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
107449–107472 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 13, 1994
F-220 PRESS-FIT FEMORAL HIP STEM SYSTEM
K935990 · MEH
Implex Corp.
Orthopedic · 211d
Cleared Jul 13, 1994
CHEMTRAK LIQUID UNASSAYED THERAPEUTIC DRUG CONTROLS
K936166 · DIF
Medical Analysis Systems, Inc.
Toxicology · 203d
Cleared Jul 13, 1994
DIGOXIN FPIA REAGENT SET AND CALIBRATOR SET
K940569 · KXT
Sigma Diagnostics, Inc.
Chemistry · 155d
Cleared Jul 13, 1994
QUICK CORE II
K941256 · KNW
Proact, Ltd.
Gastroenterology & Urology · 121d
Cleared Jul 13, 1994
EMC FLEXIBLE BIOPSY FORCEPS
K941816 · FCL
Enterprise Medical Corp.
Gastroenterology & Urology · 91d
Cleared Jul 13, 1994
DRAGER DVE 8000/1/2 SERIES SYST W/DVE 4002 AND 8032E
K942043 · FQO
Alm Surgical Equipment, Inc.
General & Plastic Surgery · 76d
Cleared Jul 13, 1994
SR1 DHEA-S ENZYME IMMUNOASSAY
K942051 · JKC
Serono Diagnostics, Inc.
Toxicology · 76d
Cleared Jul 13, 1994
THEOPHYLLINE FPIA REAGENT SET AND CALIBRATORS
K942192 · LER
Sigma Diagnostics, Inc.
Chemistry · 70d
Cleared Jul 13, 1994
ADJUSTABLE BITE CORRECTOR
K942492 · ECO
Orthoplus, Inc.
Dental · 49d
Cleared Jul 13, 1994
AIRFRAME SURGICAL DRAPE SUPPORT
K942699 · BWN
Alpha Surgical, Inc.
General & Plastic Surgery · 35d
Cleared Jul 13, 1994
DISPOSABLE BACTERIOLOGICAL FILTER
K942779 · BZG
Vitalograph, Inc.
Anesthesiology · 30d
Cleared Jul 13, 1994
CONMED SELECT-ONE LAPAROSCOPIC ELECTROSURGICAL BLADE
K942892 · GEI
Conmedcorp
General & Plastic Surgery · 23d
Cleared Jul 12, 1994
HYDROXYLAPATITE COATED SABER TECH SERIES I & SERIES II
K924112 · DZE
Saber Technology, Inc.
Dental · 718d
Cleared Jul 12, 1994
BIOSIGN(TM_ RUBELLA - RUBELLA ANTIBODY TEST
K925355 · LFX
Princeton Biomedix
Microbiology · 628d
Cleared Jul 12, 1994
NON-PRESCRIPTION SUNGLASSES
K925596 · HQY
European & Foreign Imports, Inc.
Ophthalmic · 614d
Cleared Jul 12, 1994
LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)
K926597 · HET
Optimed Technologies, Inc.
Obstetrics & Gynecology · 809d
Cleared Jul 12, 1994
HOOKING SYSTEM
K930613 · LYG
Alain Machtelinckx
Physical Medicine · 522d
Cleared Jul 12, 1994
RESTORE HEX CYLINDER ENDOSSEOUS SYSTEM
K931468 · DZE
Lifecore Biomedical, Inc.
Dental · 475d
Cleared Jul 12, 1994
THE SIGNATURE SERIES, IC II
K933196 · IPF
Progressive Electrical Therapeutics
Physical Medicine · 376d
Cleared Jul 12, 1994
DEPUY MOTECH MOSS-MIAMI SPINAL SYSTEM
K933881 · KWP
Depuy, Inc.
Orthopedic · 336d
Cleared Jul 12, 1994
OGDEN ANCHOR (MODIFICATION)
K935167 · JDR
American Medical Electronics, Inc.
Orthopedic · 258d
Cleared Jul 12, 1994
ISOCOMFORTER
K936143 · ILO
Isocomforter, Inc.
Physical Medicine · 197d
Cleared Jul 12, 1994
GALILEO ARTHROSCOPES
K936280 · HRX
Galileo Electro-Optics Corp.
Orthopedic · 284d
Cleared Jul 12, 1994
TITANIUM ALLOY BONE SCREWS
K940207 · HWC
Aesculap, Inc.
Orthopedic · 179d