[ LIVE INTELLIGENCE · DEVICE MARKET ENTRY ]
What’s entering the US device market
6,000
510(K) CLEARANCES · 83 PMA ORIGINALS · LATEST 2026-07-17
FDA device decisions (openFDA 510(k) and PMA files, updated daily on a posting lag — recent weeks are incomplete). A 510(k) clearance finds substantial equivalence to a device already on the market; a PMA approval is an independent safety‑and‑effectiveness determination for high‑risk devices. Neither is an FDA endorsement, and the pathway reflects the device’s risk class, not the applicant’s quality. Most PMA records are supplements — changes to devices already approved.
TWO PATHS TO MARKET
510(K)Clearance — FDA agrees the device is substantially equivalent to one already on the market. The common path for moderate-risk devices.
PMAApproval — FDA independently finds reasonable assurance of safety and effectiveness. The stringent path for high-risk Class III devices.
83
83 ORIGINALS · 4,457 SUPPLEMENTS
Different evidentiary bars for different risk classes — not a quality ranking of devices or firms.
DECISIONS BY MONTH · 510(K) + PMA
510(K)PMA ORIGINAL
* current month — openFDA posts decisions on a lag, so recent months fill in for weeks.
BY MEDICAL SPECIALTY · PMA OVERLAID
General, Plastic Surgery945
Gastroenterology, Urology758
RECENT MARKET AUTHORIZATIONS
2026-07-17
Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG)
ABBOTT MEDICAL · Neurology
PMAP140009 SS134
2026-07-17
SportSuite Vision Software
Stryker Endoscopy · Unknown
510(K)DEN250040
2026-07-17
Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG)
ABBOTT MEDICAL · Neurology
PMAP010032 SS255
2026-07-17
Edwards SAPIEN 3 Pulmonic Delivery System: 9630PL29
Edwards Lifesciences, LLC · Cardiovascular
PMAP200015 SS069
2026-07-17
AssureTech Quick Cup Tests;AssureTech Multi-drug Urine Test Cup
Assure Tech., LLC · Clinical Toxicology
510(K)K261984
2026-07-17
Diode laser hair removal machine (QDTM-04)
Beijing Nubway S&T Co., Ltd. · General, Plastic Surgery
510(K)K261693
2026-07-17
Drivewire 35 Guidewire
Rapid Medical Ltd. · Cardiovascular
510(K)K254006
2026-07-17
Edwards Crimper: 9600CR
Edwards Lifesciences, LLC · Cardiovascular
PMAP140031 SS192
2026-07-17
LED LCD Monitor (OEV-271H)
Lg Electronics.Inc · Gastroenterology, Urology
510(K)K261614
2026-07-17
Natural Cycles
Natural Cycles Nordic AB · Obstetrics/Gynecology
510(K)K253694
2026-07-17
LoFric Origo Pro Coudé
Wellspect AB · Gastroenterology, Urology
510(K)K261658
2026-07-17
Dental Zirconia Blank & Coloring Liquid
Hunan Qinghao Puzhong Technology Co., Ltd. · Dental
510(K)K261046
2026-07-17
Catalyft PL Expandable Interbody System
Medtronic Sofamor Danek USA, Inc. · Orthopedic
510(K)K253011
2026-07-17
Cubresa BrainPET
Cubresa, Inc. · Radiology
510(K)K253963
2026-07-17
ZEISS CLINIC 360
Carl Zeiss Meditec, AG · Radiology
510(K)K260694
2026-07-17
Virasight
Virasoft Corporation · Pathology
510(K)K251952
2026-07-17
BIOFIRE® FILMARRAY® Tropical Fever Panel Control Kit
Biofire Defense, LLC · Microbiology
510(K)K261475
2026-07-17
CHZL Red Light Therapy Hair Growth Cap (Model(s):CHZL-120BK-L52D,CHZL-120BK-L53D,CHZL-120BK-L54D)
Shenzhen Chuanghong Zhilian Technology Co., Ltd. · Physical Medicine
510(K)K261675
2026-07-17
Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero® -C Cervical Cage System; AVS® Anchor-C Cervical Cage System; AVS® TL PEEK Spacer; AVS® PL PEEK Spacers; AVS® Navigator PEEK Spacer; AVS® AS PEEK Spacer; Monterey AL Interbody System; Aleutian IBF System; Cascadia Interbody System; Chesapeake Stabilization System; Sahara Stabilization System;
Stryker Spine · Orthopedic
510(K)K262061
2026-07-16
TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFR-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFL-SHB );TriMed Non-Spanning Wrist Fusion Plates (NSFR-SHB )
TriMed, Inc. · Orthopedic
510(K)K262032
SESE = “substantially equivalent” — the standard 510(k) clearance decision. Every row is a market authorization, not an FDA endorsement.
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