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
137425–137448 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 29, 1988
PTI HEART-CHILL(TM) CARDIAC INSULATING JACKET
K874927 · DWC
Pioneering Technologies, Inc.
Cardiovascular · 58d
Cleared Jan 29, 1988
ADDITIONAL ALLERGENS FOR ALLERG*ENS EIA KIT
K875066 · DHB
Dexall Biomedical Labs, Inc.
Immunology · 51d
Cleared Jan 29, 1988
UNICATH LAB
K875184 · IZI
Xre Corp.
Radiology · 38d
Cleared Jan 29, 1988
MICRODISCECTOMY CURETTE SET
K875292 · FZS
T. Korossurgical Instruments Corp.
General & Plastic Surgery · 30d
Cleared Jan 29, 1988
EDEC 90C
K875342 · IZO
Electromed Intl., Ltd.
Radiology · 30d
Cleared Jan 29, 1988
OMED DISPOSABLE SCALPEL
K880028 · GDX
Oxboro Medical Intl., Inc.
General & Plastic Surgery · 24d
Cleared Jan 29, 1988
CARETEX SKID RESISTANT SHOE COVERS
K880093 · FXP
James River Corp.
General Hospital · 17d
Cleared Jan 28, 1988
ADVANCED HAND HELD CO2 LASER/HH-550 FOR DOED USE
K864946 · HHR
Bio Quantum Technologies, Inc.
Obstetrics & Gynecology · 407d
Cleared Jan 28, 1988
STAND. CLEAR VINYL DISPOSABLE ECG ELECT.(594 ADHE)
K872866 · DRX
Labeltape Meditect, Inc.
Cardiovascular · 191d
Cleared Jan 28, 1988
CABOT FIBER LASER PROBE
K873115 · HET
Cabot Medical Corp.
Obstetrics & Gynecology · 171d
Cleared Jan 28, 1988
BIOTIS (TM) SABHI (DOUBLE POUR)
K874179 · KZI
Otisville Biopharm, Inc.
Microbiology · 107d
Cleared Jan 28, 1988
450SLL DEFIBRILLATOR
K874204 · LDD
Medical Research Laboratories, Inc.
Cardiovascular · 105d
Cleared Jan 28, 1988
PRE-GELLED DISPOSABLE ECG ELECTRODE - HP13941A
K874421 · DRX
Hewlett-Packard Co.
Cardiovascular · 92d
Cleared Jan 28, 1988
PRE-GELLED DISPOSABLE CLEAR TAPE ECG ELEC.HP13942D
K874422 · DRX
Hewlett-Packard Co.
Cardiovascular · 92d
Cleared Jan 28, 1988
PRE-GELLED DISPOSABLE ECG ELECTRODE - HP40493E
K874423 · DRX
Hewlett-Packard Co.
Cardiovascular · 92d
Cleared Jan 28, 1988
PRE-GELLED DISPOSABLE ECG TAPE ELECTRODE HP40489E
K874424 · DRX
Hewlett-Packard Co.
Cardiovascular · 92d
Cleared Jan 28, 1988
TRANSCUTANEOUS ELECTRIC NERVE STIMULATION (TENS)
K874469 · GXY
Axelgaard Mfg. Co., Ltd.
Neurology · 87d
Cleared Jan 28, 1988
SUPER FLOSSER
K874471 · JES
U.S. Pacific Corp.
Dental · 87d
Cleared Jan 28, 1988
BISCO PIT AND FISSURE SEALANT
K874556 · EBC
Bisco, Inc.
Dental · 85d
Cleared Jan 28, 1988
BISCO PORCELAIN REPAIR KIT
K874557 · EBC
Bisco, Inc.
Dental · 85d
Cleared Jan 28, 1988
SECURATRODE
K874562 · DRX
Meddev International Corp.
Cardiovascular · 85d
Cleared Jan 28, 1988
MEDTRONIC(R) ORTHOFLEX(TM)
K874884 · BXB
Metronic, Inc.
Physical Medicine · 58d
Cleared Jan 28, 1988
SELF-RETAINING RETRACTOR FOR NEUROSURGERY
K874956 · GZT
Solway, Inc.
Neurology · 57d
Cleared Jan 28, 1988
TRACETS 3000
K875015 · DRX
Lectec Corp.
Cardiovascular · 55d