Data / Medical devices / Italy / Biopsybell S.R.L.

Biopsybell S.R.L.: FDA-registered device maker in MIRANDOLA Modena, Italy, 6 510(k) clearances

Name: Biopsybell S.R.L. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Biopsybell S.R.L. is registered with the FDA (registration 9617616) in MIRANDOLA Modena, Italy. It lists 16 device types. The FDA files 6 510(k) clearances under its listings, the newest dated October 30, 2023. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 9617616
FEI number: 3003272754
Address: Via A.Manuzio n.24, MIRANDOLA Modena, Italy, 41037
Owner or operator: BIOPSYBELL S.R.L. (9050785)
Roles: Exporter to the US, Manufacturer, Repackager or relabeler
First device listed: May 30, 2002
Registered through: 2027
Brand names listed: AUTOMATIC GUILLOTINE NEEDLE, BONE ACCESS NEEDLE, BONE MARROW MSC ASPIRATION KIT- MARROW- KIT, BONE MARROW MSC ASPIRATION KIT- MARROW-PACK, BONE MARROW MSC ASPIRATION KIT- MARROW-SET, BONE MARROW MSC ASPIRATION KIT- MARROW-STEM, BONE MARROW MSC ASPIRATION KIT- MARROW-TRAY, BonOs Inject and more

Devices it lists

Device	Product code	Class	Role	Source
Arthroscope	HRX	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Biopsy Needle	FCG	2	Manufacturer	accessdata.fda.gov
Bone Cement	LOD	2	Exporter to the US	accessdata.fda.gov
Bone Cement, Posterior Screw Augmentation	PML	2	Exporter to the US	accessdata.fda.gov
Brace, Drill	HXY	1	Manufacturer	accessdata.fda.gov
Cement, Bone, Vertebroplasty	NDN	2	Exporter to the US, Manufacturer, Repackager or relabeler	accessdata.fda.gov
Condenser, Heat And Moisture (Artificial Nose)	BYD	1	Manufacturer	accessdata.fda.gov
Device, Percutaneous, Biopsy	MJG	1	Manufacturer	accessdata.fda.gov
Guide, Needle, Surgical	GDF	1	Manufacturer	accessdata.fda.gov
Injector, Vertebroplasty (Does Not Contain Cement)	OAR	1	Manufacturer	accessdata.fda.gov
Instrument, Biopsy	KNW	2	Manufacturer	accessdata.fda.gov
Mixer, Cement, For Clinical Use	JDZ	1	Manufacturer	accessdata.fda.gov
Needle, Aspiration And Injection, Disposable	GAA	1	Manufacturer	accessdata.fda.gov
Orthopedic Manual Surgical Instrument	LXH	1	Manufacturer	accessdata.fda.gov
Spinal Channeling Instrument, Vertebroplasty	OCJ	1	Manufacturer	accessdata.fda.gov
Thoracolumbosacral Pedicle Screw System	NKB	2	Exporter to the US	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
October 30, 2023	K231340	Renova Spine Balloon Catheter	NDN	Substantially Equivalent	Biopsybell S.R.L.	accessdata.fda.gov
May 18, 2021	K202458	BonOs Inject, Pedicle screw kits, Cement pusher	LOD	Substantially Equivalent	Osartis GmbH	accessdata.fda.gov
January 11, 2021	K203397	Marrow-Pack (white)- 11gauge/10cm or 13gauge/10cm, Marrow-Tray (red)- 11gauge/10cm or 13gauge/10cm, Marrow-Set (violet)- 11gauge/10cm or 13gauge/10cm, Marrow-kit (grey)- 11gauge/10cm or 13gauge/10cm, Marrow-Stem (green)- 11gauge/10cm or 13gauge/10cm	KNW	Substantially Equivalent	Biopsybell S.R.L.	accessdata.fda.gov
March 26, 2018	K180315	DISKOM	HRX	Substantially Equivalent	Biopsybell S.R.L.	accessdata.fda.gov
April 16, 2014	K132620	INTER V KYPHOPLASTY CATHETER (BALLOON LENGTH: 0 MM), INTERV KYPHOPLASTY CATHETER (BALLOON LENGHT: 15 MM), INTERV KYPHOPL	NDN	Substantially Equivalent	Pan Medical , Ltd.	accessdata.fda.gov
February 7, 2014	K130616	MANUAL-BONE-MARROW-BIOPSY-NEEDLES, SEMI-AUTOMATIC-BIOPSY-NEEDLES, AUTOMATIC-BIOPSY-NEEDLES	KNW	Substantially Equivalent	Biopsybell S.R.L.	accessdata.fda.gov

Recalls

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

Initiated	Event	Class	Status	Product	Reason	Source
March 22, 2021	87696	Class II	Terminated	BPB medica CEMIX, PRODUCT NUMBER KVTMIXN, Vertebroplasty-Kyphoplasty cement mixing system	Products labeled as sterile were distributed, but may not have been sterilized.	accessdata.fda.gov

Compare with other makers

Updated October 30, 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.