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
119929–119952 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 06, 1991
VISIONPRO
K912177 · KPS
Trionix Research Laboratory, Inc.
Radiology · 113d
Cleared Sep 06, 1991
MEDITRON COMBINATION GENERATOR CG-2000
K912182 · GEI
Medical Devices, Inc.
General & Plastic Surgery · 113d
Cleared Sep 06, 1991
THE REMOTE
K912323 · IZL
Remote Technologies, Inc.
Radiology · 105d
Cleared Sep 06, 1991
HYPOALLERGENIC EXAMINATION LATEX GLOVES
K912503 · LYY
Medigloves , Ltd.
General Hospital · 113d
Cleared Sep 06, 1991
TAICHI STICK MASSAGER
K912512 · LYG
Focus International, Inc.
Physical Medicine · 92d
Cleared Sep 06, 1991
KTP/YAG PLUS
K912538 · GEX
Laserscope
General & Plastic Surgery · 88d
Cleared Sep 06, 1991
AVI MICRO 210D INFUSION PUMP
K912591 · FRN
3M Avi, Inc.
General Hospital · 88d
Cleared Sep 06, 1991
AXIOM ELECTROMYOGRAPH
K912595 · HCC
The Computerist, Inc.
Neurology · 88d
Cleared Sep 06, 1991
ELECTROSURGICAL ELECTRODE
K912597 · GEI
Megadyne Medical Products, Inc.
General & Plastic Surgery · 88d
Cleared Sep 06, 1991
SOUND RELIEF
K912659 · IRO
Windmere Corp.
Physical Medicine · 81d
Cleared Sep 06, 1991
ENZYME LINEARITY CONTROL
K912718 · JJY
Phoenix Diagnostics, Inc.
Chemistry · 80d
Cleared Sep 06, 1991
PHILIPS TOMOSCAN SR
K912752 · JAK
Philips Medical Systems North...
Radiology · 77d
Cleared Sep 06, 1991
HAZEL
K912855 · IOQ
Kinetic Concepts, Inc.
Physical Medicine · 70d
Cleared Sep 06, 1991
GE MR MAX
K912881 · LNH
GE Medical Systems
Radiology · 67d
Cleared Sep 06, 1991
MAY HUMERUS PLATES
K912936 · HRS
Turnkey Intergration USA, Inc.
Orthopedic · 63d
Cleared Sep 06, 1991
TRIANGULAR BANDAGE,40
K912949 · NAB
Cal West Trading Co.
General & Plastic Surgery · 61d
Cleared Sep 06, 1991
API UNISCEPT KB
K912965 · JWY
Analytab Products, Inc.
Microbiology · 60d
Cleared Sep 06, 1991
PLUME MASTER
K913036 · FYD
Sorex Medical
General Hospital · 59d
Cleared Sep 06, 1991
SHARPLAN SHARPLASE FAMILY ND:YAG SCULPTED FIBERS
K913037 · GEX
Sharplan Lasers, Inc.
General & Plastic Surgery · 59d
Cleared Sep 06, 1991
THYROID UPTAKE SYST/AUTOMLAB 900 MEDI SPEC 187-900
K913055 · IZD
Atomic Products Corp.
Radiology · 59d
Cleared Sep 06, 1991
VOLUMETRIC INFUSION PUMP, MODIFICATION
K913056 · FRN
Mcgaw, Inc.
General Hospital · 66d
Cleared Sep 06, 1991
IMPLANTABLE METAL STAPLES
K913139 · GDW
Ethicon, Inc.
General & Plastic Surgery · 52d
Cleared Sep 06, 1991
ID-TAB
K913160 · EGZ
Nix Co. , Ltd.
Dental · 51d
Cleared Sep 06, 1991
SALIBAG
K913168 · EGZ
Nix Co. , Ltd.
Dental · 51d