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
79009–79032 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 13, 2001
HYDRAGEL ISO-PAL K20 (PN 3022)
K011113 · CIN
Sebia
Chemistry · 63d
Cleared Jun 13, 2001
NASAL CANNULA, WITH AND WITHOUT SUPPLY TUBING, AND OTHER SIMILAR NASAL...
K011125 · CAT
Hudson Respiratory Care, Inc.
Anesthesiology · 61d
Cleared Jun 13, 2001
OXYGEN SUPPLY TUBING, MODEL 1115
K011134 · BYX
Hudson Respiratory Care, Inc.
Anesthesiology · 61d
Cleared Jun 13, 2001
ULTRACONCENTRATOR SYSTEM
K011148 · FJI
Interpore Cross Intl.
Gastroenterology & Urology · 58d
Cleared Jun 13, 2001
CHLORINATED POWDERED LATEX EXAMINATION GLOVES, BLUE, GREEN
K011231 · LYY
Protection Gloves Sdn. Bhd.
General Hospital · 51d
Cleared Jun 13, 2001
BIOCURVE SOFT (HIOXIFILCON B) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY...
K011234 · LPL
American Biocurve, Inc.
Ophthalmic · 51d
Cleared Jun 13, 2001
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLS
K011250 · JJX
Ortho-Clinical Diagnostics, Inc.
Microbiology · 50d
Cleared Jun 13, 2001
BIOCURVE SOFT (HIOXIFILCOM A) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY...
K011316 · LPL
American Contact Lens, Inc.
Ophthalmic · 44d
Cleared Jun 13, 2001
HARDYDISK NOVOBIOCIN, 30MCG, MODEL Z883
K011384 · JTN
Hardy Diagnostics
Microbiology · 37d
Cleared Jun 13, 2001
SELF-ADHESIVE ELECTRODES
K011411 · GXY
Pain Management Technologies
Neurology · 36d
Cleared Jun 13, 2001
SILICONE IMPRESSION MATERIAL
K011450 · ELW
Northeast Resins & Silicones, LLC
Dental · 33d
Cleared Jun 13, 2001
OIL FOR TISSUE CULTURE
K011462 · MQL
Conception Technologies
Obstetrics & Gynecology · 30d
Cleared Jun 13, 2001
VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE RANGE VERIFIERS
K011463 · JJX
Ortho-Clinical Diagnostics
Chemistry · 30d
Cleared Jun 13, 2001
RX VIATRAC 14 PERIPHERAL DILATATION CATHETER, OTW VIATRAC 18 PERIPHERAL...
K011464 · DQY
Vascular Intervention
Cardiovascular · 30d
Cleared Jun 13, 2001
BARRETT UNICONDYLAR TIBIAL BEARING
K011509 · HRY
Biomet, Inc.
Orthopedic · 28d
Cleared Jun 13, 2001
FAST THERMOMETER MODELS ST713C AND ST713F
K011585 · FLL
Mesure Technology
General Hospital · 21d
Cleared Jun 13, 2001
WATER FOR ASSISTED REPRODUCTIVE TECHNOLOGIES (A.R.T.) USE
K011598 · MTW
Irvine Scientific Sales Co., Inc.
Obstetrics & Gynecology · 20d
Cleared Jun 13, 2001
TRUMPF SURGICAL LIGHTS, MODELS 301,501,701,1001
K011693 · FSY
Trumpf Medical Systems, Inc.
General & Plastic Surgery · 13d
Cleared Jun 13, 2001
WORLAND UNICONDYLAR TIBIAL BEARING
K011795 · HRY
Biomet, Inc.
Orthopedic · 5d
Cleared Jun 12, 2001
GERATHERM BABYWATCH TEMPERATURE MONITOR
K001281 · FLL
Geratherm AG
General Hospital · 417d
Cleared Jun 12, 2001
MULTI-STIM, MODEL MS-100
K001897 · GZJ
Metron Medical Australia, Pty, Ltd.
Neurology · 356d
Cleared Jun 12, 2001
AMBULATORY ENTERAL NUTRITION PUMP
K003047 · LZH
Ross Product Div. Abbott Laboratories
General Hospital · 256d
Cleared Jun 12, 2001
MEDCOMP ULTRA-FLOW CATHETER
K003207 · MSD
Medical Components, Inc.
Gastroenterology & Urology · 242d
Cleared Jun 12, 2001
CD HORIZON SPINAL SYSTEM, 4.5 ROD FOR POSTERIOR APPLICATION
K010181 · KWP
Medtronic Sofamor Danek, Inc.
Orthopedic · 144d