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
73921–73944 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 13, 2002
RICH-MAR THERASOUND 6.5 THERAPEUTIC ULTRASOUND
K021483 · IMI
Rich-Mar Corp.
Physical Medicine · 128d
Cleared Sep 13, 2002
BINAX NOW RSV TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN...
K021687 · GQG
Binax, Inc.
Microbiology · 114d
Cleared Sep 13, 2002
LASERSYSTEM BEAUTYSTAR 532
K021975 · GEX
Asclepion-Meditec AG
General & Plastic Surgery · 88d
Cleared Sep 13, 2002
SELECTOR INTEGRA ULTRASONIC SURGICAL ASPIRATOR, MODEL OM 1530000M3
K021989 · LFL
Integra Neurosciences
General & Plastic Surgery · 87d
Cleared Sep 13, 2002
TITAN MICRO CATHETER, MODEL 105-5074-153
K022003 · DYB
Micro Therapeutics, Inc.
Cardiovascular · 86d
Cleared Sep 13, 2002
CONDUCTIVE GEL
K022006 · GYB
The Dezac Group
Neurology · 86d
Cleared Sep 13, 2002
URETERAL ACCESS SHEATH SET (UASS)
K022135 · KOD
Boston Scientific Corp
Gastroenterology & Urology · 74d
Cleared Sep 13, 2002
NORMED DISTAL RADIUS RECONSTRUCTION SYSTEM
K022231 · HRS
Osteomedics, Inc.
Orthopedic · 65d
Cleared Sep 13, 2002
COATED VICRYL* (POLYGLACTIN 910) SUTURE
K022269 · GAM
Ethicon, Inc.
General & Plastic Surgery · 60d
Cleared Sep 13, 2002
TOTAL BILIRUBIN
K022339 · CIG
Abbott Laboratories
Chemistry · 57d
Cleared Sep 13, 2002
PRESS-MATE PM-2100 VITAL SIGN MONITOR
K022537 · MWI
Colin Medical Instruments Corp.
Cardiovascular · 43d
Cleared Sep 13, 2002
COMFY HIGH RISER WHEELCHAIR
K022617 · IOR
Lenjoy Medical Engineering, Inc.
Physical Medicine · 37d
Cleared Sep 13, 2002
TRANSFER COMPANION HR 3000 MANUAL WHEELCHAIR
K022699 · IOR
Forever Young Ent. Co., Ltd.
Physical Medicine · 31d
Cleared Sep 13, 2002
DELUXE MANUAL WHEELCHAIR HW 4000
K022700 · IOR
Forever Young Ent. Co., Ltd.
Physical Medicine · 31d
Cleared Sep 13, 2002
PTA AND PTV
K022722 · DQY
NuMED, Inc.
Cardiovascular · 28d
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