Data / Medical devices / United States / DSM Biomedical, Inc.

DSM Biomedical, Inc.: FDA-registered device maker in Exton, PA, United States, 16 510(k) clearances

Name: DSM Biomedical, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

DSM Biomedical, Inc. is registered with the FDA (registration 2530154) in Exton, PA, United States. It lists 29 device types. The FDA files 16 510(k) clearances under its listings, the newest dated March 21, 2023. 12 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 2530154
FEI number: 1000307073
Address: 735 Pennsylvania Dr, Exton, PA, United States, 19341
Owner or operator: DSM BIOMEDICAL (9020253)
Roles: Contract manufacturer, Manufacturer
First device listed: January 26, 2006
Registered through: 2026
Brand names listed: COPIOS BONE VOID FILLER, DSM Biomedical Calcium Phosphate Cement, DSM Biomedical PRP Device, DSM Biomedical Porcine Pericardium Dental Membrane, DSM Dental Bone Graft, DSM Dental Bone Graft Plus, Delivery Needle, Delivery Syringe and Needle and more

Devices it lists

Device	Product code	Class	Role	Source
Barrier, Animal Source, Intraoral	NPL	2	Manufacturer	accessdata.fda.gov
Bone Grafting Material, Animal Source	NPM	2	Manufacturer	accessdata.fda.gov
Bone Grafting Material, Synthetic	LYC	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation	OIS	2	Manufacturer	accessdata.fda.gov
Fastener, Fixation, Biodegradable, Soft Tissue	MAI	2	Contract manufacturer	accessdata.fda.gov
Fastener, Fixation, Nondegradable, Soft Tissue	MBI	2	Contract manufacturer	accessdata.fda.gov
Filler, Bone Void, Calcium Compound	MQV	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Filler, Bone Void, Synthetic Peptide	NOX	3	Contract manufacturer	accessdata.fda.gov
Mesh, Surgical	FTM	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon	OWY	2	Manufacturer	accessdata.fda.gov
Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery	OXH	2	Manufacturer	accessdata.fda.gov
Mesh, Surgical, Collagen, Staple Line Reinforcement	OXE	2	Manufacturer	accessdata.fda.gov
Mesh, Surgical, Collagen, Thoracic, Chest Wall Reconstruction	OXB	2	Manufacturer	accessdata.fda.gov
Mesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed	PAJ	2	Manufacturer	accessdata.fda.gov
Mesh, Surgical, Non-Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator	PAG	2	Manufacturer	accessdata.fda.gov
Mesh, Surgical, Polymeric	FTL	2	Contract manufacturer	accessdata.fda.gov
Mixer, Cement, For Clinical Use	JDZ	1	Contract manufacturer	accessdata.fda.gov
Needle, Aspiration And Injection, Disposable	GAA	1	Contract manufacturer	accessdata.fda.gov
Pin, Fixation, Smooth	HTY	2	Contract manufacturer	accessdata.fda.gov
Plate, Bone	JEY	2	Contract manufacturer	accessdata.fda.gov
Plate, Cranioplasty, Preformed, Alterable	GWO	2	Contract manufacturer	accessdata.fda.gov
Platelet And Plasma Separator For Bone Graft Handling	ORG	2	Manufacturer	accessdata.fda.gov
Resorbable Implant For Anterior Cruciate Ligament (Acl) Repair	QNI	2	Contract manufacturer	accessdata.fda.gov
Screw, Fixation, Bone	HWC	2	Contract manufacturer	accessdata.fda.gov
Staple, Fixation, Bone	JDR	2	Contract manufacturer	accessdata.fda.gov
Suture, Nonabsorbable, Silk	GAP	2	Contract manufacturer	accessdata.fda.gov
Suture, Nonabsorbable, Synthetic, Polyethylene	GAT	2	Contract manufacturer	accessdata.fda.gov
Syringe, Piston	FMF	2	Contract manufacturer	accessdata.fda.gov
Wound Dressing With Animal-Derived Material(S)	KGN	U	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
March 21, 2023	K230054	DSM Biomedical Calcium Phosphate Cement	MQV	Substantially Equivalent	Dsm Biomedical	accessdata.fda.gov
