Data / Medical devices / United States / Ortho-Clinical Diagnostics, Inc.

Ortho-Clinical Diagnostics, Inc.: FDA-registered device maker in Rochester, NY, United States, 35 510(k) clearances

Name: Ortho-Clinical Diagnostics, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Ortho-Clinical Diagnostics, Inc. is registered with the FDA (registration 1319809) in Rochester, NY, United States. It lists 50 device types. The FDA files 35 510(k) clearances under its listings, the newest dated August 13, 2021. 19 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this one Watch Ortho-Clinical Diagnostics, Inc.

FDA registration number: 1319809
FEI number: 1000305840
Address: 513 Technology Blvd., Rochester, NY, United States, 14626
Owner or operator: QuidelOrtho Corporation (2024674)
Roles: Manufacturer, Manufacturer for export
First device listed: December 15, 2022
Registered through: 2026
Brand names listed: VITROS 5600 Integrated System, VITROS 5600 Integrated System Certified, VITROS 5600 Integrated System Refurbished, VITROS A1c Slides, VITROS ACET Slides, VITROS ALB Slides, VITROS ALB-TP Slides, VITROS ALC Slides and more

Devices it lists

Device	Product code	Class	Role	Source
Acid, Lactic, Enzymatic Method	KHP	1	Manufacturer	accessdata.fda.gov
Acid, Uric, Uricase (Colorimetric)	KNK	1	Manufacturer	accessdata.fda.gov
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	JJE	1	Manufacturer	accessdata.fda.gov
Azo Dye, Calcium	CJY	2	Manufacturer	accessdata.fda.gov
Biuret (Colorimetric), Total Protein	CEK	2	Manufacturer	accessdata.fda.gov
Bromcresol Green Dye-Binding, Albumin	CIX	2	Manufacturer	accessdata.fda.gov
Bromcresol Purple Dye-Binding, Albumin	CJW	2	Manufacturer for export	accessdata.fda.gov
C-Reactive Protein, Antigen, Antiserum, And Control	DCK	2	Manufacturer	accessdata.fda.gov
Calibrator, Multi-Analyte Mixture	JIX	2	Manufacturer	accessdata.fda.gov
Calibrator, Primary	JIS	2	Manufacturer	accessdata.fda.gov
Calibrator, Secondary	JIT	2	Manufacturer	accessdata.fda.gov
Colorimetry, Acetaminophen	LDP	2	Manufacturer	accessdata.fda.gov
Colorimetry, Cholinesterase	DIH	1	Manufacturer	accessdata.fda.gov
Colorimetry, Salicylate	DKJ	2	Manufacturer	accessdata.fda.gov
Diazo Colorimetry, Bilirubin	CIG	2	Manufacturer	accessdata.fda.gov
Differential Rate Kinetic Method, Cpk Or Isoenzymes	JHS	2	Manufacturer	accessdata.fda.gov
Electrode, Ion Specific, Potassium	CEM	2	Manufacturer	accessdata.fda.gov
Electrode, Ion Specific, Sodium	JGS	2	Manufacturer	accessdata.fda.gov
Electrode, Ion-Specific, Chloride	CGZ	2	Manufacturer	accessdata.fda.gov
Enzymatic Esterase--Oxidase, Cholesterol	CHH	1	Manufacturer	accessdata.fda.gov
Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet	DMT	2	Manufacturer	accessdata.fda.gov
Enzymatic Method, Creatinine	JFY	2	Manufacturer	accessdata.fda.gov
Enzymatic, Carbon-Dioxide	KHS	2	Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Carbamazepine	KLT	2	Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Digitoxin	LFM	2	Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Diphenylhydantoin	DIP	2	Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Phenobarbital	DLZ	2	Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Theophylline	KLS	2	Manufacturer	accessdata.fda.gov
Flame Photometry, Lithium	JIH	2	Manufacturer	accessdata.fda.gov
Glucose Oxidase, Glucose	CGA	2	Manufacturer	accessdata.fda.gov
Hemoglobin A1c Test System	PDJ	2	Manufacturer for export	accessdata.fda.gov
Kinetic Method, Gamma-Glutamyl Transpeptidase	JQB	1	Manufacturer	accessdata.fda.gov
Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl	LBS	1	Manufacturer	accessdata.fda.gov
