Data / Medical devices / Hong Kong / Soher Med Limited

Soher Med Limited: FDA-registered device maker in Hong Kong, Hong Kong, 198 510(k) clearances

Name: Soher Med Limited FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Soher Med Limited is registered with the FDA (registration 3045857207) in Hong Kong, Hong Kong. It lists 74 device types. The FDA files 198 510(k) clearances under its listings, the newest dated December 9, 2021. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3045857207
Address: Suite C, Level 7, Word Trust Tower, 50 Stanley Sueet, Hong Kong, Hong Kong, 999077
Owner or operator: Soher Med Limited (10095823)
Roles: Exporter to the US
First device listed: May 5, 2026
Registered through: 2027
Brand names listed: AH Plus, Adhesive, Adhesive, Bracket, Air polish, Amalgam, Applicatory Resin, Bond, Bonding and more

Devices it lists

Device	Product code	Class	Role	Source
Absorber, Saliva, Paper	KHR	1	Exporter to the US	accessdata.fda.gov
Accessory, Surgical Apparel	LYU	1	Exporter to the US	accessdata.fda.gov
Activator, Ultraviolet, For Polymerization	EBZ	2	Exporter to the US	accessdata.fda.gov
Adhesive, Bracket And Tooth Conditioner, Resin	DYH	2	Exporter to the US	accessdata.fda.gov
Agent, Polishing, Abrasive, Oral Cavity	EJR	1	Exporter to the US	accessdata.fda.gov
Agent, Tooth Bonding, Resin	KLE	2	Exporter to the US	accessdata.fda.gov
Alloy, Amalgam	EJJ	2	Exporter to the US	accessdata.fda.gov
Applicator, Resin	KXR	1	Exporter to the US	accessdata.fda.gov
Blade, Scalpel	GES	1	Exporter to the US	accessdata.fda.gov
Bur, Dental	EJL	1	Exporter to the US	accessdata.fda.gov
Burnisher, Operative	EKJ	1	Exporter to the US	accessdata.fda.gov
Camera, Surgical And Accessories	KQM	1	Exporter to the US	accessdata.fda.gov
Cement, Dental	EMA	2	Exporter to the US	accessdata.fda.gov
Clamp, Rubber Dam	EEF	1	Exporter to the US	accessdata.fda.gov
Coating, Filling Material, Resin	EBD	2	Exporter to the US	accessdata.fda.gov
Cord, Retraction	MVL	U	Exporter to the US	accessdata.fda.gov
Crown And Bridge, Temporary, Resin	EBG	2	Exporter to the US	accessdata.fda.gov
Crown, Preformed	ELZ	1	Exporter to the US	accessdata.fda.gov
Cup, Prophylaxis	EHK	1	Exporter to the US	accessdata.fda.gov
Curette, Endodontic	EKT	1	Exporter to the US	accessdata.fda.gov
Dental Cement W/Out Zinc-Oxide Eugenol As An Ulcer Covering For Pain Relief	MZW	2	Exporter to the US	accessdata.fda.gov
Denture, Plastic, Teeth	ELM	2	Exporter to the US	accessdata.fda.gov
Disk, Abrasive	EHJ	1	Exporter to the US	accessdata.fda.gov
Drill, Dental, Intraoral	DZA	1	Exporter to the US	accessdata.fda.gov
Elevator, Surgical, Dental	EMJ	1	Exporter to the US	accessdata.fda.gov
Eraser, Dental Stain	MAU	1	Exporter to the US	accessdata.fda.gov
Explorer, Operative	EKB	1	Exporter to the US	accessdata.fda.gov
External Cleaning Solution	PME	2	Exporter to the US	accessdata.fda.gov
File, Periodontic	EMR	1	Exporter to the US	accessdata.fda.gov
File, Pulp Canal, Endodontic	EKS	1	Exporter to the US	accessdata.fda.gov
