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
41329–41352 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 07, 2013
PROTEUS PATCH, INGESTIBLE SENSOR (ACCESSORY)
K131009 · OZW
Proteus Digital Health, Inc.
Gastroenterology & Urology · 26d
Cleared May 06, 2013
ORTHOCOR ACTIVE DEVICE ORTHOCOR GENERAL USE ACTIVE DEVICE
K121702 · ILX
Orthocor Medical
Physical Medicine · 332d
Cleared May 06, 2013
MODEL NUMBER: RMS1-2604, RMS1-2614, RMS1-2404, RMS1-2414, RMS2-2604,...
K122404 · FPA
Repro-Med Systems, Inc. Dba Rms...
General Hospital · 272d
Cleared May 06, 2013
EMPI PHOENIX
K124016 · IPF
Djo, LLC
Physical Medicine · 130d
Cleared May 06, 2013
LIQUICHEK PEDIATRIC CONTROL, LEVEL 1
K130963 · JJY
Bio-Rad Laboratories, Inc.
Chemistry · 28d
Cleared May 03, 2013
REVOIS PRO IMPLANT STSYEM
K113539 · DZE
Riemser Arzneimittel AG
Dental · 520d
Cleared May 03, 2013
KOMPREDA
K120597 · MRW
Custom Spine, Inc.
Orthopedic · 430d
Cleared May 03, 2013
ULTRASONIC BIOMETER FOR OPHTHALMOLOGY ULTRASONIC PACHYMETER
K121243 · IYO
MEDA Co., Ltd.
Radiology · 373d
Cleared May 03, 2013
SOLOPATH RE-COLLAPSIBLE ACCESS SYSTEM
K121404 · DYB
Onset Medical Corporation
Cardiovascular · 358d
Cleared May 03, 2013
ARTIGLASS L. O.R. GLASS SYRINGE
K122416 · FMF
Artiglass Srl
General Hospital · 268d
Cleared May 03, 2013
NEO PS KNEE SYSTEM
K122500 · JWH
Pipeline Orthopedics
Orthopedic · 260d
Cleared May 03, 2013
BIODENTA DENTAL IMPLANT SYSTEM - ABUTMENTS
K122559 · NHA
Biodenta Swiss AG
Dental · 254d
Cleared May 03, 2013
AG GUFFILL
K122721 · BSK
Hospitech Respiration , Ltd.
Anesthesiology · 240d
Cleared May 03, 2013
SMITH & NEWPHEW, INC. DISPOSABLE KNEE INSTRUMENTS
K123159 · JWH
Smith & Nephew, Inc.
Orthopedic · 206d
Cleared May 03, 2013
TRIATHLON TRITANIUM TIBIAL BASEPLATE
K123486 · MBH
Stryker
Orthopedic · 171d
Cleared May 03, 2013
DIGITAL BLOOD PRESSURE MONITOR
K123600 · DXN
Little Doctor Electronic...
Cardiovascular · 163d
Cleared May 03, 2013
METASURG NITINOL STAPLE IMPLANT
K123926 · JDR
Metasurg
Orthopedic · 134d
Cleared May 03, 2013
MILESTONE REVISION KNEE SYSTEM (MRKS) - FEMORAL COMPONENT, TIBIAL BASEPLATE,...
K130084 · JWH
Tgm Medical, Inc.
Orthopedic · 109d
Cleared May 03, 2013
ANATOMIC ANKLE ARTHRODESIS INTERLOCKING NAIL (A3 INTERLOCKING NAIL)
K130147 · HSB
Small Bone Innovations, Inc.
Orthopedic · 101d
Cleared May 03, 2013
QYAG LASER SYSTEM
K130250 · GEX
Palomar Medical Technologies, Inc.
General & Plastic Surgery · 91d
Cleared May 03, 2013
HOFFMANN LRF (LIMB RECONSTRUCTION FRAME SYSTEM)
K130334 · KTT
Stryker Trauma AG
Orthopedic · 81d
Cleared May 03, 2013
KNOTLESS FIBERTAK SUTURE ANCHOR
K130458 · MBI
Arthrex, Inc.
Orthopedic · 70d
Cleared May 03, 2013
ENSITE VELOCITY SYSTEM
K130594 · DQK
St Jude Medical
Cardiovascular · 57d
Cleared May 03, 2013
STERISPINE PS PEDICLE SCREW
K130632 · NKB
Safe Orthopaedics
Orthopedic · 56d