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
80449–80472 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 19, 2001
C1-INHIBITOR MICROTITER ASSAY DEVICE
K003747 · DBA
Baxter Healthcare Corp
Immunology · 105d
Cleared Mar 19, 2001
ACCU-CHEK INFORM METER
K003846 · LFR
Roche Diagnostics Corp.
Chemistry · 97d
Cleared Mar 19, 2001
NEXGEN COMPLETE KNEE SOLUTION CROSS-LINKED POLYETHYLENE CRUCIATE RETAINING...
K003910 · JWH
Zimmer, Inc.
Orthopedic · 90d
Cleared Mar 19, 2001
BAUMER CEMENTED HIP PROSTHESIS
K003975 · JDI
Baumer, S.A
Orthopedic · 87d
Cleared Mar 19, 2001
BAUMER MULLER HIP PROSTHESIS
K003976 · JDI
Baumer, S.A
Orthopedic · 87d
Cleared Mar 19, 2001
MEDTRADE PRODUCTS SILICON SCAR MANAGEMENT PAD
K003979 · MDA
Medtrade Products , Ltd.
General & Plastic Surgery · 87d
Cleared Mar 19, 2001
SUPER REVO SUTURE ANCHOR
K003984 · MAI
Linvatec Corp.
Orthopedic · 83d
Cleared Mar 19, 2001
STERILE SUBDERMAL NEEDLE ELECTRODES
K010019 · GXZ
Nicolet Biomedical, Inc.
Neurology · 76d
Cleared Mar 19, 2001
RESPIRONICS BILICHEK NON-INVASIVE-100-0800-20
K010052 · MQM
Respironics, Inc.
Chemistry · 70d
Cleared Mar 19, 2001
XLTEK REAL PATIENT EVOKED POTENTIAL HEADBOX, MODEL EP-16-RP
K010087 · GWF
Excel Tech. , Ltd.
Neurology · 67d
Cleared Mar 19, 2001
TRIFIX SPINAL FIXATION SYSTEM
K010535 · MNH
Endius, Inc.
Orthopedic · 24d
Cleared Mar 19, 2001
MICROWAVAE DELIVERY SYSTEM #MW2000
K010589 · MWY
Mw Medical, Inc.
General & Plastic Surgery · 20d
Cleared Mar 18, 2001
4 PORT, 4 WAY STOPCOCK
K010217 · FMG
George Loo, MD
General Hospital · 53d
Cleared Mar 18, 2001
NPAC MULTI-USE THERMOMETER, MODEL TD400
K010224 · FLL
Norm Pacific Automation Corp.
General Hospital · 53d
Cleared Mar 16, 2001
COOK PRESSURE MONITORING CATHETER
K002254 · DQO
Cook, Inc.
Cardiovascular · 234d
Cleared Mar 16, 2001
ROCHE DIAGNOSTICS TINA-QUANT D-DIMER ON COBAS INTEGRA
K002706 · DAP
Roche Diagnostics Corp.
Hematology · 198d
Cleared Mar 16, 2001
E MOTION WHEELCHAIR DRIVE SYSTEM (POWER-ASSIST FOR MANUAL WHEELCHAIRS)
K003449 · ITI
Ulrich Alber GmbH & Co.
Physical Medicine · 129d
Cleared Mar 16, 2001
HINT AUDIOMETER, OR HINT
K003913 · EWO
Maico-Diagnostics
Ear, Nose, Throat · 87d
Cleared Mar 16, 2001
INDIGO LASEROPTIC TREATMENT SYSTEM
K003952 · GEX
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 85d
Cleared Mar 16, 2001
INDIGO DIFFUSER-TIP FIBEROPTIC WITH TEMPERATURE SENSING OPTION, MODEL LF001
K003953 · GEX
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 85d
Cleared Mar 16, 2001
MRI SAFE INSTRUMENTS
K003965 · GEA
Aesculap, Inc.
General & Plastic Surgery · 84d
Cleared Mar 16, 2001
SPECULITE/ORALLITE
K003995 · EAZ
Trylon Corp.
Dental · 80d
Cleared Mar 16, 2001
MD 30 COMPACT
K004014 · GEX
General Project
General & Plastic Surgery · 84d
Cleared Mar 16, 2001
REAL PATIENT REAL PATIENT 128 CHANNEL EEG HEADBOX, MODEL EX-NW-128-RP
K010084 · GWQ
Excel Tech. , Ltd.
Neurology · 64d