Data / Medical devices / Australia / Arthrex Australia Pty Ltd.

Arthrex Australia Pty Ltd.: FDA-registered device maker in Frenchs Forest New South Wales, Australia, 173 510(k) clearances

Name: Arthrex Australia Pty Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Arthrex Australia Pty Ltd. is registered with the FDA (registration 3019269298) in Frenchs Forest New South Wales, Australia. It lists 63 device types. The FDA files 173 510(k) clearances under its listings, the newest dated July 25, 2024. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3019269298
Address: Suite 501, 20 Rodborough Road, Frenchs Forest New South Wales, Australia, 2086
Owner or operator: ARTHREX, INC. (1220287)
Roles: Exporter to the US
First device listed: January 27, 1994
Registered through: 2027
Brand names listed: ACL TightRope, ACL TightRope Double Bundle, ANATOEMIC PROSTHESIS, ARTHREX ANATOEMIC P, ARTHROERESIS IMPLANT, ARTHROSCOPY LEG HOLDER, Apparatus, Traction, Non-Powered, Arthrex Ankle Fusion Plating System and more

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Arthroscopic	NBH	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
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
Bone Wedge	PLF	2	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
Cerclage, Fixation	JDQ	2	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
Display, Cathode-Ray Tube, Medical	DXJ	2	Exporter to the US	accessdata.fda.gov
Electrosurgical, Cutting & Coagulation & Accessories	GEI	2	Exporter to the US	accessdata.fda.gov
Expander, Surgical, Skin Graft	FZW	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
Forceps	HTD	1	Exporter to the US	accessdata.fda.gov
Gauge, Depth	HTJ	1	Exporter to the US	accessdata.fda.gov
Instrument, Cutting, Orthopedic	HTZ	1	Exporter to the US	accessdata.fda.gov
Instrument, Manual, Surgical, General Use	MDM	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
Insufflator, Endoscopic Vessel Harvesting	OSV	2	Exporter to the US	accessdata.fda.gov
Insufflator, Laparoscopic	HIF	2	Exporter to the US	accessdata.fda.gov
Laparoscope, General & Plastic Surgery	GCJ	2	Exporter to the US	accessdata.fda.gov
Medical Device Data System	OUG	1	Exporter to the US	accessdata.fda.gov
Needle, Suturing, Disposable	GAB	1	Exporter to the US	accessdata.fda.gov
Operating Room Accessories Table Tray	FWZ	1	Exporter to the US	accessdata.fda.gov
Orthopedic Manual Surgical Instrument	LXH	1	Exporter to the US	accessdata.fda.gov
Passer	HWQ	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
Pliers, Surgical	HTC	1	Exporter to the US	accessdata.fda.gov
Probe	HXB	1	Exporter to the US	accessdata.fda.gov
Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	HSD	2	Exporter to the US	accessdata.fda.gov
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	KWS	2	Exporter to the US	accessdata.fda.gov
Prosthesis, Toe, Hemi-, Phalangeal	KWD	2	Exporter to the US	accessdata.fda.gov
Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained	PKC	2	Exporter to the US	accessdata.fda.gov
Protector, Skin Pressure	FMP	1	Exporter to the US	accessdata.fda.gov
Punch, Surgical	LRY	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
Shoulder Prosthesis, Reverse Configuration	PHX	2	Exporter to the US	accessdata.fda.gov
Source, Carrier, Fiberoptic Light	EQH	1	Exporter to the US	accessdata.fda.gov
Staple Driver	HXJ	1	Exporter to the US	accessdata.fda.gov
Staple, Absorbable	MNU	2	Exporter to the US	accessdata.fda.gov
Staple, Fixation, Bone	JDR	2	Exporter to the US	accessdata.fda.gov
Suture, Nonabsorbable, Silk	GAP	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, Digital Image Communications, Radiological	LMD	1	Exporter to the US	accessdata.fda.gov
System, Image Processing, Radiological	LLZ	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
Template	HWT	1	Exporter to the US	accessdata.fda.gov
Total Shoulder Arthroplasty System	QHQ	2	Exporter to the US	accessdata.fda.gov
Tray, Surgical, Instrument	FSM	1	Exporter to the US	accessdata.fda.gov
Tubing, Noninvasive	GAZ	2	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. Newest 100 of 173.

