Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
35521–35544 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 25, 2015
Short SureLock All-Suture Anchor, 1.4mm with (1) size 0 UHMWPE suture with...
K143473 · MBI
Cayenne Medical, Inc.
Orthopedic · 110d
Cleared Mar 25, 2015
FIBERGRAFT BG PUTTY BONE GRAFT SUBSTITUTE
K143533 · MQV
Prosidyan, Inc.
Orthopedic · 103d
Cleared Mar 25, 2015
Echo Bi-Metric Microplasty Line Extension
K150503 · LPH
Biomet, Inc.
Orthopedic · 27d
Cleared Mar 25, 2015
ebb Complete Tamponade System
K150573 · OQY
Clinical Innovations, LLC
Obstetrics & Gynecology · 19d
Cleared Mar 24, 2015
MAGEC SPINAL BRACING AND DISTRACTION SYSTEM
K141278 · PGN
Ellipse Technologies, Inc.
Orthopedic · 312d
Cleared Mar 24, 2015
VARIANT II TURBO HbA1c Kit - 2.0
K142448 · PDJ
Bio-Rad Laboratories, Inc.
Chemistry · 203d
Cleared Mar 24, 2015
Progressive Orthopedic Total Knee System
K142649 · JWH
The Progressive Orthopaedic Company, LLC
Orthopedic · 188d
Cleared Mar 24, 2015
MiniStim MS-IVB Peripheral Nerve Stimulator
K143095 · BXN
Halyard Health, Inc.
Anesthesiology · 147d
Cleared Mar 24, 2015
SL-PLUS MIA and SL-PLUS Femoral Stems with Ti/HA
K143096 · LZO
Smith & Nephew, Inc.
Orthopedic · 147d
Cleared Mar 24, 2015
Fluidshield* Surgical Mask with Expanded Chamber
K143287 · FXX
Halyard Health, Inc.
General Hospital · 127d
Cleared Mar 24, 2015
Customer Remote Console (CRC)
K150193 · LLZ
Ge Medical Systems, LLC
Radiology · 55d
Cleared Mar 24, 2015
Tarsa-Link Wedge Fixation System
K150368 · HRS
Life Spine
Orthopedic · 40d
Cleared Mar 23, 2015
BIOGEL PS SURGICAL GLOVE SERIES, BIOGEL SKINSENSE SURGICAL GLOVE SERIES
K140477 · KGO
Molnlycke Health Care Us, LLC
General Hospital · 390d
Cleared Mar 23, 2015
IBS IMPLANT SYSTEM
K140806 · DZE
Innobiosurg Co., Ltd.
Dental · 356d
Cleared Mar 23, 2015
LUOFUCON SILVER PU ANTIBACTERIAL FOAM DRESSING
K140954 · FRO
Huizhou Foryou Medical Devices Co., Ltd.
General & Plastic Surgery · 343d
Cleared Mar 23, 2015
SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA EXCHANGE SET (DISPOSABLE BLOOD...
K141938 · LKN
Terumobct, Inc.
Gastroenterology & Urology · 249d
Cleared Mar 23, 2015
BioniCare Hand System
K142236 · NYN
Vision Quest Industries, Inc.
Neurology · 222d
Cleared Mar 23, 2015
BigEasy Non-Rebreathing Valve
K142402 · CBP
12th Man Technologies, Inc.
Anesthesiology · 208d
Cleared Mar 23, 2015
Flow-Screw
K142776 · HWC
Flow-Fx, LLC
Orthopedic · 178d
Cleared Mar 23, 2015
Stryker CMF MEDPOR Customized Implant
K143173 · FWP
Stryker
General & Plastic Surgery · 139d
Cleared Mar 23, 2015
Revitive IX (OTC)
K143207 · NGX
Actegy , Ltd.
Physical Medicine · 136d
Cleared Mar 23, 2015
Depuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm Plates...
K150099 · HRS
Synthes USA Products, LLC
Orthopedic · 62d
Cleared Mar 23, 2015
Integra Laminoplasty System
K150469 · NQW
Seaspine, Inc.
Orthopedic · 28d
Cleared Mar 20, 2015
SUMMED HIGH PRESSURE LINE
K140356 · DQO
Sunny Medical Device (Shenzhen) Co.,...
Cardiovascular · 401d