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
123961–123984 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 06, 1990
GUIDEWIRE
K904477 · DQX
Datascope Corp.
Cardiovascular · 66d
Cleared Dec 06, 1990
ANSWER QUICK AND SIMPLE AT-HOME PREGNANCY TEST
K904782 · LCX
Carter Products
Chemistry · 45d
Cleared Dec 06, 1990
SHUR-LOCK ICE WRAP SYSTEM
K904819 · IMD
Conco Medical Co.
Physical Medicine · 43d
Cleared Dec 06, 1990
ACS CHOLESTEROL/TRIGLYCERIDE LIQUID CONTROL
K904829 · JJY
Analytical Control Systems, Inc.
Chemistry · 42d
Cleared Dec 06, 1990
QCLYTE PROTEIN BASED ISE CONTROL
K904968 · JJY
Baxter Healthcare Corp
Chemistry · 31d
Cleared Dec 06, 1990
ELEGANCE GH ELISA
K905098 · CFL
Bioclone Australia Pty , Ltd.
Chemistry · 23d
Cleared Dec 06, 1990
SYSTEM 90 AND 95
K905293 · ITI
Folio Products, Inc.
Physical Medicine · 13d
Cleared Dec 05, 1990
MIC PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBE
K900464 · KNT
Medical Innovations Corp.
Gastroenterology & Urology · 308d
Cleared Dec 05, 1990
37-702 AND 37-703 PC RAINBOW
K900932 · IYI
Victoreen, Inc.
Radiology · 280d
Cleared Dec 05, 1990
ADVANCE DISPOSABLE STOPCOCK
K902724 · FMG
Advance Medical Designs, Inc.
General Hospital · 167d
Cleared Dec 05, 1990
DISPOSABLE EMISSIONS BARRIER LASER DRAPE
K903346 · KKX
Wave-Form Systems, Inc.
General Hospital · 133d
Cleared Dec 05, 1990
VAS-CATH OPTI-PLAST 5F PERIPHERAL ANGIOPLASTY CATH
K903417 · LIT
Vas-Cath, Inc.
Cardiovascular · 127d
Cleared Dec 05, 1990
TSRH OFFSET AND SIDE-LOADING HOOKS
K903461 · KWP
Danek Medical, Inc.
Orthopedic · 126d
Cleared Dec 05, 1990
DENE BRIDGE
K903672 · EKO
Dirotian Pty. , Ltd.
Dental · 113d
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