Data / Medical devices / Ecuador / Biocells Discoveries Internacional (biocells)

Biocells Discoveries Internacional (biocells): FDA-registered device maker in Quito Pichincha, Ecuador, 53 510(k) clearances

Name: Biocells Discoveries Internacional (biocells) FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Biocells Discoveries Internacional (biocells) is registered with the FDA (registration 3021336182) in Quito Pichincha, Ecuador. It lists 37 device types. The FDA files 53 510(k) clearances under its listings, the newest dated July 25, 2024. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3021336182
Address: Francisco Casanova and Portugal, Quito Pichincha, Ecuador, 170504
Owner or operator: Biocells Discoveries Internacional (Biocells) (10083835)
Roles: Exporter to the US
First device listed: December 22, 2021
Registered through: 2026
Brand names listed: ACCESSORIES, PHOTOGRAPHIC, FOR ENDOSCOPE (EXCLUDE LIGHT SOURCES), Accessories, arthroscopic, Apparatus, traction, non-powered, Arthrex Plates, Screws, and Staples, Arthrex SwiveLock Anchor, BALANCE, ANALYTICAL, BEDDING, DISPOSABLE, MEDICAL, BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL and more

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Arthroscopic	NBH	1	Exporter to the US	accessdata.fda.gov
Accessories, Photographic, For Endoscope (Exclude Light Sources)	FEM	1	Exporter to the US	accessdata.fda.gov
Apparatus, Traction, Non-Powered	HST	1	Exporter to the US	accessdata.fda.gov
Arthroscope	HRX	2	Exporter to the US	accessdata.fda.gov
Balance, Analytical	JQO	1	Exporter to the US	accessdata.fda.gov
Bedding, Disposable, Medical	KME	1	Exporter to the US	accessdata.fda.gov
Bit, Drill	HTW	1	Exporter to the US	accessdata.fda.gov
Blade, Saw, General & Plastic Surgery, Surgical	GFA	1	Exporter to the US	accessdata.fda.gov
Bur, Surgical, General & Plastic Surgery	GFF	1	Exporter to the US	accessdata.fda.gov
Camera, Surgical And Accessories	KQM	1	Exporter to the US	accessdata.fda.gov
Camera, Television, Surgical, Without Audio	FWB	1	Exporter to the US	accessdata.fda.gov
Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use	JQC	1	Exporter to the US	accessdata.fda.gov
Component, Traction, Non-Invasive	KQZ	1	Exporter to the US	accessdata.fda.gov
Controller, Foot, Handpiece And Cord	EBW	1	Exporter to the US	accessdata.fda.gov
Fastener, Fixation, Biodegradable, Soft Tissue	MAI	2	Exporter to the US	accessdata.fda.gov
Fastener, Fixation, Nondegradable, Soft Tissue	MBI	2	Exporter to the US	accessdata.fda.gov
Instrument, Manual, Surgical, General Use	MDM	1	Exporter to the US	accessdata.fda.gov
Instrument, Special Lens, For Endoscope	FEI	1	Exporter to the US	accessdata.fda.gov
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	HWE	1	Exporter to the US	accessdata.fda.gov
Laparoscope, General & Plastic Surgery	GCJ	2	Exporter to the US	accessdata.fda.gov
Light, Surgical, Fiberoptic	FST	2	Exporter to the US	accessdata.fda.gov
Medical Device Data System	OUG	1	Exporter to the US	accessdata.fda.gov
Orthopedic Manual Surgical Instrument	LXH	1	Exporter to the US	accessdata.fda.gov
Pin, Fixation, Smooth	HTY	2	Exporter to the US	accessdata.fda.gov
Plate, Fixation, Bone	HRS	2	Exporter to the US	accessdata.fda.gov
Platelet And Plasma Separator For Bone Graft Handling	ORG	2	Exporter to the US	accessdata.fda.gov
Probe	HXB	1	Exporter to the US	accessdata.fda.gov
Protector, Skin Pressure	FMP	1	Exporter to the US	accessdata.fda.gov
Reamer	HTO	1	Exporter to the US	accessdata.fda.gov
Rod, Fixation, Intramedullary And Accessories	HSB	2	Exporter to the US	accessdata.fda.gov
Screw, Fixation, Bone	HWC	2	Exporter to the US	accessdata.fda.gov
Staple, Fixation, Bone	JDR	2	Exporter to the US	accessdata.fda.gov
Suture, Nonabsorbable, Synthetic, Polyethylene	GAT	2	Exporter to the US	accessdata.fda.gov
Syringe, Piston	FMF	2	Exporter to the US	accessdata.fda.gov
System, X-Ray, Angiographic	IZI	2	Exporter to the US	accessdata.fda.gov
Table And Attachments, Operating-Room	BWN	1	Exporter to the US	accessdata.fda.gov
Washer, Bolt Nut	HTN	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
July 25, 2024	K241361	Arthrex Synergy Vision Endoscopic Imaging System	GCJ	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
May 29, 2024	K241235	Arthrex TightRope II	MBI	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
November 3, 2023	K232742	Arthrex FiberTak Suture Anchor	MBI	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
May 18, 2023	K231113	Arthrex FiberTak Suture Anchor	MBI	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
February 24, 2023	K223759	Arthrex SynergyID Endoscopic Imaging System	GCJ	Substantially Equivalent	Arthex, Inc.	accessdata.fda.gov
December 22, 2022	K221396	Arthrex FiberTak Suture Anchor	MBI	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
October 3, 2022	K222267	Arthrex 2.4 mm Volar Distal Radius Plate System	HRS	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
August 11, 2022	K222161	Arthrex Knotless FiberTak Biceps Suture Anchor	MBI	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
June 29, 2022	K220937	Arthrex Mini Fragment System	HRS	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
