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
119089–119112 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 13, 1991
BATEMAN UPF-III BIPOLAR ENDOPROSTHESIS SYSTEM
K913632 · KWY
Kirschner Medical Corp.
Orthopedic · 90d
Cleared Nov 13, 1991
MODULAR CALCAR REPLACEMENT
K913649 · JDI
Zimmer, Inc.
Orthopedic · 89d
Cleared Nov 13, 1991
NELLCOR(R) N-180 PULSE OXIMETER
K913695 · DQA
Nellcor, Inc.
Anesthesiology · 86d
Cleared Nov 13, 1991
ARGEBOND 80
K913704 · EJS
Argen Precious Metals, Inc.
Dental · 86d
Cleared Nov 13, 1991
ULTRACROWN(TM) PD ALLOY POST-SOLDER
K913860 · EJS
Dentsply Intl.
Dental · 78d
Cleared Nov 13, 1991
RICH-MAR MODEL II ULTRASOUND
K913981 · IMI
Rich-Mar Corp.
Physical Medicine · 68d
Cleared Nov 13, 1991
MDT/CASTLE 2000 SURGICAL LIGHTS
K914076 · FSY
Mdt Corp., Inc.
General & Plastic Surgery · 63d
Cleared Nov 13, 1991
LANDERS HIGH REFRACTIVE INDEX VITRECTOMY LENS SET
K914117 · HJK
Ocular Instruments, Inc.
Ophthalmic · 61d
Cleared Nov 13, 1991
DUOMAT 3 AMALGAMATOR
K914340 · EFD
Degussa AG
Dental · 47d
Cleared Nov 13, 1991
MIXOMAT AMALGAMATOR
K914341 · EFD
Degussa AG
Dental · 47d
Cleared Nov 13, 1991
PART 872 DEGUFILL H & DEGUFILL M DA
K914368 · EKJ
Degussa AG
Dental · 43d
Cleared Nov 13, 1991
MEDICAL DESIGNS REUSABLE CARBON RUBBER ELECTRODE
K914384 · GXY
Medical Design & Manufacturing Corp.
Neurology · 43d
Cleared Nov 13, 1991
BACK MASTER
K914394 · BXB
Progressive Electrical Therapeutics
Physical Medicine · 43d
Cleared Nov 13, 1991
SOFTSHIELD(TM) 12, 24, 72 COLLAGEN CORNEAL SHIELDS
K914529 · MOE
Oasis Medical, Inc.
Ophthalmic · 33d
Cleared Nov 13, 1991
PLATINUM FOIL PLATINUM MILING WAFER
K914627 · EJS
Metalor Dental USA Corp.
Dental · 28d
Cleared Nov 13, 1991
MEDIX BIOTECH TOTAL HCG ENZY IMMUN TEST KT DIF4011
K914696 · JHI
Medix Biotech, Inc.
Chemistry · 26d
Cleared Nov 13, 1991
MDT/CASTLE PURUS DENTAL UNIT
K914697 · EIA
Mdt Corp., Inc.
Dental · 26d
Cleared Nov 13, 1991
CLA-1400 SYSTEM
K914851 · IOQ
Gaymar Industries, Inc.
Physical Medicine · 16d
Cleared Nov 08, 1991
DANBY D.S.P. SYRINGE PUMP
K911103 · FRN
Isys Medical , Ltd.
General Hospital · 241d
Cleared Nov 08, 1991
HELIX SHAPED COILS WITH DACRON FIBERS, MODIFIED
K911779 · HCG
Target Therapeutics
Neurology · 210d
Cleared Nov 08, 1991
SAPPHIRE 4ME EMG/EP SYSTEM
K912775 · GWF
Medelec Intl. Corp.
Neurology · 137d
Cleared Nov 08, 1991
HELIX SHAPED COILS WITH DACRON FIBERS, MODIFIED
K913312 · HCG
Target Therapeutics
Neurology · 106d
Cleared Nov 08, 1991
TOTAL IRON AND UNSAT IRON BIND CAPAC/IRON BIND CAL
K913371 · JIT
Creative Laboratory Products, Inc.
Chemistry · 102d
Cleared Nov 08, 1991
ORIGINEEDLE, MODIFICATION
K913816 · FHO
Origin Medsystems, Inc.
Gastroenterology & Urology · 74d