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
123385–123408 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 05, 1990
MICROMED QRS CARD
K903722 · DPS
Nasiff Assoc., Inc.
Cardiovascular · 112d
Cleared Dec 05, 1990
MODEL DH-1000 SINGLE DETEC./DUAL DETEC NUCL CAMERA
K904050 · IYX
Philips Medical Systems (Cleveland),...
Radiology · 92d
Cleared Dec 05, 1990
ENDOPATH UNSHIELDED DISPOSABLE SURGICAL TROCAR
K904104 · HET
Ethicon, Inc.
Obstetrics & Gynecology · 90d
Cleared Dec 05, 1990
GRASPING FORCEPS/ALIGATOR FORCEPS/NEEDLE HOLDERS
K904142 · HET
Baxter Healthcare Corp
Obstetrics & Gynecology · 89d
Cleared Dec 05, 1990
SITE 19 GAUGE ULTRASONIC I/A PHACO NEEDLE
K904151 · HQC
Site Microsurgical Systems, Inc.
Ophthalmic · 89d
Cleared Dec 05, 1990
SITE PHACOEMULSIFICATION HANDPIECE
K904183 · HQC
Site Microsurgical Systems, Inc.
Ophthalmic · 84d
Cleared Dec 05, 1990
HORIZON REGULAR ETCHING GEL
K904199 · EJR
Horizon Chemical Co.
Dental · 84d
Cleared Dec 05, 1990
ARTHROSCOPIC SURGICAL BLADE
K904284 · HRX
Smith & Nephew Dyonics, Inc.
Orthopedic · 79d
Cleared Dec 05, 1990
LYSTA HYGIENIST III SCALER
K904296 · ELC
Prodent Intl., Inc.
Dental · 77d
Cleared Dec 05, 1990
CHEMOSITE IMPLANTABLE DRUG DELIVERY SYSTEM
K904417 · LJT
Device Labs, Inc.
General Hospital · 69d
Cleared Dec 05, 1990
PRECISION HIP STEM WITH ADDITIONAL STEM SIZES
K904844 · JDI
Howmedica Corp.
Orthopedic · 41d
Cleared Dec 05, 1990
EYE PAD
K904896 · HMP
Ulti-Med Intl., Inc.
General & Plastic Surgery · 36d
Cleared Dec 05, 1990
PROXIMAL FEMUR REPLACEMENT STEM
K904919 · JDI
Depuy, Inc.
Orthopedic · 35d
Cleared Dec 05, 1990
STERI-VAC(TM) AERATOR MODEL XL
K904921 · FLI
3M Health Care, Ltd.
General Hospital · 35d
Cleared Dec 05, 1990
DPX-L AND DPX-ALPHA, MODIFICATION
K904980 · KGI
Lunar
Radiology · 33d
Cleared Dec 04, 1990
NEURITOR 2001
K902752 · GWQ
Imexco General , Ltd.
Neurology · 165d
Cleared Dec 04, 1990
LATEX EXAMINATION GLOVES
K902796 · LYY
Ek Hong Rubber Industry (Thailand)...
General Hospital · 161d
Cleared Dec 04, 1990
TRANSTAT-CMV(TM)
K903308 · LFX
Ab Sangtec Medical
Microbiology · 133d
Cleared Dec 04, 1990
VARICELLA-ZOSTER VIRUS ANTIBODY TEST KIT-LATEX AGG
K903882 · GQW
Viral Antigens, Inc.
Microbiology · 104d
Cleared Dec 04, 1990
MTE-T RADIOGRPHIC/TOMOGRAPHIC ELEVATING TABLE
K903921 · IZZ
Imt America, Inc.
Radiology · 102d
Cleared Dec 04, 1990
RUBELLA IGM ELISA TEST
K904084 · LFX
Gull Laboratories, Inc.
Microbiology · 90d
Cleared Dec 04, 1990
COSPAN CONTINUOUS SPINAL ANESTHESIA TRAY
K904101 · CAZ
Kendall Healthcare Products Co....
Anesthesiology · 89d
Cleared Dec 04, 1990
SINGLE LUMEN CATHETER KITS
K904139 · LFJ
Akcess Medical Products, Inc.
Gastroenterology & Urology · 89d
Cleared Dec 04, 1990
FLEXISYS
K904149 · GEX
Dornier Medtech America, Inc.
General & Plastic Surgery · 88d