Film, Radiographic	IWZ	1	Exporter to the US	accessdata.fda.gov
Forceps, Tooth Extractor, Surgical	EMG	1	Exporter to the US	accessdata.fda.gov
Gutta-Percha	EKM	1	Exporter to the US	accessdata.fda.gov
Handle, Instrument, Dental	EJB	1	Exporter to the US	accessdata.fda.gov
Handpiece, Air-Powered, Dental	EFB	1	Exporter to the US	accessdata.fda.gov
Holder, Film, X-Ray	EGZ	1	Exporter to the US	accessdata.fda.gov
Instrument, Diamond, Dental	DZP	1	Exporter to the US	accessdata.fda.gov
Instrument, Filling, Plastic, Dental	EIY	1	Exporter to the US	accessdata.fda.gov
Instruments, Dental Hand	DZN	1	Exporter to the US	accessdata.fda.gov
Liner, Cavity, Calcium Hydroxide	EJK	2	Exporter to the US	accessdata.fda.gov
Maintainer, Space Preformed, Orthodontic	DYT	1	Exporter to the US	accessdata.fda.gov
Material, Impression	ELW	2	Exporter to the US	accessdata.fda.gov
Material, Tooth Shade, Resin	EBF	2	Exporter to the US	accessdata.fda.gov
Mirror, Mouth	EAX	1	Exporter to the US	accessdata.fda.gov
Needle, Dental	DZM	1	Exporter to the US	accessdata.fda.gov
Paper, Articulation	EFH	1	Exporter to the US	accessdata.fda.gov
Pin, Retentive And Splinting, And Accessory Instruments	EBL	1	Exporter to the US	accessdata.fda.gov
Plier, Orthodontic	JEX	1	Exporter to the US	accessdata.fda.gov
Plugger, Root Canal, Endodontic	EKR	1	Exporter to the US	accessdata.fda.gov
Point, Abrasive	EHL	1	Exporter to the US	accessdata.fda.gov
Point, Paper, Endodontic	EKN	1	Exporter to the US	accessdata.fda.gov
Post, Root Canal	ELR	1	Exporter to the US	accessdata.fda.gov
Powder, Porcelain	EIH	2	Exporter to the US	accessdata.fda.gov
Resin, Denture, Relining, Repairing, Rebasing	EBI	2	Exporter to the US	accessdata.fda.gov
Resin, Root Canal Filling	KIF	2	Exporter to the US	accessdata.fda.gov
Retainer, Matrix	JEP	1	Exporter to the US	accessdata.fda.gov
Saliva, Artificial	LFD	U	Exporter to the US	accessdata.fda.gov
Scaler, Periodontic	EMN	1	Exporter to the US	accessdata.fda.gov
Scaler, Ultrasonic	ELC	2	Exporter to the US	accessdata.fda.gov
Sealant, Pit And Fissure, And Conditioner	EBC	2	Exporter to the US	accessdata.fda.gov
Spreader, Pulp Canal Filling Material, Endodontic	EKK	1	Exporter to the US	accessdata.fda.gov
Strip, Polishing Agent	EHM	1	Exporter to the US	accessdata.fda.gov
Suture, Absorbable, Synthetic, Polyglycolic Acid	GAM	2	Exporter to the US	accessdata.fda.gov
Syringe, Periodontic, Endodontic, Irrigating	EIC	1	Exporter to the US	accessdata.fda.gov
Syringe, Restorative And Impression Material	EID	1	Exporter to the US	accessdata.fda.gov
System, X-Ray, Extraoral Source, Digital	MUH	2	Exporter to the US	accessdata.fda.gov
Teeth, Porcelain	ELL	2	Exporter to the US	accessdata.fda.gov
Toothbrush, Manual	EFW	1	Exporter to the US	accessdata.fda.gov
Tray, Impression, Preformed	EHY	1	Exporter to the US	accessdata.fda.gov
Tray, Surgical, Instrument	FSM	1	Exporter to the US	accessdata.fda.gov
Unit, Operative Dental, Accessories	NRD	1	Exporter to the US	accessdata.fda.gov
