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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
82489–82512 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 05, 2000
ENZYME IMMUNOASSAY ANTI-CENTROMERE ANTIBODY TEST
K000489 · LLL
Helix Diagnostics, Inc.
Immunology · 51d
Cleared Apr 05, 2000
COBAS INTEGRA REAGENT CASSETTE FOR RHEUMATOID FACTOR II
K000534 · DHR
Roche Diagnostics Corp.
Immunology · 48d
Cleared Apr 05, 2000
DIMENSION PENTA L
K000595 · ELW
Espe Dental AG
Dental · 43d
Cleared Apr 05, 2000
FLEXTIME
K000629 · ELW
Heraeus Kulzer, Inc.
Dental · 41d
Cleared Apr 05, 2000
HWA (AND) SILKTEX POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELING...
K000725 · LYY
Hwa Teh Industrial Sdn. Bhd.
General Hospital · 30d
Cleared Apr 05, 2000
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR
K000872 · LYZ
Shanghai Antares Industries, Inc.
General Hospital · 16d
Cleared Apr 05, 2000
SKYLIGHT IMAGING SYSTEM
K000908 · KPS
Adac Laboratories
Radiology · 15d
Cleared Apr 05, 2000
LUXAFORM
K000951 · EBG
Dmg USA, Inc.
Dental · 13d
Cleared Apr 05, 2000
ARCHITECH AFP MASTERCHECK, MODEL 6C01-05
K992781 · JJX
Bio-Rad
Immunology · 230d
Cleared Apr 04, 2000
RENAFLO II HF 2000 HEMOFILTER
K000028 · KDI
Minntech Corp.
Gastroenterology & Urology · 90d
Cleared Apr 04, 2000
STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45...
K000029 · DTB
Ela Medical, Inc.
Cardiovascular · 90d
Cleared Apr 04, 2000
SUNI MAX
K000049 · EFB
Satelec
Dental · 88d
Cleared Apr 04, 2000
PROVEN KNEE SYSTEM
K000113 · JWH
Stelkast Company
Orthopedic · 81d
Cleared Apr 04, 2000
MEDISUL DISPOSABLE VAGINAL SPECULUM
K000414 · HIB
Marketing Perspectives
Obstetrics & Gynecology · 56d
Cleared Apr 04, 2000
MS-ONE, MODEL MS-1
K994065 · IPF
Home Wellness West
Physical Medicine · 125d
Cleared Apr 03, 2000
INSUFFLATION NEEDLE, MODEL R65-933
K000027 · HIF
A & A Medical, Inc.
Obstetrics & Gynecology · 89d
Cleared Apr 03, 2000
ASNIS III CANNULATED SCREW SYSTEM
K000080 · HWC
Howmedica Osteonics Corp.
Orthopedic · 83d
Cleared Apr 03, 2000
BOHN FEMORAL COMPONENT
K000262 · MEH
Biomet Manufacturing, Inc.
Orthopedic · 66d
Cleared Apr 03, 2000
URINE BARBITURATES (BARB) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 96A
K000459 · DIS
Dade Behring, Inc.
Toxicology · 52d
Cleared Apr 03, 2000
RANDOX FERRITIN
K000662 · DBF
Randox Laboratories, Ltd.
Immunology · 35d
Cleared Apr 03, 2000
OBL 2.0 MM MINI TAC ANCHOR, MODEL 10-1629-01
K000797 · JDR
Orthopaedic Biosystems, Ltd.
Orthopedic · 21d
Cleared Apr 03, 2000
WEHRS INCUS-STAPES
K000858 · ETB
Gyrus Ent LLC
Ear, Nose, Throat · 18d
Cleared Apr 03, 2000
RAPIDONE- BARBITURATE TEST
K992451 · DIS
American Bio Medica Corp.
Toxicology · 256d
Cleared Apr 03, 2000
RAPIDONE- BENZODIAZEPINE TEST
K992720 · JXM
American Bio Medica Corp.
Toxicology · 234d