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
142321–142344 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 13, 1986
MODEL AQ8181 CUSTOM-CANAL-IN-THE EAR HEARING AID
K864028 · ESD
Int'L Hearing Aids, Inc.
Ear, Nose, Throat · 29d
Cleared Nov 13, 1986
AY8182 CUSTOM-SEMI CANAL-IN-THE-EAR HEARING AID
K864029 · ESD
Int'L Hearing Aids, Inc.
Ear, Nose, Throat · 29d
Cleared Nov 13, 1986
MODEL AJ8183 CUSTOM-IN-THE-EAR HEARING AID
K864030 · ESD
Int'L Hearing Aids, Inc.
Ear, Nose, Throat · 29d
Cleared Nov 13, 1986
MODEL AK 8184 CUSTOM-LOW-PROFILE HEARING AID
K864031 · ESD
Int'L Hearing Aids, Inc.
Ear, Nose, Throat · 29d
Cleared Nov 13, 1986
RAPID ACID FAST STAIN
K864033 · KJY
Sigma Diagnostics, Inc.
Pathology · 29d
Cleared Nov 13, 1986
KERASCAN MODEL 2000 KERATOGRAPHIC AUTO ANALYZER
K864037 · HJB
Kera Corp.
Ophthalmic · 28d
Cleared Nov 13, 1986
ORION 3001, LASER PHOTOCOAGULATOR
K864063 · HQF
G. Rodenstock Instrumente GmbH
Ophthalmic · 24d
Cleared Nov 13, 1986
PRECEPT (TM) TICARCILLIN/CLAVULANIC ACID
K864069 · JWY
Austin Biological Laboratories
Microbiology · 24d
Cleared Nov 13, 1986
FAULKNER FORCEPS
K864071 · HNR
Staar Surgical Co.
Ophthalmic · 24d
Cleared Nov 13, 1986
UBI MAGIWEL(TM) FSH QUANTITATIVE
K864080 · CGJ
United Biotech, Inc.
Chemistry · 24d
Cleared Nov 13, 1986
MECHANICAL OXYGEN REGULATOR
K864127 · NFB
Travomed, Inc.
Anesthesiology · 23d
Cleared Nov 13, 1986
OPTI-BRUSH
K864157 · LPN
Willmar Contact Lens Clinic
Ophthalmic · 21d
Cleared Nov 13, 1986
HILL-ROM CENTURY CC, MODELS 891 & 893 WEIGHING SYS
K864172 · FNL
Hill-Rom, Inc.
General Hospital · 20d
Cleared Nov 13, 1986
HILL-ROM CENTURY CC MODELS 892 &894 (RADIOLUCENT)
K864186 · FNL
Hill-Rom, Inc.
General Hospital · 17d
Cleared Nov 13, 1986
MODEL 35-B ALL LEVEL COT
K864269 · FPO
Ferno-Washington, Inc.
General Hospital · 15d
Cleared Nov 13, 1986
THROMBOPLASTIN.FS
K864272 · GJS
American Dade
Hematology · 15d
Cleared Nov 13, 1986
THROMBOPLASTIN.C
K864273 · GJS
American Dade
Hematology · 15d
Cleared Nov 13, 1986
THROMBOPLASTIN.R
K864274 · GJS
American Dade
Hematology · 15d
Cleared Nov 12, 1986
PRISTINE/BLOOMING/PRISTINE BLOOMING CULTURE CATH
K862098 · KOD
Hall/Mccollum Laboratories, Inc.
Gastroenterology & Urology · 163d
Cleared Nov 12, 1986
SIGMA II - DUAL PLACE HYPERBARIC CHAMBER
K862198 · CBF
Perry Baromedical Services
Anesthesiology · 156d
Cleared Nov 12, 1986
PC-DISPLAY
K862309 · LLZ
Hi-Tech Medical Systems, Inc.
Radiology · 148d
Cleared Nov 12, 1986
BIOSOICS SPHINCTER TRAINING SYSTEM
K862683 · KPN
Biosonics, Inc.
Gastroenterology & Urology · 120d
Cleared Nov 12, 1986
K-STIK DEFIBRILLATION PADS
K863899 · LDD
Katecho, Inc.
Cardiovascular · 36d
Cleared Nov 12, 1986
ABBOTT B2-MICROGLOBULIN RIA
K864130 · JZG
Abbott Laboratories
Immunology · 22d