September 10, 2020	K193212	DSM Biomedical Dental Bone Graft Plus	NPM	Substantially Equivalent	Dsm Biomedical	accessdata.fda.gov
April 3, 2018	K173362	DSM Biomedical Calcium Phosphate Cement	MQV	Substantially Equivalent	Kensey Nash Corporation Dba Dsm Biomedical	accessdata.fda.gov
May 16, 2017	K170245	DSM Biomedical Dental Bone Graft	NPM	Substantially Equivalent	Kensey Nash Corporation Dba Dsm Biomedical	accessdata.fda.gov
June 7, 2016	K160474	DSM Biomedical Porcine Pericardium Dental Membrane	NPL	Substantially Equivalent	Kensey Nash Corporation Dba Dsm Biomedical	accessdata.fda.gov
December 20, 2013	K133169	MESO TENDON MATRIX	OWY	Substantially Equivalent	Kensey Nash Corporation Dba Dsm Biomedical	accessdata.fda.gov
July 11, 2013	K121310	MESOTHELIUM DENTAL MEMBRANE	NPL	Substantially Equivalent	Kensey Nash Corporation	accessdata.fda.gov
February 10, 2012	K112888	MESO WOUND MATRIX	KGN	Substantially Equivalent	Kensey Nash Corporation	accessdata.fda.gov
February 7, 2011	K103787	MEDEOR MATRIX	FTM	Substantially Equivalent	Kensey Nash Corp.	accessdata.fda.gov
May 18, 2010	K094061	KENSEY NASH ECM SURGICAL PATCH	FTM	Substantially Equivalent	Kensey Nash Corporation	accessdata.fda.gov
October 22, 2009	K091499	MEDEOR MATRIX, MODELS 30010-XX (HYDRATED); 30020-XX (DRY)	FTM	Substantially Equivalent	Kensey Nash Corp.	accessdata.fda.gov
October 2, 2009	K090919	KENSEY NASH FIBRILLAR COLLAGEN DENTAL MEMBRANE	NPL	Substantially Equivalent	Kensey Nash Corp.	accessdata.fda.gov
September 21, 2007	K072384	MODIFICATION TO COPIOS BONE VOID FILLER SPONGE & PASTE	MQV	Substantially Equivalent	Kensey Nash Corp.	accessdata.fda.gov
June 1, 2007	K071237	COPIOS BONE VOID FILLER SPONGE AND PASTE	MQV	Substantially Equivalent	Kensey Nash Corp.	accessdata.fda.gov
July 7, 2004	K033679	COPSIOS BONE VOID FILLER (BVF)	MQV	Substantially Equivalent	Centerpulse Spine-Tech, Inc.	accessdata.fda.gov
October 15, 1996	K940643	OSMED EPI-GUIDE	LYC	Substantially Equivalent	Thm Biomedical, Inc.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
August 20, 2015	72054	Class II	Terminated	Aliquot Delivery Kit (Syringe and Plunger); for use in open and percutaneous procedures to facilitate placement of bone cement in weakened or diminished bone	Two isolated instances of holes in the outer header bag component of the double barrier sterile packaging configuration	accessdata.fda.gov
February 26, 2015	70609	Class II	Terminated	Vitagel; indicated in surgical procedures (other than in neurosurgical and ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.	Several shipments of Vitagel product (a surgical hemostat) required to be stored at 2 -8 degrees Celsius (C) were not delivered to customers within the validated delivery time.	accessdata.fda.gov
December 4, 2014	69979	Class II	Terminated	Stryker Orthobiologics Imbibe Aliquot Needle Bone Cement Needle- Model Numbers: 2110-0505 Beveled Needle, 11 gauge x 4 inch 2110-0524 Beveled Needle, 11 gauge x 6 inch 2110-0506 Diamond Needle, 11 gauge x 4 inch 2110-052	There is the potential for a breach in the inner or outer packaging pouches of all lots of the Stryker Orthobiologics Imbibe Aliquot Needle Bone Cement Needle.	accessdata.fda.gov
November 10, 2012	63204	Class II	Terminated	Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger Delivery System, 4", Part Number 2090-0502 Product Usage: Facilitate placement of bone cement in weakened or diminished bone	There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the needle during vertebroplasty procedures. This has been attributed to bending of the catheter during the retraction from the needle. It was determined to be use errors. The correction is limited to a revision of the Directions for Use.	accessdata.fda.gov