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
November 15, 2023	K232973	Arthrex Knee FiberTak® Button Suture Anchor	MBI	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
September 1, 2023	K232340	Arthrex 2.4mm Knotless Hip SutureTak® Suture Anchor	MBI	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
August 24, 2023	K230976	Arthrex Radiopaque FiberTape Cerclage sutures	JDQ	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
August 8, 2023	K231857	Arthrex TightRope II	MBI	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
June 1, 2023	K231330	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
April 1, 2023	K230568	FiberTak Suture Anchor	MBI	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
March 10, 2023	K230433	Arthrex Knotless FiberTak Suture Anchor	MBI	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
February 2, 2023	K223284	SutureLoc Implant	MBI	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
December 20, 2022	K221031	Arthrex DualCompression Hindfoot Fusion Nail Implant System	HSB	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
September 30, 2022	K222244	Arthrex 3.5 mm Locking Compression Plates	HRS	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
September 19, 2022	K220839	Arthrex Compression FT Pins	HWC	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
September 7, 2022	K221731	FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire	MBI	Substantially Equivalent	T.A.G. Medical Products Corporation, Ltd.	accessdata.fda.gov
August 26, 2022	K222263	Arthrex Self Punching SwiveLock Suture Anchors	MAI	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
August 22, 2022	K221485	Arthrex FiberTape and TigerTape Cerclage Sutures	HTN	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
May 2, 2022	K213837	Arthrx Fracture Plates	HRS	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
December 17, 2021	K213644	Arthrex Knotless Mini TightRopes	HTN	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
October 25, 2021	K212146	Arthrex LoopLoc Knotless Suture	GAT	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
February 3, 2021	K203294	Arthrex Pilon Fusion System	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 17, 2020	K202444	Knotless TensionTight Button Implant System	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
September 2, 2020	K201677	Arthrex Mesh Plates	HRS	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
July 27, 2020	K201132	Arthrex Compression Screws	HRS	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
July 24, 2020	K193575	Arthrex SutureTape	GAT	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
July 8, 2020	K201542	Arthrex Eclipse Shoulder Prosthesis System	PKC	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
July 8, 2020	K193345	Arthrex DynaNite Compression Plate	HRS	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
June 29, 2020	K200068	Arthrex DynaNite K-Wire	HTY	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
March 12, 2020	K200341	Arthrex FiberTak Suture Anchor	MBI	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
January 15, 2020	K193503	Arthrex SwiveLock Suture Anchor	MAI	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
January 10, 2020	K193372	Univers Revers Modular Glenoid System (Augemented baseplates)	PHX	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
December 12, 2019	K193157	Arthrex 3.9mm Corkscrew Suture Anchor	MAI	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
November 6, 2019	K191651	Arthrex Nano SwiveLock Suture Anchor	HWC	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
October 30, 2019	K190921	Arthrex Low Profile Screws	HWC	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
October 16, 2019	K190953	Arthrex Minimally Invasive Ankle Fusion Plate	HRS	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
October 15, 2019	K191326	Arthrex Mini Comprehensive Fixation System 1.4mm & 1.6mm Module	HRS	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
October 3, 2019	K191344	Arthrex Mini Comprehensive Fixation System 2.0mm & 2.4mm Module	HRS	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
September 13, 2019	K190288	Arthrex Tenodesis Button	MBI	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
July 26, 2019	K183194	Arthrex Eclipse Shoulder Prosthesis System	QHQ	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
June 11, 2019	K191226	Arthrex SwiveLock Suture Anchor	MAI	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
May 3, 2019	K190287	Arthrex DynaNite® PIP (Hammertoe) Implant	HTY	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
April 17, 2019	K183395	Arthrex 2.5 mm Tenodesis Screw	HWC	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
September 21, 2018	K181769	Arthrex FiberTak Suture Anchor	MBI	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
August 30, 2018	K181513	Arthrex PushLock Tenodesis Anchor	MBI	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
