FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
74449–74472 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 13, 2002
AGILTRAC .035 PERIPHERAL DILATATION CATHETER
K022738 · DQY
Guidant Corp.
Cardiovascular · 25d
Cleared Sep 13, 2002
MANUAL WHEELCHAIR
K022825 · IOR
Major Mobility Products, Inc.
Physical Medicine · 18d
Cleared Sep 13, 2002
GUIDANT PROXIMAL SEAL SYSTEM, MODELS PSS-4500 & PS-4500
K022880 · DXC
Guidant Corp.
Cardiovascular · 14d
Cleared Sep 12, 2002
ACQPLAN 5.0
K013644 · MUJ
Philips Medical Systems, Inc.
Radiology · 311d
Cleared Sep 12, 2002
BREAST BOLSTER
K020624 · IZH
Beekley Corp.
Radiology · 198d
Cleared Sep 12, 2002
FG-36UX FIBER ULTRASOUND GASTROSCOPE
K021276 · ODG
Pentax Precision Instrument Corp.
Radiology · 143d
Cleared Sep 12, 2002
HYBRID FS & HYBRID FS TORIC (HYCOFOCON A) RGP CONTACT LENS FOR DAILY WEAR
K021977 · HQD
Contamac, Ltd.
Ophthalmic · 87d
Cleared Sep 12, 2002
KAWASUMI LABORATORIES ANTINEEDLE STICK PROTECTOR FOR USE WITH PORT ACCESS...
K022110 · LJT
Kawasumi Laboratories, Inc.
General Hospital · 76d
Cleared Sep 12, 2002
DELTA 32
K022275 · IZH
Instrumentarium Corp. Imaging Division
Radiology · 59d
Cleared Sep 12, 2002
TMD SAFETY SYRINGE (FA12 SERIES 3ML/FA13 SERIES 5ML)
K022278 · MEG
Taiject Medical Device Co., Ltd.
General Hospital · 59d
Cleared Sep 12, 2002
IMPAX DIAGNOSTIC DISPLAY STATION,IMPAX CLINICAL REVIEW STATION,IMPAX FOR...
K022292 · LLZ
Agfa Corp.
Radiology · 59d
Cleared Sep 12, 2002
G-RINSE, MODEL 10031
K022295 · MQL
Vitrolife Sweden AB
Obstetrics & Gynecology · 58d
Cleared Sep 12, 2002
PORTA OP SOLDER W-2
K022454 · EJT
Wieland Dental + Technik GmbH & Co. KG
Dental · 48d
Cleared Sep 12, 2002
AUROPAL SOLDER M-1
K022459 · EJT
Wieland Dental + Technik GmbH & Co. KG
Dental · 48d
Cleared Sep 12, 2002
SURESTEP BLOOD GLUCOSE MONITORING SYSTEM
K022724 · NBW
Lifescan, Inc.
Chemistry · 27d
Cleared Sep 12, 2002
GE ROAD WARRIOR PET CT IMAGING SYSTEM
K022872 · KPS
General Electric Co.
Radiology · 14d
Cleared Sep 12, 2002
INION CPS 2.5/2.8 SCREW
K022981 · HWC
Inion , Ltd.
Dental · 3d
Cleared Sep 11, 2002
VIDENT HEXTOP, SYNOCTA IN-CERAM BLANK/COPING MANUFACTURED BY VIDENT
K012473 · DZE
Vident
Dental · 405d
Cleared Sep 11, 2002
MADETT
K021044 · BTR
Wolfe Tory Medical, Inc.
Anesthesiology · 163d
Cleared Sep 11, 2002
BIOSOMNIA
K021485 · OMC
Oxford Biosignals Limited
Neurology · 126d
Cleared Sep 11, 2002
RADIONICS POLE NEEDLES
K021942 · GXI
Radionics, A Division of Tyco...
Neurology · 90d
Cleared Sep 11, 2002
CELL ROBOTICS ULTRA-LIGHT PEEL LASER SYSTEM
K021946 · GEX
Cell Robotics, Inc.
General & Plastic Surgery · 90d
Cleared Sep 11, 2002
JOSTRA VENT CATHETERS, MODELS LV & HKV
K022022 · DWF
Jostra AG
Cardiovascular · 83d
Cleared Sep 11, 2002
SOUNDVASER SYSTEM
K022051 · QPB
Sound Surgical Technologies, LLC
General & Plastic Surgery · 79d