes:
a) ADS201844, 5 mL
b) ADS201845, 10mL Open, Classified |
LMF | None listed |
| Aug 26, 2022 | Mckesson 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 |
LMF | None listed |
| May 10, 2013 | Integra LifeSciences Corporation Absorbable Collagen Sponge
Provided As Intermediate to Another Company Terminated |
LMF | None listed |
| May 10, 2013 | Integra 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 |
LMF | None listed |
| May 10, 2013 | Integra 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 |
LMF | None listed |
| May 10, 2013 | Integra 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 |
LMF | None listed |
| Nov 22, 2012 | Stryker 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 |
LMF | None listed |
| Nov 16, 2012 | Superstat 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 |
LMF | None listed |
| Nov 16, 2012 | Superstat 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 |
LMF | None listed |
| Nov 16, 2012 | Superstat 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 |
LMF | None listed |
| Nov 16, 2012 | Superstat 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 |
LMF | None listed |
| Nov 16, 2012 | Superstat 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 |
LMF | None listed |
| Nov 16, 2012 | Superstat 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 |
LMF | None listed |
| Nov 16, 2012 | Superstat 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 |
LMF | None listed |
| Nov 16, 2012 | Superstat 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 |
LMF | None listed |
| Nov 16, 2012 | Superstat 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 |
LMF | None listed |
| Nov 16, 2012 | Superstat 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 |
LMF | None listed |
| Nov 16, 2012 | Superstat 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 |
LMF | None listed |
| Nov 16, 2012 | Superstat 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 |
LMF | None listed |
| Nov 16, 2012 | Superstat 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 |
LMF | None listed |
| Nov 16, 2012 | Ethicon, 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 |
LMF | None listed |
| Nov 16, 2012 | Ethicon, 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 |
LMF | None listed |
| Jun 27, 2012 | Ethicon, 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 |
LMF | None listed |
| Sep 20, 2008 | Baxter 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 |
LMF | None listed |
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