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
167689–167712 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 16, 1980
SMAC REPLACEMENT REAGENTS-WASH SOLUTIONS
K800671
Diagnostic Solutions, Inc.
Chemistry · 21d
Cleared Apr 16, 1980
STANBIO PROSTATIC ACID PHOSPHATASE TEST
K800693 · CKE
Stanbio Laboratory
Chemistry · 20d
Cleared Apr 16, 1980
AMERLEX CORTISOL RIA KIT
K800700 · CGR
Amersham Corp.
Chemistry · 19d
Cleared Apr 16, 1980
MEDI-TRACE TRANSDUCERS/PHYSIOLOG. MONITO
K800705 · DRS
Graphic Controls Corp.
Cardiovascular · 16d
Cleared Apr 16, 1980
MEDI-TRACE DISPOSABLE DOMES/MONITORING
K800706 · DRS
Graphic Controls Corp.
Cardiovascular · 16d
Cleared Apr 16, 1980
CODE QAS.105 PROLACTIN CONTROL SERA
K800708 · JJX
Amersham Corp.
Chemistry · 16d
Cleared Apr 16, 1980
TOPICAL COOLING DEV. TCD. #27-999
K800717 · DTR
Cobe Laboratories, Inc.
Cardiovascular · 16d
Cleared Apr 16, 1980
AMES LAB MANAGEMENT SYSTEM
K800724 · JQP
Miles Laboratories, Inc.
Microbiology · 15d
Cleared Apr 16, 1980
GOODE T-TUBE, BIOLITE COATED SILICONE/TU
K800727 · ETD
Xomed, Inc.
Ear, Nose, Throat · 15d
Cleared Apr 16, 1980
PAPARELL TYPE 2, BIOLITE COATED SILI-
K800728 · ETD
Xomed, Inc.
Ear, Nose, Throat · 15d
Cleared Apr 16, 1980
PROLACTIN RIA KIT
K800740 · CFT
Amersham Corp.
Chemistry · 13d
Cleared Apr 16, 1980
CENTRAL VEIN CATHETERIZATION KIT
K800741 · DQO
Medical Components, Inc.
Cardiovascular · 13d
Cleared Apr 16, 1980
TOBRAMYCIN RIA KIT
K800743 · KLB
Antibodies, Inc.
Toxicology · 13d
Cleared Apr 16, 1980
DUNRICH TABLES
K800756 · ETF
Dunrich, Inc.
Ear, Nose, Throat · 12d
Cleared Apr 10, 1980
413A NEONATAL MONITOR
K800164 · FLS
Xerox Corp.
Anesthesiology · 76d
Cleared Apr 10, 1980
D668 & D664 CENTRAL MONITORING SYSTEMS
K800243 · DRT
Medtel Pty. , Ltd.
Cardiovascular · 65d
Cleared Apr 10, 1980
ANTERIOR & POST. RESTORATIVE PASTE SYS.
K800389 · KLE
American Dental Research
Dental · 50d
Cleared Apr 10, 1980
ANT. & POST. RESTORATIVE POWDER LIQ.
K800390 · KLE
American Dental Research
Dental · 50d
Cleared Apr 10, 1980
PAINT-ON-RESTORATIVE W/FISSURE SEALER
K800391 · EBC
American Dental Research
Dental · 50d
Cleared Apr 10, 1980
BRACKET BONDING SYSTEM METAL & PLASTIC
K800392 · DYH
American Dental Research
Dental · 50d
Cleared Apr 10, 1980
POLY SULFIDE IMPRESSION PASTE W/CATALYST
K800393 · ELW
American Dental Research
Dental · 50d
Cleared Apr 10, 1980
LUNDIA PLATE DISP.
K800424 · FJG
Gambro, Inc.
Gastroenterology & Urology · 44d
Cleared Apr 10, 1980
PORTABLE MEDICAL ULTRASOUND SCANNER
K800434 · IYO
Bion Ent., Ltd.
Radiology · 43d
Cleared Apr 10, 1980
PFIZER/AS&E 0450 LOCALIZER
K800501 · JDX
Pfizer Medical Systems, Inc.
Radiology · 37d