Unit, Syringe, Air And/Or Water	ECB	1	Exporter to the US	accessdata.fda.gov
Varnish, Cavity	LBH	2	Exporter to the US	accessdata.fda.gov
Wax, Dental, Intraoral	EGD	1	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 198.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
December 9, 2021	K213149	VOCO Retraction Paste	MVL	Substantially Equivalent	Voco GmbH	accessdata.fda.gov
November 22, 2019	K192260	everX Flow	EBF	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
October 8, 2019	K191133	KATANA Cleaner, KATANA Cleaner (Trial)	PME	Substantially Equivalent	Kuraray Noritake Dental, Inc.	accessdata.fda.gov
July 29, 2019	K190339	Helioseal F Plus	EBC	Substantially Equivalent	Ivoclar Vivadent, AG	accessdata.fda.gov
March 14, 2019	K183380	Tetric PowerFill	EBF	Substantially Equivalent	Ivoclar Vivadent, AG	accessdata.fda.gov
December 18, 2018	K181496	VINTAGE PRO	EIH	Substantially Equivalent	Shofu Dental Corporation	accessdata.fda.gov
March 8, 2018	K173500	NMF004A	EBF	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
February 27, 2018	K173275	OMNICHROMA	EBF	Substantially Equivalent	Tokuyama Dental Corporation	accessdata.fda.gov
April 4, 2017	K163613	Bluephase Style 20i	EBZ	Substantially Equivalent	Ivoclar Vivadent, AG	accessdata.fda.gov
September 27, 2016	K162107	TPH Spectra+ Universal Composite Restorative	EBF	Substantially Equivalent	Dentsply Sirona	accessdata.fda.gov
July 29, 2016	K153493	Clip Flow	EBF	Substantially Equivalent	Voco GmbH	accessdata.fda.gov
July 27, 2016	K160596	BEAUTIFIL II LS	EBF	Substantially Equivalent	Shofu Dental Corporation	accessdata.fda.gov
July 27, 2016	K153067	Tubli-Seal, Tubli-Seal EWT,Tubli-Seal Xpress, Tubli-Seal EWT Xpress	KIF	Substantially Equivalent	Sybron Dental Specialties	accessdata.fda.gov
July 6, 2016	K153231	G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi Primer	EMA	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
June 30, 2016	K153177	Admira Fusion Flow	EBF	Substantially Equivalent	Voco GmbH	accessdata.fda.gov
April 14, 2016	K152959	Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual-barrel syringes	KIF	Substantially Equivalent	Sybron Dental Specialties	accessdata.fda.gov
April 12, 2016	K153753	TelioCAD Multi	EBG	Substantially Equivalent	Ivoclar Vivadent, Inc.	accessdata.fda.gov
March 4, 2016	K152861	Aquasil Ultra + Smart Wetting Impression Material	ELW	Substantially Equivalent	Dentply International, Inc.	accessdata.fda.gov
March 3, 2016	K153253	GC Reline II	EBI	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
March 2, 2016	K151700	BEAUTIFIL II Gingiva	EBF	Substantially Equivalent	Shofu Dental Corporation	accessdata.fda.gov
December 10, 2015	K151699	BEAUTIFIL II Enamel	EBF	Substantially Equivalent	Shofu Dental Corporation	accessdata.fda.gov
July 31, 2015	K151053	PSPIX 2 scanner, Imaging Plate Size 0 for PSPIX2 scanner, Imaging Plate Size 1 for PSPIX2 scanner, Imaging Plate Size 2 for PSPIX2 scanner, Imaging Plate Size 3 for PSPIX2 scanner	MUH	Substantially Equivalent	Sopro - Acteon Group	accessdata.fda.gov
