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

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176,076 results
166609–166632 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 09, 1980
CAM-10 RESPIRATORY HOSE ASSEMBLIES
K801859 · BZO
Lifecare Services, Inc.
Anesthesiology · 35d
Cleared Sep 09, 1980
PEEP FACE MASK
K801883 · BYG
Vital Signs, Inc.
Anesthesiology · 33d
Cleared Sep 09, 1980
HANCOCK * OBTURATORS
K801885 · DTI
Hancock Laboratories, Inc.
Cardiovascular · 33d
Cleared Sep 09, 1980
LIFE CERVICAL ADJUSTING MACHINE
K801900
Life Chiropractic College, Inc.
Physical Medicine · 32d
Cleared Sep 09, 1980
INSULATING SHEATH
K801910 · DXY
Cordis Corp.
Cardiovascular · 29d
Cleared Sep 09, 1980
HI-LO TEMP GEN. PURPOSE TEMP. PROBE
K801924 · FLL
National Catheter Co. Div. Mallinckrodt
General Hospital · 28d
Cleared Sep 09, 1980
SIGMA PROCEDURE #880 FIBRINOGIN/PLASMA
K801926 · KQJ
Sigma Chemical Co.
Hematology · 28d
Cleared Sep 09, 1980
IVAC 811Y ELEC. CLINICAL THERMOMETER
K801930 · FLL
Y
General Hospital · 28d
Cleared Sep 09, 1980
HEP-TROL
K801932 · GGW
Helena Laboratories
Hematology · 28d
Cleared Sep 09, 1980
RHINOMETER
K801938 · JYJ
Aztec Medical Products, Inc.
Ear, Nose, Throat · 28d
Cleared Sep 09, 1980
BRAIN HEART INFUSION MICROBIOLOGICAL
K801943 · JSG
Radiation Technology, Inc.
Microbiology · 26d
Cleared Sep 09, 1980
RIONET HEARING AID HB-70H
K801958 · ESD
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 48d
Cleared Sep 09, 1980
LITTLE GIANT I & II HANDPIECE CONTROL
K801975 · EIA
Silverman'S
Dental · 21d
Cleared Sep 09, 1980
SPOR-TEST CULTURE MEDIA
K801980 · JSG
Mdt Corp., Inc.
Microbiology · 21d
Cleared Sep 09, 1980
FE-3000 FETAL ELECTRODE, SPIRAL SYSTEM
K801984 · HGP
Life Support, Inc.
Obstetrics & Gynecology · 21d
Cleared Sep 09, 1980
BIO-MED CORP. DISP. NON-STERILE TRANSDU
K801985 · DRS
Bio-Med Corp.
Cardiovascular · 21d
Cleared Sep 09, 1980
ELASTIC BANDAGE CAT.#182-186 (WIDTH)
K801990 · FQM
Pollak (Intl.), Ltd.
General Hospital · 20d
Cleared Sep 09, 1980
EYE PADS CAT.#581-599
K801995 · HMP
Pollak (Intl.), Ltd.
General & Plastic Surgery · 20d
Cleared Sep 09, 1980
EMBOSSED DISP. POLY. GLOVES #5101-03
K801997 · FMC
Pollak (Intl.), Ltd.
General Hospital · 20d
Cleared Sep 09, 1980
STERILE EXAMINATION GLOVE #5121-5126
K801998 · FMC
Pollak (Intl.), Ltd.
General Hospital · 20d
Cleared Sep 09, 1980
URINE SPECIMEN CONTAINER #'S 1013-1016
K802002 · FMH
Pollak (Intl.), Ltd.
General Hospital · 20d
Cleared Sep 09, 1980
PLASTIC DISPOSABLE RAZOR CAT.#1017,1018
K802003 · LDQ
Pollak (Intl.), Ltd.
General & Plastic Surgery · 20d
Cleared Sep 09, 1980
BREAKING CAST WIRE CAT.#1112-1115
K802008
Pollak (Intl.), Ltd.
Physical Medicine · 20d
Cleared Sep 09, 1980
TRIBAG, URINE BAG SYSTEM #1109,& 1301-12
K802012 · KNX
Pollak (Intl.), Ltd.
Gastroenterology & Urology · 20d