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
159097–159120 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 15, 1982
POSITIVE I.D. SYSTEM
K823266 · JJQ
Abbott Laboratories
Microbiology · 43d
Cleared Dec 15, 1982
MODEL 402P SEQUENCER FOR EMPI TEMS DEV
K823299 · GZJ
Epmi, Inc.
Neurology · 40d
Cleared Dec 15, 1982
HEMOPHILUS QUAD 10 PLATE
K823306 · JSI
Troy Biologicals, Inc.
Hematology · 40d
Cleared Dec 15, 1982
CAMPYLOBACTER SELECTIVE AGAR
K823307 · JSI
Troy Biologicals, Inc.
Microbiology · 40d
Cleared Dec 15, 1982
STREPTOCOCCUS SELECTIVE AGAR
K823310 · JSI
Troy Biologicals, Inc.
Microbiology · 40d
Cleared Dec 15, 1982
COLUMBIA V AGAR W/5% HUMAN BLOOD
K823311 · JSH
Troy Biologicals, Inc.
Microbiology · 40d
Cleared Dec 15, 1982
OXYGENATOR 10
K823343 · DTZ
Gambro, Inc.
Cardiovascular · 37d
Cleared Dec 15, 1982
COUNT-10 STAIN
K823363 · LEE
V-Tech, Inc.
Chemistry · 36d
Cleared Dec 15, 1982
COUNT-10 SYSTEM FOR STAND. URINALYSIS
K823364 · JQW
V-Tech, Inc.
Chemistry · 36d
Cleared Dec 15, 1982
ADVANCE EMIT(R) & TM AMIKACIN CONTROL
K823369 · LAS
Syva Co.
Toxicology · 35d
Cleared Dec 15, 1982
ALLERCOAT POSITIVE CONTROL SERUM
K823403 · DGC
Kallestad Laboratories, Inc.
Immunology · 30d
Cleared Dec 15, 1982
ARM BOARD W/I.V COVERING
K823412 · BTX
Sage Products, Inc.
General & Plastic Surgery · 30d
Cleared Dec 15, 1982
NEBULIZER CHRONOLOG & INTERPRETER
K823423 · CCQ
Advanced Technology Products, Inc.
Anesthesiology · 29d
Cleared Dec 15, 1982
ALLERCOAT ALLERGEN DISCS
K823470 · DHB
Kallestad Laboratories, Inc.
Immunology · 23d
Cleared Dec 15, 1982
MODUFLEX NEONATAL VENTILATOR SET
K823479 · BZO
Bd Becton Dickinson Vacutainer...
Anesthesiology · 22d
Cleared Dec 15, 1982
ENDODONTIC BROACH-BARBED BROACH
K823489 · EKW
Union Broach, Div. Moyco Industries,...
Dental · 22d
Cleared Dec 15, 1982
FULL-DISCLOSURE AMBULATORY ECG SYSTEM
K823529 · DPS
Clinical Data, Inc.
Cardiovascular · 22d
Cleared Dec 15, 1982
STIMUCORD EXTERNAL NEURAL STIM. 911A
K823530 · GZB
Cordis Corp.
Neurology · 16d
Cleared Dec 15, 1982
BEHIND-THE-EAR HEARING AID #8003
K823531 · ESD
Danavox, Inc.
Ear, Nose, Throat · 16d
Cleared Dec 15, 1982
STEREOMED CAMERA
K823534 · FTT
Diseases of the Skin Clinic, P.A.
General & Plastic Surgery · 25d
Cleared Dec 14, 1982
CARCINO-CEK
K823353 · JJX
Biologics Intl., Inc.
Immunology · 35d
Cleared Dec 14, 1982
MODEL 640 LINEAR SCANNER
K827176
Ge Medical Systems Information...
Radiology · 42d
Cleared Dec 14, 1982
ENTREKIN MODEL DX-300 CONTINUOUS WAVE ULTRASONIC DOPPLER TRANSDUCER
K828586
Cranbury Medical Labs, Inc.
Radiology · 21d
Cleared Dec 14, 1982
MAXICAMERA 300A SMALL FIELD OF VIEW IMAGING SYSTEM
K828595
General Electric Co.
Radiology · 49d