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
115801–115824 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 05, 1992
TECH SIMPLE INFECTIOUS MONONUCLEOSIS SERUM CONTROL
K922726 · KTN
Simplicity Diagnostics, Inc.
Immunology · 122d
Cleared Oct 05, 1992
HSV-1 IGM ELISA TEST -- MODIFICATION
K922758 · LGC
Gull Laboratories, Inc.
Microbiology · 119d
Cleared Oct 05, 1992
HSV-2 IGM ELISA TEST--MODIFICATION
K922759 · LGC
Gull Laboratories, Inc.
Microbiology · 119d
Cleared Oct 05, 1992
KING DIAGNOSTICS CHLORIDE REAGENT
K922921 · CHJ
King Diagnostics, Inc.
Chemistry · 110d
Cleared Oct 05, 1992
CLINCAL HAND MASTER SYSTEM MODEL # EXH9000-002
K922940 · LBB
Exos, Inc.
Neurology · 109d
Cleared Oct 05, 1992
SYSTEM 3000 XENON VIDEOLAP LIGHT
K923210 · GCT
Cabot Medical Corp.
Gastroenterology & Urology · 96d
Cleared Oct 05, 1992
Q-SD
K923255 · GZJ
Quantitative Medicine, Inc.
Neurology · 95d
Cleared Oct 05, 1992
ITC HEARING AID CLUB MODEL LM50
K923292 · ESD
Club Hearing Instruments A/S
Ear, Nose, Throat · 95d
Cleared Oct 05, 1992
SHIMADZU IMAGE AMPLIFIER IA-9LM SERIES
K923453 · JAA
Shimadzu Medical Systems
Radiology · 83d
Cleared Oct 05, 1992
SHIMADZU IMAGE AMPLIFIER IA-9LS SERIES
K923454 · JAA
Shimadzu Medical Systems
Radiology · 83d
Cleared Oct 05, 1992
ORALSAFE
K923469 · EFB
Oralsafe, Inc.
Dental · 83d
Cleared Oct 05, 1992
REUSABLE DUAL DISC BAR RECORDING ELECTRODES
K923665 · JXE
Chalgren Enterprises, Inc.
Neurology · 75d
Cleared Oct 05, 1992
INDOXYL ACETATE DISK
K923700 · JTO
Remel Co.
Microbiology · 73d
Cleared Oct 05, 1992
PULSE RF TEST
K923771 · DHR
Pulse Scientific, Inc.
Immunology · 69d
Cleared Oct 05, 1992
PREMIER BLASTOMYCES
K923859 · MJL
Meridian Diagnostics, Inc.
Microbiology · 66d
Cleared Oct 05, 1992
BATTERY PACK
K923864 · LDD
Portable Power Systems, Inc.
Cardiovascular · 63d
Cleared Oct 05, 1992
MEDIPHONIX CUSTOM FULL SHELL CUSTOM CANAL
K924450 · ESD
Mediphonix, Inc.
Ear, Nose, Throat · 35d
Cleared Oct 02, 1992
COMPUTERIZED PUPIL
K920937 · HLG
Trek Medical Products, Inc.
Ophthalmic · 218d
Cleared Oct 02, 1992
OLYMPUS AMYLASE REAGENT
K923346 · JFJ
Olympus Corp.
Chemistry · 94d
Cleared Oct 02, 1992
RADIFOCUS GUIDE WIRE M
K923607 · KOD
Terumo Medical Corp.
Gastroenterology & Urology · 78d
Cleared Oct 02, 1992
OLYMPUS TOTAL BILIRUBIN REAGENT
K923609 · CIG
Olympus Corp.
Chemistry · 79d
Cleared Oct 02, 1992
OLYMPUS CHLORIDE REAGENT
K923610 · CHJ
Olympus Corp.
Chemistry · 81d
Cleared Oct 01, 1992
CRF CHARCOAL CANISTER REPLACEMENT FILTER
K920209 · FYD
Quinn Healthcare Products
General Hospital · 259d
Cleared Oct 01, 1992
SRH-678 VACCUUM TUBING
K920210 · FYD
Quinn Healthcare Products
General Hospital · 259d