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

Filters: Cleared only ×
175,820 results
107761–107784 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 17, 1994
FLOWGUN ELECTROCAUTERY PROBES
K941337 · GEI
O.R. Concepts, Inc.
General & Plastic Surgery · 149d
Cleared Aug 17, 1994
MILL ROSE ERCP CANNULAS
K941401 · GCJ
Mill-Rose Lab, Inc.
General & Plastic Surgery · 148d
Cleared Aug 17, 1994
PROVIPONT C&B
K941849 · EBG
Ivoclar USA, Inc.
Dental · 125d
Cleared Aug 17, 1994
IMPLANTECH DORSAL COLUMELLA IMPLANT STYLE II
K941960 · FZE
Implantech Associates, Inc.
General & Plastic Surgery · 117d
Cleared Aug 17, 1994
VIDEO PLUS WITH ANALYTICAL WORKSTATION
K941979 · IZI
Camtronics, Ltd.
Radiology · 114d
Cleared Aug 17, 1994
LINEAR TOMOGRAPHIC SYSTEM: PMT 6000
K942175 · IZF
Continental X-Ray Corp.
Radiology · 105d
Cleared Aug 17, 1994
ID100 MOBILE FLUOROSCOPIC EXAMINING TABLE
K942190 · IXQ
Image Diagnostics, Inc.
Radiology · 105d
Cleared Aug 17, 1994
KYOKKO GREEN SERIES INTENSIFYING SCREENS
K942235 · EAM
Fujifilm Medical System U.S.A., Inc.
Radiology · 100d
Cleared Aug 17, 1994
DUPONT APC BLOOD COLLECTION CONTAINER WITH LITHIUM HEPARIN
K942240 · JKA
Dupont Medical Products
Chemistry · 100d
Cleared Aug 17, 1994
TAS-(VARIOUS) ULTRATHIN FLEXIBLE ENDOSCOPE
K942388 · EOQ
Technology Marketing Group
Ear, Nose, Throat · 90d
Cleared Aug 17, 1994
INFUSION CANNULA
K942403 · HMX
Microsurgical Technology, Inc.
Ophthalmic · 90d
Cleared Aug 17, 1994
2 MICRON AIR ELIMINATING FILTER
K942532 · FPB
Medi-Dose, Inc.
General Hospital · 82d
Cleared Aug 17, 1994
MIRACLE-EAR MODEL PGF + REMOTE
K942893 · ESD
Miracle-Ear/Dahlberg, Inc.
Ear, Nose, Throat · 58d
Cleared Aug 17, 1994
MIRACLE-EAR MODEL PGC
K942894 · ESD
Miracle-Ear/Dahlberg, Inc.
Ear, Nose, Throat · 58d
Cleared Aug 17, 1994
MIRACLE EAR MODEL PGM
K942895 · ESD
Miracle-Ear/Dahlberg, Inc.
Ear, Nose, Throat · 58d
Cleared Aug 17, 1994
INTERACOUSTICS CLINICAL AUDIOMETER
K943065 · EWO
Precision Acoustics Ind., Inc.
Ear, Nose, Throat · 50d
Cleared Aug 17, 1994
MAGNEFORCE
K943068 · ECO
Ormco Corp.
Dental · 50d
Cleared Aug 17, 1994
MEDNEXT MICRO-DRILL
K943108 · ERL
Mednext, Inc.
Ear, Nose, Throat · 49d
Cleared Aug 17, 1994
SUNGLASSES (NON-PRESCRIPTION)
K943377 · HQY
Carol Wright Sales
Ophthalmic · 35d
Cleared Aug 17, 1994
STYLE I WRAPPER SUNGLASSES
K943405 · HQY
Plastic, Inc.
Ophthalmic · 34d
Cleared Aug 17, 1994
FUJI HG-M INTENSIFYING SCREEN
K943425 · EAM
Fujifilm Medical System U.S.A., Inc.
Radiology · 33d
Cleared Aug 17, 1994
RSX-525HF
K943504 · IZO
Fischer Imaging Corp.
Radiology · 28d
Cleared Aug 17, 1994
BAXTER ONE GALLON SHARPS DISPOSAL CONTAINERS
K943594 · FMI
Baxter Healthcare Corp
General Hospital · 23d
Cleared Aug 17, 1994
BAXTER TWO GALLON SHARPS DISPOSAL CONTAINERS
K943605 · FMI
Baxter Healthcare Corp
General Hospital · 23d