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
89881–89904 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 23, 1998
MULTI-PARAMETER MODULE (M3000A)/DISPLAY UNIT (M3046A)
K971910 · DSI
Hewlett-Packard GmbH
Cardiovascular · 304d
Cleared Mar 23, 1998
HURRISEAL DENTIN DESENSITIZER
K973002 · KLE
Cheng & Assoc., Inc.
Dental · 223d
Cleared Mar 23, 1998
MERCURY DENTAL
K973548 · ELY
Aleaciones Dentales Zeyco, S.A. DE C.V.
Dental · 186d
Cleared Mar 23, 1998
ROUND WINDOW E-CATH
K973740 · ETD
Neuro-Biometrix, Inc.
Ear, Nose, Throat · 173d
Cleared Mar 23, 1998
THE TCS-MEDCON'S TELECARDIOLOGY SYSTEM
K974679 · IZI
Medcon , Ltd.
Radiology · 98d
Cleared Mar 23, 1998
VYGON NEO-SUMP
K974806 · KNT
Vygon Corp.
Gastroenterology & Urology · 90d
Cleared Mar 23, 1998
SELECTCELLS(TM) MINI
K974819 · HHK
Select Medical Systems, Inc.
Obstetrics & Gynecology · 90d
Cleared Mar 23, 1998
METHAFILCON A SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
K980218 · LPL
Biocompatibles Eyewear, Inc.
Ophthalmic · 66d
Cleared Mar 23, 1998
STORZ MILLENNIUM MICROSURGICL SYSTEM HIGH SPEED VITRECTOMY SYSTEM
K980488 · HQE
Storz Instrument Co.
Ophthalmic · 42d
Cleared Mar 23, 1998
ERO-SCAN OTOACOUSTIC EMISSIONS TEST INST. (ER34)
K980533 · EWO
Etymotic Research
Ear, Nose, Throat · 40d
Cleared Mar 23, 1998
SOLOBOND M
K980539 · KLE
Voco GmbH
Dental · 39d
Cleared Mar 23, 1998
TRIMAX RADIOGRAPHIC CASSETTE
K980722 · IXA
Imation Corp.
Radiology · 27d
Cleared Mar 20, 1998
TOWNLEY PEDICLE SCREW PLATING SYSTEM
K970599 · MNI
Danek Medical, Inc.
Orthopedic · 395d
Cleared Mar 20, 1998
MICRO-STRIP FOR AMPHETAMINE METABOLITES
K974611 · DKZ
Microdiagnostics, Inc.
Toxicology · 99d
Cleared Mar 20, 1998
CRE(TM) BALLOON DILATATION CATHETER
K974788 · KNQ
Boston Scientific Corp
Gastroenterology & Urology · 88d
Cleared Mar 20, 1998
STERICHEK(TM) RESIDUAL PEROXIDE REAGENT STRPS
K974798 · LIF
Environmental Test Systems, Inc.
Gastroenterology & Urology · 88d
Cleared Mar 20, 1998
BIONX DISTAL RADIUS SCREW
K974876 · MAI
Bionx Implants, Inc.
Orthopedic · 81d
Cleared Mar 20, 1998
TRIAGE C. DIFFICILE, TRIAGE C. DIFFICILE PANEL, TRIAGE C. DIFFICILE TOXIN A
K974881 · MCB
Biosite Incorporated
Microbiology · 80d
Cleared Mar 20, 1998
MONOJECTT BLUNTIP I.V. ACCESS CANNULA WITH VIAL ACCESS PIN DEVICE
K980062 · FMI
Davis & Geck, Inc.
General Hospital · 72d
Cleared Mar 20, 1998
ACS HI-TORQUE WHOLEY SUPRA CORE GUIDE WIRE
K980119 · DQX
Guidant Corp.
Cardiovascular · 66d
Cleared Mar 20, 1998
INFINITY AST REAGENT (PROCEDURE NO. 51)
K980666 · CIT
Sigma Diagnostics, Inc.
Chemistry · 28d
Cleared Mar 20, 1998
RAPID DRUG SCREEN' 8 PANEL
K980872 · DIO
American Bio Medica Corp.
Toxicology · 14d
Cleared Mar 19, 1998
TUMORLOCALIZER MRI
K962615 · MIG
Ferguson Medical
Toxicology · 624d
Cleared Mar 19, 1998
PUNCTURENEEDLE
K963794 · KNW
Ferguson Medical
Gastroenterology & Urology · 545d