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
87409–87432 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 15, 1999
BLUE SENSOR SUPATAB,DISPOSABLE ECG ELECTRODES
K983689 · DRX
Medicotest A/S
Cardiovascular · 87d
Cleared Jan 15, 1999
WAKO L-TYPE FE, WAKO L-TYPE CALIBRATOR
K984119 · CFM
Wako Chemicals USA, Inc.
Chemistry · 58d
Cleared Jan 14, 1999
ROTECNO FR (FLUID RESISTANT) SURGICAL GOWN
K982058 · FYA
Encompass Group, LLC
General Hospital · 217d
Cleared Jan 14, 1999
FM DEMODULATOR-4 LEAD MODEL #8500-05 AND FM DEMODULATOR-12 LEAD MODEL # 8500-25
K982228 · DXH
Tz Medical, Inc.
Cardiovascular · 203d
Cleared Jan 14, 1999
VISIONS 8.2F PV ULTRASONIC IMAGING CATHETER (MODEL 88900)
K982329 · ITX
Endosonics Corp.
Radiology · 196d
Cleared Jan 14, 1999
AIRZONE PEAK FLOWMETER
K982334 · BZH
Clement Clarke Intl., Ltd.
Anesthesiology · 196d
Cleared Jan 14, 1999
AQUA PURATOR-BIOTHERM, WISAP MODEL # 1608
K982518 · HET
Wisap Gesellschaft Fur Wissenschaftl....
Obstetrics & Gynecology · 178d
Cleared Jan 14, 1999
MEDWORKS VISUALIZATION INSEMINATION CATHETER
K982630 · MFD
Medworks Corp.
Obstetrics & Gynecology · 170d
Cleared Jan 14, 1999
INTROCAN SAFETY IV CATHETER
K982805 · FOZ
B.Braun Medical, Inc.
General Hospital · 157d
Cleared Jan 14, 1999
DENTAL STERLIZATION TRAY/CASSETTE
K983223 · FRG
Brasseler USA I, L.P.
General Hospital · 122d
Cleared Jan 14, 1999
GLOVE SEAL D'PRO LATEX EXAMINATION GLOVE
K983570 · LYY
Glove Seal Sdn Bhd
General Hospital · 93d
Cleared Jan 14, 1999
STEALTHSTATION SYSTEM
K983670 · HAW
Surgical Navigation Technologies, Inc.
Neurology · 87d
Cleared Jan 14, 1999
UNIK TONGUE CLEANER
K983683 · LCN
Unik Products, Inc.
Dental · 86d
Cleared Jan 14, 1999
GOTFRIED PERCUTANEOUS COMPRESSION PLATING SYSTEM
K983814 · JDO
Efratgo, Ltd. HI Tech Bio-Surgical
Orthopedic · 78d
Cleared Jan 14, 1999
PACSCACHE
K983815 · LLZ
Dome Imaging Systems, Inc.
Radiology · 78d
Cleared Jan 14, 1999
MAXIKLEEN-LATEX EXAMINATION GLOVE POWDER FREE
K983827 · LYY
Sinetimed Latex Sdn Bhd
General Hospital · 76d
Cleared Jan 14, 1999
HYS-SURGIFLATOR 150P
K983889 · HIG
W.O.M. World of Medicine GmbH
Obstetrics & Gynecology · 73d
Cleared Jan 14, 1999
VINYL EXAMINATION GLOVES, PREPOWDERED USP
K984094 · LYZ
Trans Ancient Products Co., Ltd.
General Hospital · 59d
Cleared Jan 14, 1999
MODIFICATION OF PURESPERM
K984172 · MQL
Nidacon International AB
Obstetrics & Gynecology · 55d
Cleared Jan 14, 1999
AZTECH 70
K984524 · EHD
Villa Sistemi Medicali S.P.A.
Radiology · 24d
Cleared Jan 14, 1999
GLOBAL FX HUMERAL STEM, GLOBAL ADVANTAGE HUMERAL HEAD
K984541 · KWT
DePuy Orthopaedics, Inc.
Orthopedic · 24d
Cleared Jan 14, 1999
TALKING DIGITAL THERMOMETER, MODEL KV-171
K984553 · FLL
K-Jump Health Co., Ltd.
General Hospital · 23d
Cleared Jan 14, 1999
MULTI-PURPOSE DISINFECTING SOLUTION ID 90746
K984575 · LPN
Alcon Laboratories
Ophthalmic · 22d
Cleared Jan 13, 1999
CRYO CHECK FACTOR XI DEFICIENT PLASMA, MODEL FDP11-10 (1.OML) AND FDP11-15...
K981173 · GJT
Precision Biologicals, Inc.
Hematology · 287d