July 7, 2015	K150933	iBond Universal & iBond Ceramic Primer	KLE	Substantially Equivalent	Heraeus Kulzer, LLC, Mitsui Chemicals Group	accessdata.fda.gov
April 20, 2015	K143140	G-Premio BOND	KLE	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
November 25, 2014	K142389	Variolink Esthetic	EBF	Substantially Equivalent	Ivoclar Vivadent, AG	accessdata.fda.gov
September 5, 2014	K141562	MSN-006	EBG	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
March 14, 2014	K133824	CERASMART	EBF	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
March 6, 2014	K133836	OPTIGLAZE COLOR	EBD	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
February 11, 2014	K133318	ADHESE UNIVERSAL	KLE	Substantially Equivalent	Ivoclar Vivadent, AG	accessdata.fda.gov
November 1, 2013	K132450	CLEARFIL UNIVERSAL BOND VALUE PACK, CLEARFIL UNIVERSALY BOND TRIAL, CLEARFIL UNIVERSAL BOND	KLE	Substantially Equivalent	Kuraray Noritake Dental, Inc.	accessdata.fda.gov
October 3, 2013	K132141	BEAUTIFIL BULK FLOWABLE	EBF	Substantially Equivalent	Shofu Dental Corporation	accessdata.fda.gov
July 11, 2013	K131248	ETCH GEL	KLE	Substantially Equivalent	Dmg America, LLC	accessdata.fda.gov
December 7, 2012	K123278	IBOND SELF ETCH BOTTLE ASSORTMENT, IBOND SELF ETCH BOTTLE VALUE PACK, IBOND SELF ETCH SINGLE DOSE ASSORTMENT, IBOND SELF	KLE	Substantially Equivalent	Heraeus Kulzer, LLC	accessdata.fda.gov
August 29, 2012	K121230	IPS EMPRESS DIRECT COLOR IPS EMPRESS DIRECT OPAQUE	EBF	Substantially Equivalent	Ivoclar Vivadent, AG	accessdata.fda.gov
May 10, 2012	K120521	GC BLUE SILICONE	ELW	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
March 19, 2012	K120453	FILTEK BULK FILL FLOWABLE RESTORATIVE	EBF	Substantially Equivalent	3M Espe Dental Products	accessdata.fda.gov
December 14, 2011	K112501	VENUS PEARL PLT REFILL A1	EBF	Substantially Equivalent	Heraeus Kulzer, LLC	accessdata.fda.gov
November 17, 2011	K111982	CLEARFIL DC CORE PLUS	EBF	Substantially Equivalent	Kuraray America, Inc.	accessdata.fda.gov
October 14, 2011	K111958	TETRIC EVOCERAM BULK FILL	EBF	Substantially Equivalent	Ivoclar Vivadent, Inc.	accessdata.fda.gov
June 17, 2011	K110871	FIT CHECKER ADVANCED	ELW	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
May 19, 2011	K110302	ADHESIVE EXL-759	KLE	Substantially Equivalent	3M Espe AG	accessdata.fda.gov
May 5, 2011	K111185	RELYX LUTING PLUS AUTOMIX	EMA	Substantially Equivalent	3M Espe Dental Products	accessdata.fda.gov
February 25, 2011	K103528	IPS EMPRESS DIRECT FLOW	EBF	Substantially Equivalent	Ivoclar Vivadent, Inc.	accessdata.fda.gov
February 14, 2011	K103379	TELIO CS INLAY & TELIO CS ONLAY	EBG	Substantially Equivalent	Ivoclar Vivadent, Inc.	accessdata.fda.gov
January 27, 2011	K101346	GC ORAL MOISTURIZING GEL	LFD	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
December 22, 2010	K102808	MI VARNISH	LBH	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
