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
84649–84672 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 27, 1999
TEMP TELLER - DIGITAL THERMOMETER, MODELS DT-101, DT-102, DT-103, DT-201,...
K992601 · FLL
Oriental System Technology, Inc.
General Hospital · 85d
Cleared Oct 27, 1999
SDB CERCLAGE SYSTEM
K992616 · JDQ
Pioneer Surgical Technology
Orthopedic · 84d
Cleared Oct 27, 1999
HEX BUTTON
K992617 · HTN
Pioneer Surgical Technology
Orthopedic · 84d
Cleared Oct 27, 1999
MODEL IRC 1001 AEROSOL COMPRESSOR
K992643 · CAF
Invacare Corp.
Anesthesiology · 82d
Cleared Oct 27, 1999
SHELLY PROTECTED AV FISTULA NEEDLE
K992653 · FIE
Diasol, Inc.
Gastroenterology & Urology · 82d
Cleared Oct 27, 1999
ZMR HIP SYSTEM-REVISION TAPER
K992667 · LPH
Zimmer, Inc.
Orthopedic · 79d
Cleared Oct 27, 1999
NEXT GENERATION RODDING SYSTEM
K992784 · KWQ
United States Surgical, A Division of...
Orthopedic · 69d
Cleared Oct 27, 1999
SAFESKIN POLYMER-COATED NITRILE EXAMINATION GLOVES, POWDER-FREE SHIELDMASTER...
K992830 · LZA
Safeskin Corp.
General Hospital · 65d
Cleared Oct 27, 1999
BARIATRIC LAPAROSCOPE, MODEL 367
K993045 · GCJ
Stryker Endoscopy
General & Plastic Surgery · 47d
Cleared Oct 27, 1999
HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED LATEX EXAMINATINO GLOVES, WITH...
K993097 · LYY
Pamitex Industries Sdn Bhd
General Hospital · 41d
Cleared Oct 27, 1999
ILLUSION
K993192 · EBF
Bisco, Inc.
Dental · 64d
Cleared Oct 27, 1999
SENSI-PRO DISPOSABLE POWDERED VINYL SYNTHETIC EXAMINATION GLOVES WITH WHITE...
K993231 · LYZ
Shinemound Enterprise, Inc.
General Hospital · 30d
Cleared Oct 27, 1999
SENSI-PRO DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES WITH...
K993240 · LYZ
Shinemound Enterprise, Inc.
General Hospital · 30d
Cleared Oct 27, 1999
SUPERGLOVES, POWDER FREE NITRILE EXAMINATION GLOVES
K993258 · LZA
Supermax Sdn Bhd
General Hospital · 28d
Cleared Oct 27, 1999
IQ NASAL MASK, MODEL P/N 50160
K993269 · BZD
Sleepnet Corporation
Anesthesiology · 27d
Cleared Oct 27, 1999
ARIA LX CPAP SYSTEM
K993307 · BZD
Respironics, Inc.
Anesthesiology · 23d
Cleared Oct 27, 1999
ROTORBLADE SUTURE ANCHOR
K993373 · MAI
Li Medical Technologies, Inc.
Orthopedic · 20d
Cleared Oct 27, 1999
VIRTUOSO LX SMART CPAP SYSTEM
K993433 · BZD
Respironics, Inc.
Anesthesiology · 15d
Cleared Oct 26, 1999
SKINTACT ECG ELECTRODES, S&W ECG ELECTRODES
K982521 · DRX
Leonhard Lang Co.
Cardiovascular · 463d
Cleared Oct 26, 1999
ENDOREZ
K992097 · KIF
Ultradent Products, Inc.
Dental · 127d
Cleared Oct 26, 1999
SPECTRUM DESIGNS SPECTRAGEL
K992522 · MDA
Spectrum Designs, Inc.
General & Plastic Surgery · 90d
Cleared Oct 26, 1999
TRANSVAGINAL HYDRO LAPAROSCOPY (THL) SYSTEM
K992544 · HEX
Circon Corp.
Obstetrics & Gynecology · 88d
Cleared Oct 26, 1999
GINRAM ENDOCIC SINGLE OVAL PORT (MODEL NO. 720195)
K992926 · HHK
Ri Mos. S.R.L.
Obstetrics & Gynecology · 56d
Cleared Oct 26, 1999
GOLD CORE 55
K993173 · EJT
Jeneric/Pentron, Inc.
Dental · 34d