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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
140473–140496 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 11, 1987
SPACELABS MODEL 90419 PULSE OXIMETER MODULE
K864279 · DQA
Spacelabs, Inc.
Anesthesiology · 132d
Cleared Mar 11, 1987
PONTALLOR 4 DENTAL ALLOY
K870024 · EJT
Degussa Dental, Inc.
Dental · 65d
Cleared Mar 11, 1987
TORQUEDRIVER WRENCH
K870053 · HXC
Jerome Medical
Orthopedic · 63d
Cleared Mar 11, 1987
MODEL MS-II MINISTIM
K870338 · BXN
Life-Tech Intl., Inc.
Anesthesiology · 42d
Cleared Mar 11, 1987
ESCORT EC CUSTOM IN-THE-EAR HEARING AID
K870350 · ESD
Hearing Tech, Inc.
Ear, Nose, Throat · 41d
Cleared Mar 11, 1987
MODEL 78534C MONITOR/TERMINAL W/OPTIONS A03
K870380 · DPS
Hewlett-Packard Co.
Cardiovascular · 41d
Cleared Mar 11, 1987
MODEL 350 WIRELESS BICROS/MULTICROS HEARING AIDS
K870434 · ESD
Telex Communications, Inc.
Ear, Nose, Throat · 36d
Cleared Mar 11, 1987
MODEL 350 WIRELESS CROS/CROS LOW OUTPUT HEAR. AID
K870435 · ESD
Telex Communications, Inc.
Ear, Nose, Throat · 36d
Cleared Mar 11, 1987
HEARING AID, UNITRON MODEL UM60
K870503 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 35d
Cleared Mar 11, 1987
WARSAW ORTHOPEDIC POINTED REAMER
K870845 · HTO
Warsaw Orthopedic, Inc.
Orthopedic · 8d
Cleared Mar 10, 1987
CARDIOMAX-II
K861543 · DXG
Columbus Instruments Intl. Corp.
Cardiovascular · 320d
Cleared Mar 10, 1987
DIMENSION-WBG
K863223 · CGA
Dimension Diagnostics
Chemistry · 201d
Cleared Mar 10, 1987
OCEAN SCIENTIFIC VDRL TEST
K864731 · GMQ
Ocean Scientific, Inc.
Microbiology · 96d
Cleared Mar 10, 1987
DIASONICS SPA 5.O 27MM PROBE
K864758 · ITX
Diasonics, Inc.
Radiology · 95d
Cleared Mar 10, 1987
DIASONICS SPA 3.5 MHZ, 30MM PROBE
K864812 · ITX
Diasonics, Inc.
Radiology · 91d
Cleared Mar 10, 1987
LIFESOUND(TM) ESOPHAGEAL STETHOSCOPE W/THERMISTOR
K864858 · BZT
Biomedical Concepts, Inc.
Anesthesiology · 89d
Cleared Mar 10, 1987
SEGURA DRETLER BASKET
K864874 · FFL
Van-Tec, Inc.
Gastroenterology & Urology · 88d
Cleared Mar 10, 1987
BICARBONATE MIXING SYSTEM
K864942 · KPO
Morris Tool , Ltd.
Gastroenterology & Urology · 83d
Cleared Mar 10, 1987
TERUMO DENTAL NEEDLES
K864970 · DZM
Terumo Medical Corp.
Dental · 78d
Cleared Mar 10, 1987
DISPOS GEL EXTERNAL PACING ELECTRODE/LOW IMPEDANCE
K864985 · DRO
Medac, Inc.
Cardiovascular · 78d
Cleared Mar 10, 1987
CARDIOFAX-V ECG-8240A
K865030 · DSI
Nihon Kohden America, Inc.
Cardiovascular · 77d
Cleared Mar 10, 1987
CARDIOFAX-V ECG-834OA
K865032 · DSI
Nihon Kohden America, Inc.
Cardiovascular · 77d
Cleared Mar 10, 1987
TANDEMR ICONR II HCG(SERUM) IMMUNOENZYMETRIC ASSAY
K865057 · JHI
Hybritech, Inc.
Chemistry · 76d
Cleared Mar 10, 1987
WILLIAMS FLEXIBLE CYSTOSCOPIC INJECTION NEEDLE
K865086 · FBK
Van-Tec, Inc.
Gastroenterology & Urology · 70d