FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
165769–165792 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Sep 09, 1980
FINGER PAINGUARD CAT.#193-194
K802015 · FQM
Pollak (Intl.), Ltd.
General Hospital · 20d
Cleared Sep 09, 1980
PREP SET CAT.#908
K802020 · KXF
Pollak (Intl.), Ltd.
General Hospital · 20d
Cleared Sep 09, 1980
CULSWAB CAT.#978 & 979
K802023 · JTW
Pollak (Intl.), Ltd.
Microbiology · 20d
Cleared Sep 09, 1980
BATTERY FOR #229-01 PULSE GENERATOR
K802040 · DXY
Intermedics, Inc.
Cardiovascular · 29d
Cleared Sep 09, 1980
AMPCO SKIN SCRUB TRAYS, CAT.#SS612
K802044 · LDQ
Associated Medical Products Co.
General & Plastic Surgery · 21d
Cleared Sep 09, 1980
SOF-TOUCH NASAL CANNULA CAT.#304 & 305
K802062 · CAT
Hospitak, Inc.
Anesthesiology · 13d