Ldl & Vldl Precipitation, Hdl	LBR	1	Manufacturer	accessdata.fda.gov
Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides	CDT	1	Manufacturer	accessdata.fda.gov
Lipase-Esterase, Enzymatic, Photometric, Lipase	CHI	1	Manufacturer	accessdata.fda.gov
Lowry (Colorimetric), Total Protein	JGP	2	Manufacturer	accessdata.fda.gov
Multi-Analyte Controls, All Kinds (Assayed)	JJY	1	Manufacturer	accessdata.fda.gov
Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase	CFJ	2	Manufacturer	accessdata.fda.gov
Nadh Oxidation/Nad Reduction, Alt/Sgpt	CKA	1	Manufacturer, Manufacturer for export	accessdata.fda.gov
Nadh Oxidation/Nad Reduction, Ast/Sgot	CIT	2	Manufacturer, Manufacturer for export	accessdata.fda.gov
Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes	CJE	2	Manufacturer	accessdata.fda.gov
Phosphomolybdate (Colorimetric), Inorganic Phosphorus	CEO	1	Manufacturer	accessdata.fda.gov
Photometric Method, Ammonia	JID	1	Manufacturer	accessdata.fda.gov
Photometric Method, Iron (Non-Heme)	JIY	1	Manufacturer	accessdata.fda.gov
Photometric Method, Magnesium	JGJ	1	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Thyroid-Stimulating Hormone	JLW	2	Manufacturer	accessdata.fda.gov
Single (Specified) Analyte Controls (Assayed And Unassayed)	JJX	1	Manufacturer	accessdata.fda.gov
Starch-Dye Bound Polymer, Amylase	CIW	2	Manufacturer	accessdata.fda.gov
Urease, Photometric, Urea Nitrogen	CDN	2	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
August 13, 2021	K210858	VITROS Chemistry Products PHBR Slides	DLZ	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.	accessdata.fda.gov
June 7, 2019	K191316	VITROS XT Chemistry Products ALB-TP Slides	CIX	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.	accessdata.fda.gov
April 26, 2019	K190807	VITROS XT Chemistry Products TBIL-ALKP Slides	CIG	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.	accessdata.fda.gov
April 3, 2019	K190520	VITROS XT Chemistry Products GLU-Ca Slides	CGA	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.	accessdata.fda.gov
March 27, 2019	K190490	VITROS XT Chemistry Products TRIG-CHOL Slides	CHH	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.	accessdata.fda.gov
March 14, 2019	K190326	VITROS XT Chemistry Products UREA-CREA Slides	CDN	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.	accessdata.fda.gov
October 30, 2018	K182072	VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides, VITROS Chemistry Products GLU Slides	CGZ	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.	accessdata.fda.gov
October 30, 2018	K182063	VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VITROS XT 7600 Integrated System	JFY	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.	accessdata.fda.gov
September 24, 2015	K152433	VITROS Chemistry Products CRP Slides; VITRO Chemistry Products Calibrator Kit 7	DCK	Substantially Equivalent	Ortho Clinical Diagnostics	accessdata.fda.gov
May 31, 2013	K130332	VITROS CHEMISTRY PRODUCTS TRIG SLIDES	CDT	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.	accessdata.fda.gov
September 7, 2012	K120609	VITROS CHEMISTRY PRODUCTS DHDL SLIDES	LBS	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.	accessdata.fda.gov
October 23, 2008	K081543	VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 5600 INTEGRATED SYSTEM	JLW	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.	accessdata.fda.gov
June 30, 2008	K081411	VITROS CHEMISTRY PRODUCT NA+ SLIDES; VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2	JGS	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.	accessdata.fda.gov
