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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
69313–69336 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 05, 2004
RESCAN
K034033 · BZD
Resmed, Ltd.
Anesthesiology · 128d
Cleared May 05, 2004
DYMEDIX REUSABLE AIRFLOW/SNORE SENSOR
K040069 · MNR
Dymedix, Inc.
Anesthesiology · 112d
Cleared May 05, 2004
KENDALL EPUMP ENTERAL FEEDING PUMP AND ENTERAL FEEDING SETS
K040196 · LZH
Tyco Healthcare/Kendall
General Hospital · 97d
Cleared May 05, 2004
TRIATHLON CRUCIATE RETAINING (CR) TOTAL KNEE
K040267 · JWH
Howmedica Osteonics Corp.
Orthopedic · 90d
Cleared May 05, 2004
DEPUY PRESERVATION UNICONDYLAR TIBIA
K040268 · HRY
DePuy Orthopaedics, Inc.
Orthopedic · 90d
Cleared May 05, 2004
LASERPRO DIODE LASER SYSTEMS, MODELS 810, 940 & 980
K040294 · GEX
Photo Medex, Inc.
General & Plastic Surgery · 89d
Cleared May 05, 2004
GREENLIGHT 300
K040410 · DXN
A C Cossor & Son (Surgical) Limited
Cardiovascular · 77d
Cleared May 05, 2004
FLEXIFIL SERIES HC431 FULL FACE MASK, MODEL HC431A
K040506 · BZD
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 68d
Cleared May 05, 2004
MODIFICATION TO VERTE-STACK SPINAL SYSTEM
K040536 · MQP
Medtronic Sofamor Danek
Orthopedic · 64d
Cleared May 05, 2004
ACCU-STAT HOME DRUG TEST FOR MARIJUANA, COCAINE, AMPHETAMINE,...
K040629 · LDJ
Accu-Stat Diagnostics, Inc.
Toxicology · 56d
Cleared May 05, 2004
ULTRACINCH ABLATION DEVICE, ULTRACINCH ACCESSORY PACK, MODELS UC-8, UC-9,...
K040641 · NTB
Epicor Medical, Inc.
General & Plastic Surgery · 56d
Cleared May 05, 2004
INTUITIVE SURGICAL ENDOPASS ENDOSCOPIC DELIVERY INSTRUMENT, MODEL P/N 400170
K040948 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 23d
Cleared May 05, 2004
LORENZ SELF-DRILLING IMF SCREW
K040983 · DZE
Walter Lorenz Surgical, Inc.
Dental · 20d
Cleared May 05, 2004
REMSTAR AUTO WITH C-FLEX CPAP SYSTEM
K041010 · BZD
Respironics, Inc.
Anesthesiology · 15d
Cleared May 04, 2004
KING LTS REUSABLE OROPHARYNGEAL AIRWAY WITH DRAIN/SUCTION CHANNEL, MODELS KLT...
K033189 · CAE
King Systems Corp.
Anesthesiology · 216d
Cleared May 04, 2004
BZ-576 NON-INVASIVE AUTOMATIC BLOOD PRESSURE MONITOR
K033216 · DXN
The Buzz Group, LLC
Cardiovascular · 214d
Cleared May 04, 2004
INTERLAB ACID HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM
K040146 · GKA
Interlab S.R.L.
Hematology · 103d
Cleared May 04, 2004
SECTRA IDS5 RADIOLOGY WORKSTATION
K040376 · LLZ
Sectra-Imtec AB
Radiology · 77d
Cleared May 04, 2004
HEARTSTART MRX, MODEL M3535A
K040404 · MKJ
Philips Medical Systems, Inc.
Cardiovascular · 77d
Cleared May 04, 2004
ARTOSCAN C
K040877 · LNH
Esaote, S.P.A.
Radiology · 29d
Cleared May 03, 2004
ACON OPI ONE STEP OPIATE TEST STRIP AND ACON OPI ONE STEP OPIATE TEST DEVICE
K040274 · DJG
ACON Laboratories, Inc.
Toxicology · 88d
Cleared May 03, 2004
TAMPAX PEARL SCENTED TAMPONS-JUNIOR, REGULAR, SUPER & SUPER PLUS
K040312 · HIL
Procter & Gamble Co.
Obstetrics & Gynecology · 84d
Cleared May 03, 2004
FIBREX CATHETER PATENCY DEVICE
K040427 · FOZ
Medical Device Technologies, Inc.
General Hospital · 74d
Cleared May 03, 2004
EOVIA CALCIUM PHOSPHATE CERAMIC
K040514 · MQV
Ortho Tec, LLC
Orthopedic · 66d