FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
11593–11616 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 20, 2022
Al Smile Aligner
K222308 · NXC
Nanjing Jiahe Dental Technology Co.,...
Dental · 141d
Cleared Dec 20, 2022
Indigo Aspiration System - Lightning Flash
K222358 · QEW
Penumbra, Inc.
Cardiovascular · 138d
Cleared Dec 20, 2022
Smart SPACE Shoulder Planner and 3D Positioners
K222405 · QHE
Lima Corporate S.P.A.
Orthopedic · 133d
Cleared Dec 20, 2022
Penumbra System (Reperfusion Catheter RED 43)
K222808 · NRY
Penumbra, Inc.
Neurology · 95d
Cleared Dec 20, 2022
AirRay
K222896 · IZL
Poskom Co., Ltd.
Radiology · 88d
Cleared Dec 20, 2022
AEON-C™ Stand Alone System
K223140 · OVE
Dio Medical, Inc.
Orthopedic · 77d
Cleared Dec 20, 2022
SpineJack® Expansion Kit
K223294 · NDN
Stryker Instruments
Orthopedic · 55d
Cleared Dec 19, 2022
MARVEL™ Growing Rods
K213196 · PGM
Globus Medical, Inc.
Orthopedic · 446d
Cleared Dec 19, 2022
4CIS BLACK MARLIN PLIF CAGE SYSTEM, 4CIS DOLPHIN TLIF CAGE SYSTEM
K213653 · MAX
Solco Biomedical Company India...
Orthopedic · 395d
Cleared Dec 19, 2022
EsCem
K214076 · EMA
Spident Co., Ltd.
Dental · 357d
Cleared Dec 19, 2022
Mechanical Guidewire
K221351 · DQX
Baylis Medical Company, Inc.
Cardiovascular · 223d
Cleared Dec 19, 2022
BreathID Hp System
K221896 · MSQ
Meridian Bioscience Israel , Ltd.
Microbiology · 172d
Cleared Dec 19, 2022
Pulse Oximeter (UC-200, UC-201, UC-202, UC-203, UC-204, UC-100, UC-101,...
K222213 · DQA
Unimed Medical Supplies, Inc.
Anesthesiology · 147d
Cleared Dec 19, 2022
ViewFlex Xtra Reprocessed ICE Catheter
K222217 · OWQ
Abbott Medical
Cardiovascular · 147d
Cleared Dec 19, 2022
GORE® ENFORM Biomaterial
K222919 · OXF
W. L. Gore and Associates, Inc.
General & Plastic Surgery · 84d
Cleared Dec 18, 2022
INOUE BALLOON A
K220881 · OZT
Toray Industries, Inc.
Cardiovascular · 268d
Cleared Dec 16, 2022
CardioPhase® hsCRP
K212559 · NQD
Siemens Healthcare Diagnostics...
Chemistry · 490d
Cleared Dec 16, 2022
AUXILOCK PEEK OPTIMA Screw-In Suture Anchor, AUXILOCK ROTADOR PEEK OPTIMA...
K213110 · MBI
Auxein Medical Private Limited
Orthopedic · 448d
Cleared Dec 16, 2022
Surgical Mask
K213601 · FXX
Wuhan Zonsen Medical Products Co., Ltd.
General Hospital · 396d
Cleared Dec 16, 2022
Oximeter (Model: JZK-301,JZK-303,JZK-305,JZK-307)
K213984 · DQA
Shenzhen Zhengkang Technology Co., Ltd.
Anesthesiology · 361d
Cleared Dec 16, 2022
Daylily Single Use Sterile Embryo Transfer Catheter
K220010 · MQF
Shanghai Horizon Medical Technology...
Obstetrics & Gynecology · 346d
Cleared Dec 16, 2022
Wellead Ureteral Catheter
K220036 · KOD
Well Lead Medical Co., Ltd.
Gastroenterology & Urology · 345d
Cleared Dec 16, 2022
Copan FecalSwab Collection, Transport and Preservation System
K220052 · JSM
Copan Italia Spa
Microbiology · 344d
Cleared Dec 16, 2022
multiFiltratePRO System
K220281 · KDI
Fresenius Medical Care Renal...
Gastroenterology & Urology · 318d