FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
79849–79872 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Mar 16, 2001
DIMENSION ENZYMATIC CARBONATE (ECO2) FLEX METHOD, CATALOG DF137
K010206 · KHS
Dade Behring, Inc.
Chemistry · 52d
Cleared Mar 16, 2001
VISTAKON (HEFILCON C) CONTACT LENSES
K010218 · LPL
Vistakon
Ophthalmic · 51d
Cleared Mar 16, 2001
BIOCURVE SOFT (METHAFILCON A) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY...
K010223 · LPL
American Contact Lens, Inc.
Ophthalmic · 51d
Cleared Mar 16, 2001
TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST, CATALOG #98000
K010266 · NBC
Biosite Incorporated
Chemistry · 46d
Cleared Mar 16, 2001
SCIMEDX PHASE II PR3 IGG ANTIBODY EIA
K010287 · MOB
Scimedx Corp.
Immunology · 44d
Cleared Mar 16, 2001
MN-4 COARSE MANIPULATOR
K010298 · MQJ
Narishige Co., Ltd.
Obstetrics & Gynecology · 44d
Cleared Mar 16, 2001
CBC-SF
K010409 · JPK
R&D Systems, Inc.
Hematology · 32d
Cleared Mar 16, 2001
PRECISE NITINOL STENT TRANSHEPATIC BILLARY SYSTEM
K010445 · FGE
Cordis Corp.
Gastroenterology & Urology · 30d