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
131977–132000 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 14, 1989
VITALON MATRESS MASSAGE MODEL M-MX
K890923 · ISA
Nexus Co. , Ltd. C/O Yama Trans Co. ,...
Physical Medicine · 18d
Cleared Mar 14, 1989
THERMO-PACK
K890924 · IMD
Medical Manufacturers, Inc.
Physical Medicine · 18d
Cleared Mar 14, 1989
STERILE PATIENT EXAMINATION GLOVE
K891103 · LYY
Boston Medical Corp.
General Hospital · 25d
Cleared Mar 13, 1989
PROGENE MICROALBUMINURIA SCREEN
K882538 · JIR
Progene Corp.
Chemistry · 265d
Cleared Mar 13, 1989
AEGIS(TM) CONDOMS
K883409 · HIS
Green Cross Medical Supplies Corp.
Obstetrics & Gynecology · 210d
Cleared Mar 13, 1989
ROS-TR SYSTEM
K884140 · DZE
Ross Systems C/O...
Dental · 164d
Cleared Mar 13, 1989
EDWARDS DISPOSABLE ARTHROSCOPY CANNULA
K884301 · HRX
Baxter Healthcare Corp
Orthopedic · 151d
Cleared Mar 13, 1989
LEONARD MEDICAL 1.7MM ARTHROSCOPE
K884314 · HRX
Leonard Medical, Inc.
Orthopedic · 151d
Cleared Mar 13, 1989
RELLPLATE C KIT, RELLPLATE C BULK PLATES
K884940 · GGP
American Diagnostic Corp.
Hematology · 105d
Cleared Mar 13, 1989
ACTICLOT C KIT
K884941 · GGP
American Diagnostic Corp.
Hematology · 105d
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