FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
132577–132600 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 13, 1989
LIPASE SR LIQUID STABLE REAGENT SET
K885078 · CET
Medical Analysis Systems, Inc.
Chemistry · 95d
Cleared Mar 13, 1989
RAPID DIAG. SYSTEM FOR MYCOBACTERIUM GORDONAE
K890089 · LQF
Gen-Probe, Inc.
Microbiology · 62d
Cleared Mar 13, 1989
20/20 ORTHODONTIC CERAMIC BRACKET
K890145 · EJF
American Orthodontics
Dental · 59d
Cleared Mar 13, 1989
FLORIDA PROBE PERIODONTAL PROBE
K890493 · EIL
Florida Probe Corp.
Dental · 41d
Cleared Mar 13, 1989
IMPRES-MB REAGENT A AND REAGENT B
K890543 · JHX
Intl. Immunoassay Laboratories, Inc.
Chemistry · 38d
Cleared Mar 13, 1989
HI CHEM CALIBRATION STANDARDS LEVELS 1 AND 2
K890583 · JIX
Hichem Diagnostics
Chemistry · 35d
Cleared Mar 13, 1989
OMNIFIT UHMWPE ACETABULAR SHELL CEMENT SPACE SYST.
K890649 · JDI
Osteonics Corp.
Orthopedic · 33d
Cleared Mar 13, 1989
ABUSCREEN FP FOR COCAINE METABOLITE
K890885 · DIO
Roche Diagnostic Systems, Inc.
Toxicology · 20d
Cleared Mar 13, 1989
SHARPLAN MODEL 2106
K891016 · GEX
Sharplan Lasers, Inc.
General & Plastic Surgery · 13d
Cleared Mar 10, 1989
MUSCLE STIM. DEVICES, BM 2000,4000,6000,8000
K874232 · IPF
Health Systems Intl., Inc.
Physical Medicine · 512d
Cleared Mar 10, 1989
SOKEN PLUS(TM) ELECTRONIC MUSCLE STIMULATOR
K881470 · IPF
Rehab Medical Specialties, Inc.
Physical Medicine · 337d
Cleared Mar 10, 1989
VENA CAVA FILTER
K881604 · DTK
Vena-Tech, Inc.
Cardiovascular · 332d
Cleared Mar 10, 1989
VIRGO HSV-2 IGG ELISA
K883281 · GQO
Electro-Nucleonics, Inc.
Microbiology · 219d
Cleared Mar 10, 1989
VIRGO HSV-1 IGG ELISA
K883282 · GQO
Electro-Nucleonics, Inc.
Microbiology · 219d
Cleared Mar 10, 1989
VIRGO(R) VZV-IGG ELISA
K883427 · GQX
Electro-Nucleonics, Inc.
Microbiology · 207d
Cleared Mar 10, 1989
AUDIOSCOPE 3 MODEL 23300 ACCESSORIES
K884218 · EWO
Welch Allyn, Inc.
Ear, Nose, Throat · 155d
Cleared Mar 10, 1989
EXTRA STRENGTH SKIN LESS SKIN CONDOM
K884402 · HIS
Okamoto USA, Inc.
Obstetrics & Gynecology · 142d
Cleared Mar 10, 1989
CLINISTAT CHOLESTEROL REAGENT TEST
K884757 · CHH
Heraeus Kulzer, Inc.
Chemistry · 116d
Cleared Mar 10, 1989
F40 K KARAYA GUM DISP. PE-FOAM ECG ELECTRODE, 40MM
K884981 · DRX
S & W Medico Teknik
Cardiovascular · 101d
Cleared Mar 10, 1989
M68 K KARAYA GUM DISP. MICROTAPE ECG ELECTRODE,68
K884982 · DRX
S & W Medico Teknik
Cardiovascular · 101d
Cleared Mar 10, 1989
BARIUM ENEMA TUBES: NO. 3001000, 3001001, 3001002
K885092 · KPL
Medical Imaging Systems, Inc.
Gastroenterology & Urology · 88d
Cleared Mar 10, 1989
STANDARD, TUOHY BORST & DUAL VALVE Y-CONNECTOR
K885247 · LIT
Baxter Healthcare Corp
Cardiovascular · 78d
Cleared Mar 10, 1989
HEMOSTASIS VALVE, WITH OR WITHOUT SIDE PORT
K890277 · DYB
Oscor Medical Corp.
Cardiovascular · 51d
Cleared Mar 10, 1989
CARDIOTOMY/AUTOTRANSFUSION/PLEURAL DRAINAGE VENOUS
K890504 · JOD
Gish Biomedical, Inc.
Cardiovascular · 37d