October 21, 2010	K100172	TOKUYAMA SHIELD FORCE	LBH	Substantially Equivalent	Tokuyama Dental Corporation	accessdata.fda.gov
September 28, 2010	K101710	LUXATEMP ULTRA /STAR	EBG	Substantially Equivalent	Dmg USA, Inc.	accessdata.fda.gov
September 17, 2010	K101420	GC FUJI TEMP	EMA	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
August 23, 2010	K101603	BEAUTIFIL FLOW PLUS	EBF	Substantially Equivalent	Shofu Dental Corp.	accessdata.fda.gov
August 19, 2010	K101493	ADVANCED GLASS IONOMER (K-130) RESTORATIVE	EMA	Substantially Equivalent	Dentsply International, Inc.	accessdata.fda.gov
May 12, 2010	K100235	FILTEK SUPREME ULTRA FLOWABLE RESTORATIVE	EBF	Substantially Equivalent	3M Company	accessdata.fda.gov
March 10, 2010	K093744	EXCITE F AND EXCITE DSC	KLE	Substantially Equivalent	Ivoclar Vivadent, Inc.	accessdata.fda.gov
March 10, 2010	K092141	VANISH VARNISH, 5% SODIUM FLUORIDE WHITE VARNISH	LBH	Substantially Equivalent	3M Espe Dental Products	accessdata.fda.gov
March 5, 2010	K100328	CLEARFIL MAJETY POSTERIOR	EBF	Substantially Equivalent	Kuraray Medical, Inc.	accessdata.fda.gov
February 19, 2010	K093721	COSP2	MVL	Substantially Equivalent	3M Espe AG Dental Products	accessdata.fda.gov
July 31, 2009	K091494	FLEXITIME FLOW	ELW	Substantially Equivalent	Heraeus Kulzer, Inc.	accessdata.fda.gov
July 22, 2009	K091388	GCUC-505	EBF	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
June 17, 2009	K091106	EQUIA	EMA	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
June 4, 2009	K091019	SPEEDCEM	EMA	Substantially Equivalent	Ivoclar Vivadent, Inc.	accessdata.fda.gov
May 21, 2009	K091023	METAMORPHOSIS	EBF	Substantially Equivalent	Kerr Corporation	accessdata.fda.gov
May 11, 2009	K090826	MONOBOND PLUS	KLE	Substantially Equivalent	Ivoclar Vivadent, Inc.	accessdata.fda.gov
April 29, 2009	K090701	EMPRESS DIRECT	EBF	Substantially Equivalent	Ivoclar Vivadent, Inc.	accessdata.fda.gov
April 28, 2009	K083695	TRAXODENT	MVL	Substantially Equivalent	Premier Dental Products Co.	accessdata.fda.gov
January 21, 2009	K083652	IBOND TOTAL ETCH	KLE	Substantially Equivalent	Heraeus Kulzer,GmbH	accessdata.fda.gov
December 17, 2008	K083610	FILTEK SUPREME ULTRA UNIVERSAL RESTORATIVE	EBF	Substantially Equivalent	3M Company	accessdata.fda.gov
December 11, 2008	K082744	BEAUTIBOND	KLE	Substantially Equivalent	Shofu Dental Corp.	accessdata.fda.gov
October 21, 2008	K082768	G-BOND PLUS	KLE	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
June 19, 2008	K080940	ESTELITE SIGMA QUICK	EBF	Substantially Equivalent	Tokuyama Dental Corporation	accessdata.fda.gov
February 15, 2008	K073697	TRANSBOND SUPREME ADHESIVE	DYH	Substantially Equivalent	3M Unitek	accessdata.fda.gov
February 4, 2008	K073554	NEUN	EBF	Substantially Equivalent	Heraeus Kulzer,GmbH	accessdata.fda.gov
January 29, 2008	K073209	MAXCEM 2	MZW	Substantially Equivalent	Kerr Corporation	accessdata.fda.gov
August 15, 2007	K071742	BEAUTIFIL II	EBF	Substantially Equivalent	Shofu Dental Corp.	accessdata.fda.gov
