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
167929–167952 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 12, 1980
AMERLEX T-3 RIA KIT
K800374 · CDP
Amersham Corp.
Chemistry · 20d
Cleared Mar 12, 1980
NML 5000 AUTO. GAMMA SCINT. COUNTER
K800388 · JJJ
Nuclear Medical Laboratories, Inc.
Toxicology · 16d
Cleared Mar 12, 1980
PARACONTROL ABNORMAL IMMUNOGLOBULIN CONT
K800398 · DEW
Diagnostica, Inc.
Immunology · 15d
Cleared Mar 12, 1980
MAXUM DENTURE RESIN
K800400 · EBI
Dentsply Intl.
Dental · 15d
Cleared Mar 12, 1980
INFRASONDE D4000 ELECTRONIC B-P MONITOR
K800401 · DXN
Sphygmetrics, Inc.
Cardiovascular · 15d
Cleared Mar 12, 1980
FERRIS BONE MARROW BIOPSY-ASPIR. NEEDLE
K800406 · GDM
A.D.T. Lab Industries
General & Plastic Surgery · 15d
Cleared Mar 12, 1980
FERRIS BONE MARROW -NEEDLE-(DISPOSABLE)
K800407 · GAA
A.D.T. Lab Industries
General & Plastic Surgery · 15d
Cleared Mar 12, 1980
ADT MINI PERITONEAL LAVAGE KIT
K800422 · GBW
A.D.T. Lab Industries
General & Plastic Surgery · 15d
Cleared Mar 12, 1980
HEMOSTATIC/TUBE OCCLUDING FORCEPS
K800435 · GEN
Dravon Medical, Inc.
General & Plastic Surgery · 14d
Cleared Mar 12, 1980
SYRINGE TIP CONNECTOR
K800437 · KYX
Burron Medical Products, Inc.
General Hospital · 14d
Cleared Mar 12, 1980
DENTAL CAVITY VARNISH, CONCENTRATED
K800438 · LBH
Scientific Pharmaceuticals, Inc.
Dental · 13d
Cleared Mar 12, 1980
ADR COMPOSITE RESTORATIVE
K800439 · EBF
Scientific Pharmaceuticals, Inc.
Dental · 13d
Cleared Mar 12, 1980
EDINBURGH MASKER
K800445 · KTH
Foundation For Fluency, Inc.
Ear, Nose, Throat · 13d
Cleared Mar 12, 1980
GEMENI IGA ASSAY
K800449 · CZP
Electro-Nucleonics Laboratories, Inc.
Immunology · 12d
Cleared Mar 12, 1980
CENTRAL VENOUS PRESSURE CATHETER
K800461 · DQO
Medical Components, Inc.
Cardiovascular · 12d
Cleared Mar 12, 1980
STERILE DRESSING PACK
K800490 · KKX
Medi-Spec
General Hospital · 8d
Cleared Mar 12, 1980
THE LENS OR OMMI-GARD
K800521 · HQG
Gentex Corporation
Ophthalmic · 6d
Cleared Mar 10, 1980
3M SMALL VOLUME INFUSTION (SVI) SYSTEM
K792050 · FRN
3M Company
General Hospital · 150d
Cleared Mar 10, 1980
AMBLYOPIA TRAINER
K800112 · HPL
Life-Tech Instruments, Inc.
Ophthalmic · 54d
Cleared Mar 10, 1980
MICRONTA BP-1 ELECTRONIC B/P TESTER
K800225 · DXN
Tandy Corp.
Cardiovascular · 34d
Cleared Mar 10, 1980
MOIRE FRINGE VISOMETER AFTER LOTMAR
K800238 · HKL
Hagg-Streit Service, Inc.
Ophthalmic · 34d
Cleared Mar 10, 1980
0.45% SODIUM CHLORIDE SOL./RESP. THERAPY
K800294 · CAF
Abbott Laboratories
Anesthesiology · 28d
Cleared Mar 10, 1980
0.9% SODIUM CHLORIDE SOL./RESP. THERAPY
K800295 · CAF
Abbott Laboratories
Anesthesiology · 28d
Cleared Mar 10, 1980
DOUBLETIME 2-TIPPED APPLIERS FOR HEMOCLI
K800318 · HBT
Edward Weck, Inc.
General & Plastic Surgery · 27d