December 7, 2007	K073157	VITROS CHEMISTRY PRODUCTS K+ SLIDES AND CALIBRATOR KIT 2	CEM	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.	accessdata.fda.gov
September 20, 2007	K072440	VITROS CHEMISTRY PRODUCTS: CA SLIDES (MODEL: 145 0261), CALIBRATORS KIT 1 (MODEL: 188 2208)	CJY	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.	accessdata.fda.gov
October 28, 2004	K042006	VITROS CHEMISTRY PRODUCTS DHDL SLIDES, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 25, VITROS CHEMISTRY PRODUCTS PERFORMACE	LBS	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.	accessdata.fda.gov
December 10, 2002	K023876	VITROS CHEMISTRY PRODUCTS MG SLIDE, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1	JIX	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.	accessdata.fda.gov
December 10, 2002	K023875	VITROS CHEMISTRY PRODUCTS ALB SLIDE, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 4	CIX	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.	accessdata.fda.gov
August 30, 2001	K012593	VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2	LBR	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.	accessdata.fda.gov
July 20, 2000	K001885	VITROS CHEMISTRY PRODUCTS BUN/UREA SLIDES AND VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1	CDN	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.	accessdata.fda.gov
February 18, 1997	K964960	VITROS CHEMISTRY PRODUCTS UPRO SLIDES	JGP	Substantially Equivalent	Johnson & Johnson Clinical Diagnostics, Inc.	accessdata.fda.gov
December 18, 1995	K954933	EKTACHEM CLINICAL CHEMISTRY SLIDE FOR ACETAMINOPHEN	LDP	Substantially Equivalent	Johnson & Johnson Clinical Diagnostics, Inc.	accessdata.fda.gov
January 17, 1995	K946090	KODAK EKTACCHEM 950IRC ANALYZER	JJE	Substantially Equivalent	Clinical Diagnostic Systems, Inc.	accessdata.fda.gov
October 20, 1994	K942610	KODAK EXTACHEM CLINICAL CHEMISTRY SLIDE DIGOXIN (DGXN)	LFM	Substantially Equivalent	Eastman Kodak Company	accessdata.fda.gov
March 21, 1994	K934273	KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE ALCOHOL (ALC)	DMT	Substantially Equivalent	Eastman Kodak Company	accessdata.fda.gov
August 3, 1993	K932729	KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (PHOS)	CEO	Substantially Equivalent	Eastman Kodak Company	accessdata.fda.gov
January 26, 1993	K924488	KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (LI)	JIH	Substantially Equivalent	Eastman Kodak Company	accessdata.fda.gov
February 4, 1991	K910143	KODAK EXTACHEM CLINICAL CHEMISTRY SLIDES (FE)	JIY	Substantially Equivalent	Eastman Kodak Company	accessdata.fda.gov
July 16, 1990	K902356	KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (SALI)	DKJ	Substantially Equivalent	Eastman Kodak Company	accessdata.fda.gov
June 27, 1986	K861387	KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (CK-MB)	JHS	Substantially Equivalent	Eastman Kodak Company	accessdata.fda.gov
May 29, 1986	K861367	KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (THEO)	KLS	Substantially Equivalent	Eastman Kodak Company	accessdata.fda.gov
April 4, 1984	K840606	EKTACHEM CLINICAL CHEM. SLIDES	CIG	Substantially Equivalent	Eastman Kodak Company	accessdata.fda.gov
April 1, 1982	K820723	KODAK EKTACHEM CLINICAL CHEM. NH3	JID	Substantially Equivalent	Eastman Kodak Company	accessdata.fda.gov
August 3, 1981	K812027	KODAK EKTACHEM CLIN. CHEM. SLIDES (AMYL)	CIW	Substantially Equivalent	Eastman Kodak Company	accessdata.fda.gov
August 20, 1980	K801649	KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES	KNK	Substantially Equivalent	Eastman Kodak Company	accessdata.fda.gov

