FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

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174,955 results
11329–11352 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Dec 16, 2022
Caduceus S
K220554 · SBF
Taiwan Main Orthopaedic Biotechnology...
Orthopedic · 291d
Cleared Dec 16, 2022
Overjet Calculus Assist
K220928 · MYN
Overjet, Inc.
Radiology · 260d
Cleared Dec 16, 2022
Saige-Density
K222275 · QIH
DeepHealth, Inc.
Radiology · 140d
Cleared Dec 16, 2022
KLICK (VARIANTS: POWER, RACE, MONSTER)
K222502 · ITI
Klaxon Mobility GmbH
Physical Medicine · 120d
Cleared Dec 16, 2022
Tuttnauer Pre-vacuum Steam Sterilizer models 3870HSG and 3870HSG-WS
K222608 · FLE
Tuttnauer , Ltd.
General Hospital · 109d
Cleared Dec 16, 2022
Rejoni Intrauterine Catheter
K222798 · LKF
Rejoni, Inc.
Obstetrics & Gynecology · 91d
Cleared Dec 16, 2022
BRM TOOL Screws, BIOPLAN Subtalar Implant
K222820 · HWC
Brm Extremities
Orthopedic · 88d
Cleared Dec 16, 2022
Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface Technology
K223153 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 71d
Cleared Dec 16, 2022
Phantom Metatarsal Shortening System
K223184 · HWC
Paragon 28, Inc.
Orthopedic · 65d
Cleared Dec 16, 2022
SofWave System
K223237 · OHV
Sofwave Medical, Ltd.
General & Plastic Surgery · 58d
Cleared Dec 16, 2022
BD Microtainer® Contact-Activated Lancets
K223243 · FMK
Becton, Dickinson and Company
General & Plastic Surgery · 57d