July 26, 2012	62834	Class II	Terminated	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.	When preparing plasma using VitaPrep, it was reported that a small amount of blood collected in the bottom of the centrifuge cup following the centrifugation step. Firm has since discovered that if blood is present in the Luer connection of the VitaPrep following the blood draw step, this blood could be displaced to the outside of the syringe when the VitaPr	accessdata.fda.gov
February 28, 2012	61819	Not yet classified	Terminated	a translucent, rectangular, resorbable, collagen membrane sheet derived from bovine tissue. Colla Guide Collagen Membrane Distributed by: Riemser Inc., PO Box 12339 Research Triangle Park, NC 27709-2339 USA Kensey Nash C	Recall has been initiated due to concerns regarding the sterility of the product. The firm initiated the recall because of use of inadequately sterilized product might result in patient infection	accessdata.fda.gov
March 31, 2011	58478	Not yet classified	Terminated	Orthovita(R) Cortoss(TM) Delivery Gun Product Usage: Used for the application of Cortoss(TM) Bone Augmentation Material	Recalling firm has discovered through internal testing that the Cortoss(TM) Delivery Gun may abrade its packaging material under certain transportation and handling conditions. This abrasion may cause small holes or tears in the packaging material, which may not be immediately visible to the user. Although t the Cortoss(TM) Delivery Gun is provided in double	accessdata.fda.gov
May 21, 2007	38055	Not yet classified	Terminated	ThromCat Thrombectomy Catheter System. Catalog number 63000-01	Defective component (power supply)	accessdata.fda.gov
March 28, 2007	37701	Not yet classified	Terminated	TriActiv FX Embolic Protection System 7F, Catalog numbers 60040-02 (has 190 cm guidewire) and 60040-03 (has 300 cm guidewire). The devices are comprised of four principal components including the ShieldWire Balloon Guide	Insufficient wire sealing	accessdata.fda.gov
February 7, 2007	37393	Not yet classified	Terminated	ThromCat Thrombectomy Catheter System. 7F 2.5 -7.0 mm 150 cm. Catalogue number 63000-01. It is a single-use, disposable device that is used to perform percutaneous maceration and removal of thrombus and restoration of bl	Face seal may wear excessively and cause particulate matter.	accessdata.fda.gov
May 24, 2006	35680	Not yet classified	Terminated	TriActiv System Procedure Kit. Balloon Protected Flush Extraction System 190 cm (for embolism protection). The kit includes AutoStream Flow Control, Flush Kit, ShieldWire (temporary occlusion balloon guidewire), and Ball	Volume control knob not able to go up to larger diameters	accessdata.fda.gov
April 6, 2006	35280	Not yet classified	Terminated	TriActiv ProGuard Embolic Protection System, Part number 61000-01. The product is shipped as a procedure kit. It is used with a standard 6F guide catheter using the standard femoral approach.	Alarm activiation-A priming issue involving the flow control unit due to a software problem has caused false postive Extraction Line Block (ELB) alarming. Use of this product may result in a health hazard resulting from early termination of the flush and extraction procedure after stenting	accessdata.fda.gov

Compare with other makers

Updated March 21, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.