Recalls

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

Initiated	Event	Class	Status	Product	Reason	Source
December 19, 2024	96031	Class II	Ongoing	Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalog Number: 6802413 (New), 6802415 (Certified/Refurbished), 6904001 (China) Software Version: version 3.8.0 or higher Product Description: In vitro	The VITROS 5600 Integrated System software versions 3.8.0 may not correctly notify users if the Signal Reagent Pack exceeds the on-board and/or shelf-life expiration date. This could result in the use of expired products, which would increase the risk of no results or erroneous results from the instrument.	accessdata.fda.gov
October 25, 2023	93378	Class II	Ongoing	VITROS Chemistry Products ECO2 Slides-For in vitro diagnostic use only. VITROS Chemistry Products ECO2 Slides quantitatively measure total carbon dioxide (CO2) concentration in serum and plasma using VITROS 250/350/5,1 F	Ortho Clinical Diagnostics (QuidelOrtho) confirmed during routine testing that some lots from Coating 3598 of VITROS ECO2 slides included carts which may contain consecutive slides that may not function as intended. These affected slides (potentially intermittent, consecutive slides within a cart or across consecutive carts) have an abnormality which may cau	accessdata.fda.gov
September 12, 2023	93238	Class II	Ongoing	VITROS Chemistry Products Lipase Slides, Product Codes 1668409 (contains 60 Slides per Cartridge) and 8297749 (contains 18 slides per cartridge)	Products 1668409 and 8297749 may contain VITROS Lipase Slides with an abnormality which could cause -46% to +86% bias in lipase results depending on how the slides are used. Falsely low levels could result in a missed or delayed diagnosis of acute pancreatitis and may lead to diagnostic confusion in the setting of acute abdominal symptoms. Falsely elevated l	accessdata.fda.gov
August 5, 2023	92928	Class II	Ongoing	VITROS XT Chemistry Products TBIL-ALKP Slides	Samples containing high levels of ALKP (or an interfering substance) could deplete the available substrate in the reagent layer of a VITROS ALKP Slide and not post the substrate deleption (DP) code, which may result in the System reporting an incorrect value (lower than the actual value), which may result in missed or delayed diagnosis of liver disease.	accessdata.fda.gov
May 3, 2021	87888	Class II	Terminated	VITROS CoV2 Ag calibrator (Product Code 6199950) - Product Usage: is a chemiluminescent immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens in nasopharyngeal (NP) and anterior n	Ortho investigated and confirmed the potential for unexpected failed calibration, and condition codes associated with the calibration, when using VITROS SARS-CoV-2 Ag Reagent Pack along with VITROS Immunodiagnostic Products SARS-CoV-2 Ag Calibrator, Lot 20.	accessdata.fda.gov
March 26, 2021	87649	Class II	Terminated	VITROS Black Reference Slides CATALOG #: J02316 - Product Usage: The Black Reference Slide is a part/ tool used in the reflectometer correction factor adjustment procedure.	Delayed results. Ortho confirmed that two lots of VITROS Black Reference Slides are incorrectly labelled as White Reference Slides. If the customer fails to notice both the product name or the unexpected color of the slides and tries to use Black Reference Slides as White Reference Slides, the Correction Factor test will fail - and the analyzer will not be a	accessdata.fda.gov
July 13, 2020	86070	Class II	Terminated	VITROS Chemistry Products TBIL Slides- 5 PACK/300 SLDS In vitro Diagnostic quantitatively measure total bilirubin (TBIL) concentration in serum and plasma, Product code: 8159931	Etrombopag Interference for VITROS Chemistry Products: TBIL Slides, VITROS BuBc Slides and VITROS XT TBIL-ALKP Slides	accessdata.fda.gov
May 11, 2020	85652	Class II	Terminated	VITROS Chemistry Product AMYL Slides Reagent, AMYLASE/5 PACK/300 SLDS, Product Code 1202670, UDI # 10758750008513 - Product Usage: For in vitro diagnostic use only to quantitatively measure amylase activity in serum, pla	Multiple coatings of VITROS Chemistry Products AMYL Slides are showing imprecision on control fluids when compared to the expected within lab SD as listed on the Performance Verifier (PV) Assay Sheets.	accessdata.fda.gov
April 1, 2020	85363	Class II	Terminated	VITROS Chemistry Products CKMB Slides, Creatine Kinase MB, Product Code 805 8232-300 slides, UDI Number 10758750004294 - Product Usage: The VITROS Chemistry Product Slides are used to measure creatine kinase MB (CK-MB) a	The Spanish and Swedish language versions of the IFU state that the assay can be tested with Plasma which is false and could result in biased results.	accessdata.fda.gov
