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
152137–152160 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 07, 1984
WRIGHT STAIN BUFFER
K842914 · JCC
E K Ind., Inc.
Pathology · 44d
Cleared Sep 07, 1984
SCHIFF REAGENT, PAS STAIN
K842917 · HZT
E K Ind., Inc.
Pathology · 44d
Cleared Sep 07, 1984
REES & ECKER DILUTION FLUID
K842921 · GLG
E K Ind., Inc.
Hematology · 44d
Cleared Sep 07, 1984
PICRIC ACID SATURATED SOLUTION
K842922 · LDW
E K Ind., Inc.
Pathology · 44d
Cleared Sep 07, 1984
ORANGE G, 1%
K842924 · HZH
E K Ind., Inc.
Pathology · 44d
Cleared Sep 07, 1984
HAYEM DILUTING FLUID
K842929 · GIF
E K Ind., Inc.
Hematology · 44d
Cleared Sep 07, 1984
CARDI-CK EIA TEST KIT CK-MB ISOENZYME
K843007 · JHS
Intl. Immunoassay Laboratories, Inc.
Chemistry · 38d
Cleared Sep 07, 1984
EVER-BOND V GLASS LONOMER RESTORATIVE
K843072 · EBF
Kerr Corporation (Danbury)
Dental · 32d
Cleared Sep 07, 1984
APCO FISSURE SEALER & BONDING AGENT
K843098 · EBC
Scientific Pharmaceuticals, Inc.
Dental · 31d
Cleared Sep 07, 1984
ALBUMIN ASSAY KIT
K843104 · CIX
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 31d
Cleared Sep 07, 1984
STERILE SOLUTION BOWL
K843115 · KDD
E.M. Adams
Neurology · 30d
Cleared Sep 07, 1984
GUIDE TO THE KNEE
K843121 · BWN
Dyonics, Inc.
General & Plastic Surgery · 30d
Cleared Sep 07, 1984
MOBILE OPERATING TABLE HEIDELBERGS 1130
K843134 · GDC
Stierlen-Maquet AG
General & Plastic Surgery · 29d
Cleared Sep 07, 1984
K-BASS LO FREQUENCY HEARING AID
K843144 · ESD
Etymotic Research
Ear, Nose, Throat · 28d
Cleared Sep 07, 1984
AUGMENTIN 30 MCG SENSITIVITY DISKS
K843172 · JTN
Difco Laboratories, Inc.
Microbiology · 25d
Cleared Sep 07, 1984
TOTAL BILIRUBIN TEST
K843178 · CIG
Sclavo, Inc.
Chemistry · 25d
Cleared Sep 07, 1984
CREATININE TEST
K843179 · CGX
Sclavo, Inc.
Chemistry · 25d
Cleared Sep 07, 1984
SALICYLATE TEST
K843180 · DKJ
Sclavo, Inc.
Toxicology · 25d
Cleared Sep 07, 1984
T-TYPE IV EXTENSION SET
K843249 · FPA
Strato Medical Corp.
General Hospital · 18d
Cleared Sep 07, 1984
SYSTEMATE CK-TOTAL - 67206
K843271 · CGS
Em Diagnostic Systems, Inc.
Chemistry · 18d
Cleared Sep 07, 1984
DIFFERENTIATION DISKS BILE ESCULIN
K843364 · JSF
Difco Laboratories, Inc.
Microbiology · 10d
Cleared Sep 07, 1984
MOLINEA UNDERPADS
K843402 · KME
Paul Hartmann Corp.
General Hospital · 8d
Cleared Sep 07, 1984
TOP HYPODERMIC SYRINGE PISTON
K843414 · FMF
Top Surgical Manufacturers Co.
General Hospital · 7d
Cleared Sep 06, 1984
MONITORING KIT
K833171 · DRS
Transamerica Delaval, Inc.
Cardiovascular · 356d