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
73657–73680 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 31, 2003
RTDOSEPLAN
K022961 · MUJ
Math Resolutions, LLC
Radiology · 147d
Cleared Jan 31, 2003
ITC HGB PRO PROFESSIONAL HEMOGLOBIN TESTING SYSTEM
K023561 · GKR
International Technidyne Corp.
Hematology · 100d
Cleared Jan 31, 2003
ADVANTAGE MULTIPLE DRUGS OF ABUSE TEST
K023712 · DKZ
Advantage Diagnostics Corp.
Toxicology · 88d
Cleared Jan 31, 2003
CALIBRATION PACK, MODELS A9100-101S AND A9100-103S
K023792 · JIX
Thermo Orion
Chemistry · 79d
Cleared Jan 31, 2003
AHL GENERIC GLASS IONOMER LUTING CEMENT
K023981 · EMA
Advanced Healthcare , Ltd.
Dental · 60d
Cleared Jan 31, 2003
MODIFICATION TO OLYMPUS BRONCHOSCOPES BF-40 SERIES, BF-240 SERIES, AND BF-160...
K023984 · EOQ
The Olympus Optical Co.
Ear, Nose, Throat · 60d
Cleared Jan 31, 2003
PERMANENT PACING LEADS, MODELS PHYSIQUE PB AND PJB
K024053 · DTB
Oscor, Inc.
Cardiovascular · 53d
Cleared Jan 31, 2003
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - RIFAMPIN 0.25-32 UG/ML
K024152 · LON
Becton, Dickinson & CO
Microbiology · 45d
Cleared Jan 31, 2003
MODIFICATION TO PENTRA 60 AND PENTRA 60C+
K030144 · GKZ
Abx Diagnostics
Hematology · 16d
Cleared Jan 31, 2003
SETPOINT CHEMISTRY CALIBRATOR
K030169 · JIX
Bayer Healthcare, LLC
Chemistry · 14d
Cleared Jan 30, 2003
AECP-A, AUTOMATIC EXTERNAL COUNTERPULSATION DEVICE
K021340 · DRN
External Counterpulsation Lab
Cardiovascular · 279d
Cleared Jan 30, 2003
TRUFLOW LONG-TERM AND SHORT-TERM DUAL-LUMEN DIALYSIS CATHETERS
K022221 · MPB
Deltec, Inc.
Gastroenterology & Urology · 205d
Cleared Jan 30, 2003
LEMAITRE VASCULAR DISPOSABLE VEIN STRIPPER
K023688 · GAF
LeMaitre Vascular, Inc.
General & Plastic Surgery · 90d
Cleared Jan 30, 2003
ANGIONEW-IV
K023701 · DRN
Living Data Technologies Corporation
Cardiovascular · 87d
Cleared Jan 30, 2003
BI-OSTETIC
K023703 · MQV
Berkeley Advanced Biomaterials, Inc.
Orthopedic · 87d
Cleared Jan 30, 2003
KSEA SCB ACC CONTROL
K023704 · FTA
KARL STORZ Endoscopy-America, Inc.
General & Plastic Surgery · 87d
Cleared Jan 30, 2003
GRADIA DIRECT
K023814 · EBF
GC America, Inc.
Dental · 76d
Cleared Jan 30, 2003
ACROSEAL ROOT CANAL OR APICAL SEALER
K023976 · KIF
Septodont S.A.S.
Dental · 64d
Cleared Jan 30, 2003
BAYER ADVIA CENTAUR HER-2/NEU ASSAY
K024017 · NCW
Bayer Corp.
Immunology · 57d
Cleared Jan 29, 2003
CARDIMA ABLATION SYSTEM
K022008 · OCL
Cardima, Inc.
Cardiovascular · 224d
Cleared Jan 29, 2003
MELADINE NATURAL MELANIN ENHANCER, PRODUCT NUMBER CT81602AA
K022807 · GEX
Creative Technologies, Inc.
General & Plastic Surgery · 159d
Cleared Jan 29, 2003
SAS RSV TEST
K022845 · GQG
Sa Scientific, Inc.
Microbiology · 155d
Cleared Jan 29, 2003
1-CCD ENDOCAM 5520 SYSTEM
K023659 · FET
Richard Wolf Medical Instruments Corp.
Gastroenterology & Urology · 90d
Cleared Jan 29, 2003
OSMETECH MICROBIAL ANALYSER-BACTERIAL VAGINOSIS (OMA-BV)
K023677 · LIB
Osmetech
Microbiology · 89d