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
119809–119832 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 27, 1991
REFURBISHED ORTHODONTIC APPLIANCES
K913913 · EJF
Ortho-Cycle Co.
Dental · 89d
Cleared Nov 27, 1991
DFC-1024 & DFC-512 DIGITAL IMAGING SYSTEM
K913929 · HKI
Ophthalmic Imaging Systems
Ophthalmic · 85d
Cleared Nov 27, 1991
ENDO I/A Y SET
K913979 · HIF
Snowden-Pencer
Obstetrics & Gynecology · 82d
Cleared Nov 27, 1991
MRT-150A
K914012 · LNH
Toshiba America Mri, Inc.
Radiology · 79d
Cleared Nov 27, 1991
NEEDLE*LOCK(TM) WITH INTERLINK(TM) INJECTION SITE
K914048 · FPA
Baxter Healthcare Corp
General Hospital · 78d
Cleared Nov 27, 1991
SUAN FLAT DISSECTOR SPONGES
K914082 · GDY
Icn Pharmaceuticals, Inc.
General & Plastic Surgery · 77d
Cleared Nov 27, 1991
PLASMA TFE SYNTHETIC ARTERY-CLARIFICATION
K914116 · DSY
Medtronic Vascular
Cardiovascular · 83d
Cleared Nov 27, 1991
CONNECTING SET
K914128 · DQO
Procedure Products, Inc.
Cardiovascular · 75d
Cleared Nov 27, 1991
P2020-8-0 BEAM-LIMITING DEVICE
K914184 · KPW
Precise Optics
Radiology · 70d
Cleared Nov 27, 1991
BARD SINGULAR BIOPSY FORCEPS
K914212 · FCL
C.R. Bard, Inc.
Gastroenterology & Urology · 69d
Cleared Nov 27, 1991
MICRO-X 50 HF
K914236 · IZO
Fischer Imaging Corp.
Radiology · 68d
Cleared Nov 27, 1991
MICRO-X 30 HF
K914266 · IZO
Fischer Imaging Corp.
Radiology · 65d
Cleared Nov 27, 1991
CEQUAL(TM) QUANITATIVE ANALYSIS CARDIOLITE(R) SPEC
K914296 · KPS
Nuccardiac Software, Inc.
Radiology · 63d
Cleared Nov 27, 1991
HICOR
K914313 · IZI
Siemens Gammasonics, Inc.
Radiology · 65d
Cleared Nov 27, 1991
DRILL MODULES MODELS 2116/2117
K914346 · ERL
Micro Surgical Instruments Corp.
Ear, Nose, Throat · 61d
Cleared Nov 27, 1991
UNIVERSAL GENERAL USE KIT #7-510-16
K914401 · HIF
Northgate Technologies, Inc.
Obstetrics & Gynecology · 56d
Cleared Nov 27, 1991
RECIRCULATION KIT #7-510-18
K914402 · HIF
Northgate Technologies, Inc.
Obstetrics & Gynecology · 56d
Cleared Nov 27, 1991
GENERAL USE KIT #7-510-20
K914403 · HIF
Northgate Technologies, Inc.
Obstetrics & Gynecology · 56d
Cleared Nov 27, 1991
ENTREE NEEDLE
K914426 · FHO
Core Dynamics, Inc.
Gastroenterology & Urology · 56d
Cleared Nov 27, 1991
COULTER CARBON DIOXIDE REAGENT
K914486 · KHS
Coulter Corp.
Chemistry · 50d
Cleared Nov 27, 1991
POWDER FREE, NON-STERILE, LATEX EXAMINATION GLOVES
K914498 · LYY
Medmark, Inc.
General Hospital · 50d
Cleared Nov 27, 1991
DIMENSION(R) LACTIC ACID METHOD
K914508 · KHP
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 49d
Cleared Nov 27, 1991
TECHNICON AXON(TM) SYSTEM METHODS ANYALYE HDL CHOL
K914511 · LBS
Technicon Instruments Corp.
Chemistry · 49d
Cleared Nov 27, 1991
MODEL 311GE-64: WHOLE VOLUME NECK COIL
K914535 · LNH
Medical Advances, Inc.
Radiology · 47d