August 6, 2018	K173845	Arthrex SwiveLock	MBI	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
July 26, 2018	K173656	Arthrex FibuLock Nail	HSB	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
June 22, 2018	K180594	Knotless SutureTak Anchors	MAI	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
May 22, 2018	K180662	Arthrex FastThread Interference Screw	MAI	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
April 20, 2018	K173900	Arthrex Univers Revers Modular Glenoid System	PHX	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
March 1, 2018	K173788	Arthrex Corkscrew FT	MAI	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
February 22, 2018	K173381	Nexxis OR	DXJ	Substantially Equivalent	Barco N.V.	accessdata.fda.gov
February 12, 2018	K180118	Arthrex NanoSuture Anchor	MBI	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
November 15, 2017	K170206	Arthrex FiberTape Cerclage	JDQ	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
September 28, 2017	K172612	FiberTak DX	MBI	Substantially Equivalent	Arthex, Inc.	accessdata.fda.gov
September 1, 2017	K170547	Arthrex Mesh Plate System	HRS	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
May 26, 2017	K171296	SutureTape	GAT	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
February 10, 2017	K162697	Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex OrthoVis Preoperative Plan, SmartBase for Arthrex Glenoid IRIS, ArthrexVIP Web Portal	KWS	Substantially Equivalent	Custom Orthopaedic Solutions, Inc.	accessdata.fda.gov
November 21, 2016	K161782	Arthrex Univers Revers Shoulder Prosthesis System	HSD	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
September 9, 2016	K161581	Arthrex Synergy RF System	GEI	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
August 29, 2016	K161108	Arthrex VaultLock Glenoid	KWS	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
March 24, 2016	K151342	Arthrex SwiveLock Anchors	MAI	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
March 4, 2016	K153513	Insufflator 50L FM134	HIF	Substantially Equivalent	W.O.M. World of Medicine GmbH	accessdata.fda.gov
February 23, 2016	K151092	Arthrex Short Suture Anchors	MBI	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
February 12, 2016	K153218	Arthrex Synergy UHD4 System	GCJ	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
August 28, 2015	K151732	Arthrex Fracture Plates	HRS	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
August 20, 2015	K150648	Arthrex DX SwiveLock SL with Forket Eyelet 3.5 x 8.5mm, Arthrex DX SwiveLock Suture Anchor, 3.5 x 13.5mm	MBI	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
August 12, 2015	K151256	Arthrex BioSync® Bone Wedge	PLF	Substantially Equivalent	Arthex, Inc.	accessdata.fda.gov
July 7, 2015	K151543	Graft Delivery Device with Integrated Stylet	FMF	Substantially Equivalent	Micromedics, Inc. (D/B/A Nordson Medical)	accessdata.fda.gov
July 2, 2015	K143745	Arthrex Corkscrew and SwiveLock Suture Anchors	MBI	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
June 19, 2015	K151230	Arthrex FiberTak Anchors	MBI	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
May 15, 2015	K151078	Arthrex RetroFusion Screw	HWC	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
April 3, 2015	K143749	Arthrex Distal Radius System	HRS	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
January 16, 2015	K143614	Arthrex Low Profile Screws	HWC	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
January 16, 2015	K143139	Arthrex Fracture System	HRS	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
December 18, 2014	K140855	ARTHREX SUTURETAK SUTURE ANCHORS	MAI	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
November 25, 2014	K142863	Univers Rivers Shoulder Prosthesis System	PHX	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
August 15, 2014	K141735	ARTHREX ANKLE FUSION PLATING SYSTEM	HRS	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
July 18, 2014	K141577	ARTHREX PIP DART	HTY	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
July 8, 2014	K141478	ARTHREX FRACTURE PLATES AND SCREWS	HRS	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
January 30, 2014	K133275	MINI TIGHTROPE	HTN	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
November 25, 2013	K132217	ARTHREX COMPRESSION FT SCREWS	HWC	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
July 31, 2013	K132043	ARTHREX SPEEDCINCH	GAT	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
July 3, 2013	K131474	ARTHREX DISTAL RADIUS PLATE SYSTEM	HRS	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
May 31, 2013	K130129	UNIVERS REVERS SHOULDER PROSTHESIS SYSTEM	KWS	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
May 3, 2013	K130458	KNOTLESS FIBERTAK SUTURE ANCHOR	MBI	Substantially Equivalent	Arthrex, Inc.	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.