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
93385–93408 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 21, 1997
CHOICE SUPER SUPPORT PTCA GUIDE WIRE, CHOICE PLUS SUPER SUPPORT PTCA GUIDE...
K964551 · DQX
Scimed Life Systems, Inc.
Cardiovascular · 189d
Cleared May 21, 1997
NICHOLS ADVANTAGE CHEMILUMINESCENCE CALCITONIN KIT
K964635 · JKR
Nichols Institute Diagnostics
Chemistry · 183d
Cleared May 21, 1997
DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYSTEM ALTRATOUCH 1000 DIALYSATE...
K964922 · KDI
Althin Medical AB an Affiliate of...
Gastroenterology & Urology · 163d
Cleared May 21, 1997
VITAL STATISTICS SYSTEM (O-CATH ACCESSORY)
K964978 · DQA
Quinton, Inc.
Anesthesiology · 160d
Cleared May 21, 1997
HYCOR ALLERGEN DISC
K965094 · DHB
Hycor Biomedical, Inc.
Immunology · 153d
Cleared May 21, 1997
ANCA COMBI DIAGNOSTIC TEST KIT
K965133 · MOB
The Binding Site, Ltd.
Immunology · 149d
Cleared May 21, 1997
FIF TM
K970189 · KQJ
Panbio, Inc.
Hematology · 120d
Cleared May 21, 1997
TENOSCOPE
K970642 · HRX
Luxtec Corp.
Orthopedic · 90d
Cleared May 21, 1997
TR NEEDLE
K970871 · KNW
Gallini Intl., Inc.
Gastroenterology & Urology · 72d
Cleared May 21, 1997
PAN (CHIBA ASPIRATING NEEDLE)
K970872 · KNW
Gallini Intl., Inc.
Gastroenterology & Urology · 72d
Cleared May 21, 1997
CEDIA DIGOXIN II
K970883 · KXT
Boehringer Mannheim Corp.
Toxicology · 72d
Cleared May 21, 1997
SYNCHRON CX SYSTEMS URIC ACID (URIC) REAGENT
K970919 · KNK
Beckman Instruments, Inc.
Chemistry · 70d
Cleared May 21, 1997
800 SERIES SURGICAL LASER SYSTEM AND ACCCESSORIES
K970948 · GEX
Laserscope
General & Plastic Surgery · 68d
Cleared May 21, 1997
FREQUENCY 38 (POLYMACON) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND...
K971049 · LPL
Aspect Vision Care, Ltd.
Ophthalmic · 61d
Cleared May 21, 1997
FREQUENCY 55 (METHAFILCON A) HYDROPHILIC CONTACT LENS
K971164 · LPL
Aspect Vision Care, Ltd.
Ophthalmic · 51d
Cleared May 21, 1997
PLAYTEX GENTLE GLIDE NATURAL ODOR ABSORBENT TAMPONS
K971174 · HEB
Playtex, Inc.
Obstetrics & Gynecology · 51d
Cleared May 21, 1997
ACE HDL-C REAGENT
K971526 · LBS
Schiapparelli Biosystems, Inc.
Chemistry · 23d
Cleared May 21, 1997
SYNCHRON SYUSTEMS DAT DRUG FREE URINE CONTROL
K971534 · DIF
Beckman
Toxicology · 23d
Cleared May 20, 1997
SCOPETEX(TM)
K945590 · CCW
Smith Helms Mulliss & Moore, L.L.P.
Anesthesiology · 918d
Cleared May 20, 1997
UROSTYM
K962009 · KPI
Laborie Medical Technologies, Ltd.
Gastroenterology & Urology · 363d
Cleared May 20, 1997
ULTRAFLEX DIAMOND
K962899 · FGE
Boston Scientific Corp
Gastroenterology & Urology · 299d
Cleared May 20, 1997
ZOLL AUTOCLAVABLE INTERNAL HANDLES
K963781 · LDD
Zoll Medical Corp
Cardiovascular · 242d
Cleared May 20, 1997
EUCLID SYSTEMS CORNEAL TOPOGRAPHER MODEL ET800
K964702 · MMQ
Euclid Systems Corp.
Ophthalmic · 176d
Cleared May 20, 1997
2.9F CRAGG-MCNAMARA VALVED INFUSION CATHETER
K964868 · KRA
Micro Therapeutics, Inc.
Cardiovascular · 167d