September 10, 2019	83879	Class II	Terminated	VITROS chemistry Products Cl- Slides, Catalog No. 6844471 (which supports Urine CL-). MicroSlides which contain reagents in a dry, multi-layered form.	Users may experience intermittent slide dispense issues with some cartridges due to the anti-backup platen failing to advance inside the cartridge.	accessdata.fda.gov
June 17, 2019	83228	Class II	Terminated	VITROS Chemistry Products GLU Slides-Product Code:1707801. IVD VITROS Chemistry Products GLU Slides quantitatively measure glucose (GLU) concentration in serum, plasma, urine, and cerebrospinal fluid using VITROS 250/350	Potentially Biased Results using VITROS Chemistry Products GLU Slides	accessdata.fda.gov
May 5, 2018	80436	Class II	Terminated	VITROS Sodium Slides, Catalog #	Potential for positively biased results	accessdata.fda.gov
June 12, 2017	77613	Class II	Terminated	VITROS Chemistry Products PHYT Slides, REF/CATALOG, Rx ONLY, IVD; Ortho-Clinical Diagnostics, Inc. For in vitro diagnostic use only. VITROS Chemistry Products PHYT Slides quantitatively measure phenytoin (PHYT) concentra	The firm identified the potential for biased results to be generated when processing VITROS PHYT Slide product with citrate plasma specimen samples. The current Instructions for Use (IFU) and Assay Summary Chart state serum, heparin plasma, and citrate plasma as acceptable specimen types for use with the PHYT assay.	accessdata.fda.gov
December 20, 2016	76119	Class II	Terminated	VITROS Na+ Slides, (UPN 10758750004812) For in vitro diagnostic use only. VITROS Na+ Slides quantitatively measure sodium (Na+) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry	There is a potential for biased results to be generated over the 10 day on-analyzer storage limit when using VITROS Na+ Slide cartridges warmed at room temperature and loaded onto the analyzer after using the minimum warm up requirements stated in the IFU. If Quality Control (QC) results are within acceptable limits, reported results are acceptable and were	accessdata.fda.gov
December 8, 2016	75936	Class II	Terminated	VITROS Chemistry Products UPRO Slides, UPN 10758750000593, Product Usage: Quantitative measurement of total protein concentration in urine.	There is a potential for variable negatively and positively biased urine protein results using VITROS UPRO Slides.	accessdata.fda.gov
October 26, 2016	75692	Class III	Terminated	VITROS CRP Slides: 1) VITROS Chemistry Products CRP Slides (250 slides per sales unit), Catalog # 1926740 and 2), VITROS Chemistry Products CRP Slides (90 slides per sales unit), Catalog # 1926740	CRP samples diluted using VITROS Chemistry Products Specialty Diluent, VITROS Chemistry Products FS Diluent Pack 3, or a sample with a low concentration of CRP had positively biased results if the endogenous level of CRP in the diluent is not subtracted from the final result. The IFUs do not provide specific instructions for how to account for endogenous CRP	accessdata.fda.gov
May 18, 2016	74355	Class II	Terminated	VITROS Chemistry Products Ca Slides, GEN 29, REF/Product Code, Unique Device Identifier No. 10758750009114 or 20758750009111, IVD -- Sales Unit: 300 slides/pack Product Usage: For in vitro diagnostic use only. VITROS Ca	Ortho Clinical Diagnostics (OCD) confirmed a potential for biased calcium (Ca) results to be generated when using VITROS Ca Slides, GEN29, and the VITROS 250/350/950/5,1 FS, 4600 Chemistry System or the VITROS 5600 Integrated System. An increase in negatively biased calcium results complaints prompted the investigation that identified this product issue.	accessdata.fda.gov
November 6, 2014	69791	Class II	Terminated	VITROS CHEMISTRY PRODUCTS TRIG Slides, REF, IVD For in vitro diagnostic use only. VITROS Chemistry Products TRIG Slides quantitatively measure triglyceride (TRIG) concentration in serum and plasma using VITROS 250/350/95	Potential for biased results using the specific lot of VITROS CHEMISTRY PRODUCTS TRIG slides.	accessdata.fda.gov
August 20, 2014	69094	Class II	Terminated	VITROS Chemistry Products PHYT (Phenytoin) Slides, REF/Product Code, IVD. For in vitro diagnostic use only. VITROS Chemistry Products PHYT Slides quantitatively measure phenytoin (PHYT) concentration in serum and plasma	Ortho Clinical Diagnostics identified a potential for biased results to be generated when using VITROS PHYT Slides, Lot 2613-0150-4913. Some positively biased results were identified during testing of a different VITROS PHYT Slide lot; the affected slides were not released for distribution. Since Lot 2613-0150-4913 was manufactured in the same event, there i	accessdata.fda.gov

Compare with other makers

Updated January 21, 2025. 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.