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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
140041–140064 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 03, 1987
MULTIPLE SPECTACLE LENS
K871961 · HQG
Korea Asahi Optical Co., Ltd.
Ophthalmic · 14d
Cleared Jun 02, 1987
INTRAUTERINE HEMOSTASIS BALLOON STENT
K863439 · KNA
Mentor Corp.
Obstetrics & Gynecology · 270d
Cleared Jun 02, 1987
ELECTROCONVULSIVE THERAPY DEVICE, MODEL MF-1000
K863815 · QGH
Elcot, Inc.
Neurology · 245d
Cleared Jun 02, 1987
POET OXIMETER
K864745 · DQE
Criticare Systems, Inc.
Cardiovascular · 179d
Cleared Jun 02, 1987
CENTRAL VEIN CATHERIZATION KIT W/WITHOUT MEDICA.
K870411 · DQY
Medical Surgical Concepts, Inc.
Cardiovascular · 119d
Cleared Jun 02, 1987
ELECTRO-NERVE STIMULATOR TENS MODEL B5/SKN
K871125 · GZJ
Biomedical Life Systems, Inc.
Neurology · 74d
Cleared Jun 02, 1987
ELECTRO-NERVE STIMULATOR TENS MODEL C & B11, B11C
K871126 · GZJ
Biomedical Life Systems, Inc.
Neurology · 74d
Cleared Jun 02, 1987
HEALTH CONCEPTS CONDUCTIVE MEMBRANE
K871292 · GXY
Health Concepts, Inc.
Neurology · 63d
Cleared Jun 02, 1987
KIT, FIRST AID, GENERAL PURPOSE, RIGID CASE
K871501 · LRR
Fraass Survival Systems, Inc.
General & Plastic Surgery · 46d
Cleared Jun 02, 1987
OMNIFIT(R) TOTAL KNEE SYSTEM (MODIFICATION)
K871769 · JWH
Osteonics Corp.
Orthopedic · 27d
Cleared Jun 02, 1987
MUCATE AGAR, SLANTS AND MUCATE BROTH
K872020 · JSH
Bd Becton Dickinson Vacutainer...
Microbiology · 7d
Cleared Jun 01, 1987
KDI QUIK TEST(TM) MARIJUANA SCREEN
K870197 · LDJ
Keystone Diagnostics, Inc.
Toxicology · 132d
Cleared Jun 01, 1987
PERCUTANEOUS SHEATH W/WO MEDI. (5,6,7,8,8.5FR)
K870413 · DRE
Medical Surgical Concepts, Inc.
Cardiovascular · 118d
Cleared Jun 01, 1987
STANBIO ALPHA-AMYLASE TEST SET, CATALOG 0180-715
K870746 · JFJ
Stanbio Laboratory
Chemistry · 96d
Cleared Jun 01, 1987
AXIAL COMPRESSION SCREW
K870786 · KTT
Straub Clinic and Hospital
Orthopedic · 95d
Cleared Jun 01, 1987
PDA699/PDA700 PROTAMINE DOSE ASSAY FOR HEP. NEUTRA
K870831 · JPA
International Technidyne Corp.
Hematology · 90d
Cleared Jun 01, 1987
ALKALINE PHOSPHATASE INDOLYL BLUE REAGENT
K870890 · CIN
Helena Laboratories
Chemistry · 88d
Cleared Jun 01, 1987
LASE SYSTEM II
K871334 · GEX
Lase, Inc.
General & Plastic Surgery · 59d
Cleared Jun 01, 1987
FETALERT ADR FETAL MONITOR
K871383 · HGM
Advanced Technology Laboratories, Inc.
Obstetrics & Gynecology · 55d
Cleared Jun 01, 1987
THEOPHYLLINE FPIA CALIBRATORS
K871394 · DLJ
Sigma Diagnostics, Inc.
Toxicology · 55d
Cleared Jun 01, 1987
STERILIZATION INDICATOR FOR FLASH STERILIZATION
K871672 · LRT
Propper Mfg. Co., Inc.
General Hospital · 34d
Cleared Jun 01, 1987
TRACHEOSTOMY & NASAL SUCTIONING KIT, 3C-TNS-1
K871692 · LRQ
Automatic Liquid Packaging, Inc.
General & Plastic Surgery · 33d
Cleared Jun 01, 1987
ULTRAFLOW
K871901 · FZH
Custom Industries, Inc.
General & Plastic Surgery · 17d
Cleared Jun 01, 1987
SURGITEK DISPOSABLE BIPOLAR CORD
K871910 · GEI
Dermacare Products, Inc.
General & Plastic Surgery · 14d