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
81649–81672 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Aug 21, 2000
DIAMEDIX IS-RUBELLA IGM CAPTURE TEST SYSTEM
K001875 · LFX
Diamedix Corp.
Microbiology · 62d
Cleared Aug 21, 2000
DIASTAT ANTI-CARDIOLIPIN IGA, MODEL FCAR 500
K001981 · MID
Axis-Shield , Ltd.
Immunology · 53d
Cleared Aug 21, 2000
LIQUICHEK BLOOD GAS CONTROL, MODEL 571, 572, 573
K002120 · JJS
Bio-Rad
Chemistry · 39d
Cleared Aug 18, 2000
DOSE 1
K000209 · IYE
Scanditronix Wellhofer North America
Radiology · 207d
Cleared Aug 18, 2000
FLO ASSISTANT, MODEL 4-250-00
K001325 · LJH
Northgate Technologies, Inc.
Gastroenterology & Urology · 114d
Cleared Aug 18, 2000
CANDELA DYNAMIC COOLING DEVICE
K001589 · GEX
Candela Corp.
General & Plastic Surgery · 87d
Cleared Aug 18, 2000
HUNTER SCIENTIFIC INJECTION PIPETTES
K001615 · MQH
Hunter Scientific Limited
Obstetrics & Gynecology · 85d
Cleared Aug 18, 2000
XIA SPINE SYSTEM SACRAL BLOCK ASSEMBLY
K001653 · KWP
Howmedica Osteonics Corp.
Orthopedic · 80d