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
93889–93912 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 22, 1997
NT SERIES ENDODONTIC FILES, MAC SERIES ENDODONTIC FILES
K971319 · EKS
Tycom Dental
Dental · 42d
Cleared May 22, 1997
KIRWAN MODEL 28 1000 BIPOLAR COAGULATOR
K971341 · GEI
Kirwan Surgical Products, Inc.
General & Plastic Surgery · 42d
Cleared May 22, 1997
OSTEONICS ACETABULAR WEDGE SYSTEM
K971422 · MEH
Osteonics Corp.
Orthopedic · 35d
Cleared May 22, 1997
PROSPORE II
K971430 · FRC
Raven Biological Laboratories, Inc.
General Hospital · 35d
Cleared May 22, 1997
AMBUVAC
K971548 · OMP
Kinetic Concepts, Inc.
General & Plastic Surgery · 24d
Cleared May 22, 1997
SIL-TEC SMALL/LARGE BORE TUBING/SIL-TEC HIGH DUROMETER TUBING/SIL-TEC...
K971613 · MIB
Technical Products, Inc.
General & Plastic Surgery · 20d
Cleared May 21, 1997
SYMPHONY NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K963254 · FGE
Boston Scientific Corp
Gastroenterology & Urology · 275d
Cleared May 21, 1997
UNIPOLAR HOOK ELECTRODE (5MM .340MM)/UNIPOLAR HOOK ELECTRODE (5MM. 420MM)
K964329 · GEI
Richard Wolf Medical Instruments Corp.
General & Plastic Surgery · 203d
Cleared May 21, 1997
ROCHE COBAS AMPLICOR ANALYZER
K964506 · JJF
Roche Molecular Systems, Inc.
Chemistry · 194d
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