July 19, 2007	K071288	MODIFICATION TO KAVO QUATTROCARE	EBF	Substantially Equivalent	Sybron Dental Specialties, Inc.	accessdata.fda.gov
June 7, 2007	K070723	FUTURABOND DC/SINGLE DOSE	KLE	Substantially Equivalent	Voco GmbH	accessdata.fda.gov
April 12, 2007	K070854	GC MI PASTE PLUS	EJR	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
March 29, 2007	K070698	COE COMFORT	EBI	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
March 29, 2007	K070697	COE SOFT	EBI	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
March 21, 2007	K070325	CLEARFIL MAJESTY ESTHETIC PLT	EBF	Substantially Equivalent	Kuraray Medical, Inc.	accessdata.fda.gov
July 14, 2006	K061535	GC XLC-100 CAPSULE	EMA	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
April 24, 2006	K060684	ADPER PROMPT, ADPER PROMPT L-POP	KLE	Substantially Equivalent	3M Espe AG Dental Products	accessdata.fda.gov
February 3, 2006	K053565	TEMPBOND CLEAR WITH TRICLOSAN	EMA	Substantially Equivalent	Sybron Dental Specialties, Inc.	accessdata.fda.gov
October 20, 2005	K052462	G-COAT	EBD	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
October 14, 2005	K051705	IPS E.MAX CAD/IPS E.MAX ZIRCAD	EIH	Substantially Equivalent	Ivoclar Vivadent, Inc.	accessdata.fda.gov
August 8, 2005	K051808	ESTELITE FLOW QUICK	EBF	Substantially Equivalent	Tokuyama Dental Corporation	accessdata.fda.gov
July 27, 2005	K051867	GRANDIO	EBF	Substantially Equivalent	Voco GmbH	accessdata.fda.gov
July 15, 2005	K051424	HYDROGUM 5	ELW	Substantially Equivalent	Zhermack S.P.A.	accessdata.fda.gov
June 28, 2005	K051535	MODIFICATION TO:REGISTRADO X-TRA	ELW	Substantially Equivalent	Voco GmbH	accessdata.fda.gov
April 22, 2005	K050880	DYRACT EXTRA RESTORATIVE	EBF	Substantially Equivalent	Dentsply Intl.	accessdata.fda.gov
February 11, 2005	K050180	EXPA-SYL	MVL	Substantially Equivalent	Produits Dentaires Pierre Rolland	accessdata.fda.gov
November 18, 2004	K042348	GRADIA DIRECT LOFLO	EBF	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
November 9, 2004	K042819	TETRIC EVOCERAM	EBF	Substantially Equivalent	Ivoclar Vivadent, Inc.	accessdata.fda.gov
June 29, 2004	K041471	G-BOND	KLE	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
June 16, 2004	K040906	CALIBRA CEMENT	EMA	Substantially Equivalent	Dentsply Intl.	accessdata.fda.gov
April 30, 2004	K040393	RIVA LUTING	EMA	Substantially Equivalent	Southern Dental Industries, Inc.	accessdata.fda.gov
April 22, 2004	K040567	GC INITIAL MC, AL AND LF	EIH	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
April 7, 2004	K040769	STRUCTUR 2 SC	EBG	Substantially Equivalent	Voco GmbH	accessdata.fda.gov
December 30, 2003	K033665	VENUS FLOW	EBF	Substantially Equivalent	Heraeus Kulzer, Inc.	accessdata.fda.gov
December 5, 2003	K033520	BLUEPHASE	EBZ	Substantially Equivalent	Ivoclar Vivadent, Inc.	accessdata.fda.gov
November 21, 2003	K033022	PROTEMP 3 GARANT	EBG	Substantially Equivalent	3M Espe AG Dental Products	accessdata.fda.gov

Compare with other makers

Updated December 9, 2021. 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.