Know about competitor clearances and recalls the day they post

Every new 510(k) clearance and device recall in your specialty, with review times, recall reasons and an advisory-opportunity score, from official FDA data.

Long-tail intelligence feed for MedTech regulatory and QA consulting firms, contract manufacturers and specialty device distributors

LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Mon, 26 Oct 2026 16:50:53 GMT

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Predicate Speed & CAPA Advisory Opportunity Score is a heuristic estimate, not advice.

Latest top-scored records

Record	Specialty	Type	Date
Class I recall Z-3228-2026: Medline Industries, LP	Other	Class I	2026-10-07
Class I recall Z-3227-2026: Medline Industries, LP	Other	Class I	2026-10-07
Class I recall Z-3252-2026: Draeger, Inc.	Other	Class I	2026-10-07
Class I recall Z-3140-2026: CooperSurgical, Inc.	Other	Class I	2026-09-30
Class II recall Z-3155-2026: Philips North America Llc	Other	Class II	2026-10-07
Class II recall Z-0085-2027: Stryker Sustainability Solutions	Other	Class II	2026-10-14
Class II recall Z-0088-2027: Medtronic MiniMed, Inc.	Other	Class II	2026-10-14
Class II recall Z-0089-2027: Nihon Kohden America LLC	Other	Class II	2026-10-14
Class II recall Z-0083-2027: Beckman Coulter Inc.	Other	Class II	2026-10-14
Class II recall Z-0108-2027: Canon Medical System, USA, INC.	Other	Class II	2026-10-14
Class II recall Z-0084-2027: Beckman Coulter Inc.	Other	Class II	2026-10-14
Class II recall Z-0087-2027: Medline Industries, LP	Other	Class II	2026-10-14
Class II recall Z-0086-2027: Medline Industries, LP	Other	Class II	2026-10-14
Class II recall Z-0079-2027: Cardinal Health 200, LLC	Other	Class II	2026-10-14
Class II recall Z-0078-2027: PHILIPS MEDICAL SYSTEMS	Other	Class II	2026-10-14
Class II recall Z-0117-2027: LeMaitre Vascular, Inc.	Other	Class II	2026-10-14
Class II recall Z-0077-2027: GRI Medical & Electronic Technology Co., Ltd.	Other	Class II	2026-10-14
Class II recall Z-0119-2027: Intellijoint Surgical, Inc.	Other	Class II	2026-10-14
Class II recall Z-0081-2027: Safeguard US Operating LLC	Other	Class II	2026-10-14
Class II recall Z-0091-2027: Onkos Surgical, Inc.	Other	Class II	2026-10-14
Class II recall Z-0080-2027: Limitless Cryo Spa LLC	Other	Class II	2026-10-14
Class II recall Z-0090-2027: Onkos Surgical, Inc.	Other	Class II	2026-10-14
Class II recall Z-0082-2027: DRG International, Inc.	Other	Class II	2026-10-14
Class II recall Z-0107-2027: POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC	Other	Class II	2026-10-14
Class II recall Z-0074-2027: Steris Corporation	Other	Class II	2026-10-14

Browse by record type

510(k) clearances (300) Class II device recalls (186) Class III device recalls (10) Class I device recalls (4)

Browse by specialty

Radiology (44) Orthopedic (40) Cardiovascular (39) General & Plastic Surgery (31) Dental (22) Gastroenterology & Urology (22) Neurology (14) Microbiology (14) Anesthesiology (10) Clinical Chemistry (9) General Hospital (8) Obstetrics & Gynecology (8) Ophthalmic (4)

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Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.