June 6, 2022	K220947	Arthrex Knotless AC Repair Devices	HTN	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
July 22, 2021	K202582	Arthrex SynergyID Endoscopic Imaging System	GCJ	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
April 19, 2021	K203495	Arthrex SwiveLock Anchor	MAI	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
March 25, 2021	K203834	Arthrex Patella SuturePlates	HRS	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
December 30, 2020	K203239	Arthrex Low Profile Screws	HWC	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
December 16, 2020	K203180	Arthrex DynaNite Nitinol Staples	JDR	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
November 27, 2020	K203268	Arthrex FiberTak Suture Anchor	MBI	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
November 4, 2020	K202581	Arthrex TightRope II	MBI	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
September 4, 2020	K201134	Arthrex NanoScope System	GCJ	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
September 3, 2020	K201522	Arthrex Syndesmosis TightRope XP Buttress Plate Implant System	HTN	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
July 6, 2020	K201235	Arthrex MaxForce MTP Compression Plates and Screws	HRS	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
March 12, 2020	K200341	Arthrex FiberTak Suture Anchor	MBI	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
November 26, 2019	K191426	FiberTak Button	MBI	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
September 21, 2018	K181769	Arthrex FiberTak Suture Anchor	MBI	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
July 26, 2018	K173656	Arthrex FibuLock Nail	HSB	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
May 22, 2018	K180662	Arthrex FastThread Interference Screw	MAI	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
September 28, 2017	K172612	FiberTak DX	MBI	Substantially Equivalent	Arthex, Inc.	accessdata.fda.gov
August 28, 2015	K151732	Arthrex Fracture Plates	HRS	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
June 19, 2015	K151230	Arthrex FiberTak Anchors	MBI	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
April 29, 2015	K150456	Arthrex Plates, Screws, and Staples	HRS	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
April 9, 2015	K143702	Arthrex Blunt Tip Screws with Fiber Tape	HTY	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
January 16, 2015	K143139	Arthrex Fracture System	HRS	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
July 8, 2014	K141478	ARTHREX FRACTURE PLATES AND SCREWS	HRS	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
March 10, 2014	K140328	CMC MINI TIGHTROPE	HTN	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
May 3, 2013	K130458	KNOTLESS FIBERTAK SUTURE ANCHOR	MBI	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
April 5, 2013	K123241	ARTHREX FRACTURE PLATES	HRS	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
May 16, 2012	K121124	ARTHREX MIXING AND DELIVERY SYSTEM	FMF	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
December 21, 2011	K112437	ARTHREX FRACTURE SYSTEM	HTN	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
August 2, 2011	K111253	ARTHREX DISTAL EXTREMITY PLATE SYSTEM	HRS	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
March 18, 2011	K103705	LOW PROFILE SCREWS	HWC	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
January 5, 2011	K103060	ARTHREX TIBIAL GRAFTBOLT	MBI	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
March 18, 2010	K093912	ARTHREX TIBIAL GRAFTBOLT	MBI	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
August 28, 2009	K091844	ARTHREX BIO-COMPOSITE SUTURETAK ANCHORS	MAI	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
August 6, 2009	K090107	MINI TIGHTROPE	HTN	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
February 13, 2008	K080111	ARTHREX COMPRESSION STAPLE	JDR	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
February 11, 2008	K073149	MENISCAL CINCH	GAT	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
August 15, 2007	K071756	ENDOHUB- 1.0 ENDOSCOPIC VIDEO CAMERA SYSTEM WITH VIDEO CAPTURE	GCJ	Substantially Equivalent	Pointe Conception Medical, Inc.	accessdata.fda.gov
May 3, 2006	K060287	DRILLTECH, ISM, IMPLANTUNIT, ZIMMER SURGICAL MOTOR SYSTEM	EBW	Substantially Equivalent	W&H Dentalwerk Buermoos GmbH	accessdata.fda.gov
May 3, 2002	K014068	ELCOMED, MODELS SA-200 C 230, SA-200 230, SA-200 C 115, SA-200 115	EBW	Substantially Equivalent	W&H Dentalwerk Buermoos GmbH	accessdata.fda.gov
February 7, 2001	K002469	IMPLANTMED SI-95 115 (100-130 V) AND SI-95 230 (220-240 V)	EBW	Substantially Equivalent	W&H Dentalwerk Buermoos GmbH	accessdata.fda.gov
July 30, 1997	K971723	FASTAK SUTURE ANCHOR (11.7MM)/(7.5MM)	MBI	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
May 16, 1994	K941541	HSV LAPAROSCOPY SET	GCJ	Substantially Equivalent	Henke Sass Wolf of America, Inc.	accessdata.fda.gov
January 25, 1994	K932699	ARTHREX AR-8200 SHAVER SYSTEM	HWE	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
April 23, 1990	K901035	FIBER OPTIC LIGHT GUIDE OR FIBER OPTIC CABLE	FST	Substantially Equivalent	Cuda Products Co.	accessdata.fda.gov

Compare with other makers

Updated July 25, 2024. 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.