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

Filters: Cleared only ×
176,076 results
82249–82272 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 23, 2000
3M COMPLY 1249 LIQUID PERACETIC ACID CHEMICAL INDICATOR
K000355 · JOJ
Minnesota Mining and Mfg. Co.
General Hospital · 201d
Cleared Aug 23, 2000
OFFICE BASED ANESTHESIA MACHINE, MODEL OBA-1
K000859 · BSZ
Charles A. Smith
Anesthesiology · 159d
Cleared Aug 23, 2000
DATEX-OHMEDA COMPACT AIRWAY MODULE M-CAIOVX AND M-COVX (VERSION 01) AND...
K001814 · CCK
Datex-Ohmeda
Anesthesiology · 69d
Cleared Aug 23, 2000
CHRONALCO I.D.CDT (CARBOHYDRATE DEFICIENT TRANSFERRIN) ASSAY
K001943 · NAO
Sangui Biotech, Inc.
Chemistry · 58d
Cleared Aug 23, 2000
RENDER-PLAN 3-D 4.00 & PRECISE-PLAN 1.0
K002240 · MUJ
Precision Therapy Intl., Inc.
Radiology · 30d
Cleared Aug 23, 2000
PALM PUMP
K002434 · MEA
Sorenson Medical, Inc.
General Hospital · 14d
Cleared Aug 23, 2000
CECILIA PENGUIN MULTI-USE THERMOMETER, MODEL HP-ETO9999
K993950 · FLL
Nien Made Electrnics Corp.
General Hospital · 275d
Cleared Aug 22, 2000
BRACHYSEED
K000475 · KXK
Draximage, Inc.
Radiology · 189d
Cleared Aug 22, 2000
MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IR1DA1
K000969 · FLL
Microlife Corp.
General Hospital · 148d
Cleared Aug 22, 2000
BIOBAR, IMPLANTABLE BIODEGRADABLE COLLAGEN MEMBRANE FOR GUIDED BONE REGENERATION
K001598 · LYC
Col-Bar , Ltd.
Dental · 90d
Cleared Aug 22, 2000
KSEA MONOPOLAR VAPORIZATION ELECTRODES
K001740 · HIH
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 75d
Cleared Aug 22, 2000
IMPROVED ENLIGHT LV
K001881 · DYH
Sybron Dental Specialties, Inc.
Dental · 62d
Cleared Aug 22, 2000
ACCESS TESTOSTERONE REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY ANALYZER,...
K001935 · CDZ
Beckman Coulter, Inc.
Chemistry · 57d
Cleared Aug 22, 2000
PATIENT LATEX POLYMER COATED POWDER-FREE GLOVES, CONTAINS 50 MICROGRAM OR...
K002065 · LYY
Comfort Rubber Gloves Industries Sdn....
General Hospital · 46d
Cleared Aug 22, 2000
ELECSYS HCG TEST SYSTEM
K002148 · DHA
Roche Diagnostics Corp.
Chemistry · 36d
Cleared Aug 22, 2000
DOCUMENT ASSAYED CHEMISTRY CONTROL, LEVELS 1, 2 AND3
K002174 · JJY
Casco-Nerl Diagnostics Corporation...
Chemistry · 34d
Cleared Aug 22, 2000
EPIC SPO2 FINGER SENSOR, MODEL E412-20
K002223 · DQA
Epic Medical Equipment Services, Inc.
Anesthesiology · 29d
Cleared Aug 22, 2000
CAPIOX SX HARDSHELL RESERVOIR WITH X-COATING
K002238 · DTN
Terumo Cardiovascular Systems Corp.
Cardiovascular · 29d
Cleared Aug 22, 2000
VINYL EXAMINATION GLOVE, POWDER-FREE, YELLOW
K002340 · LYZ
Glormed Intl., Inc.
General Hospital · 21d
Cleared Aug 21, 2000
GLYCOSAL HBA1C TEST
K001392 · LCP
Provalis Diagnostics , Ltd.
Hematology · 110d
Cleared Aug 21, 2000
WHOLE PTH (1-84) SPECIFIC IMMUNORADIOMETRIC IRMA DIAGNOSTIC ASSAY KIT, MODEL...
K001411 · CEW
Scantibodies Laboratory, Inc.
Chemistry · 109d
Cleared Aug 21, 2000
CARESIDE HEMOGLOBIN
K001462 · KHG
Careside, Inc.
Hematology · 103d
Cleared Aug 21, 2000
HEP-2 ANA TEST SYSTEM WITH IF-AIM TECHNOLOGY
K001556 · DHN
The Binding Site, Ltd.
Immunology · 95d
Cleared Aug 21, 2000
SYSMEX R-500
K001683 · GKL
Sysmex Corporation of America
Hematology · 81d