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
122593–122616 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 15, 1991
ISOLA(TM) SPINE SYSTEM TOP ENTRY HOOK
K905184 · KWP
Acromed Corp.
Orthopedic · 88d
Cleared Feb 15, 1991
GERI TOTAL HIP SYSTEM
K905186 · LWJ
Smith & Nephew Richards, Inc.
Orthopedic · 88d
Cleared Feb 15, 1991
PERIO PIK
K905188 · EFS
Teledyne Water Pik
Dental · 88d
Cleared Feb 15, 1991
OCHSNER 50 VASCULAR PROSTHESIS
K905270 · DSY
Intervascular, Inc.
Cardiovascular · 84d
Cleared Feb 15, 1991
ULTRACISION HARMONIC SCALPEL
K905315 · GEI
Ultracision, Inc.
General & Plastic Surgery · 79d
Cleared Feb 15, 1991
CONDOMS
K905854 · HIS
Barnetts, Inc.
Obstetrics & Gynecology · 59d
Cleared Feb 14, 1991
MEDTRONIC (R) MODEL 3625 SCREENER
K903690 · GZB
Medtronic Vascular
Neurology · 183d
Cleared Feb 14, 1991
FIBRINOTEST(TM) - FIBRINOGEN ASSAY
K903874 · GIS
Haemachem, Inc.
Hematology · 176d
Cleared Feb 14, 1991
EYE SEE INSTRUMENT
K905237 · HPN
King Tool, Inc.
Ophthalmic · 90d
Cleared Feb 14, 1991
CYBEX 6000
K905525 · IKK
Cybex
Physical Medicine · 66d
Cleared Feb 14, 1991
MYOCARDIAL TEMPERATURE MONITORING PROBES, CJ-1000
K905652 · FLL
Daily Medical Products, Inc.
General Hospital · 58d
Cleared Feb 14, 1991
TENONE(TM) METHAMPHETAMINE
K910043 · LAF
Diagnostic Products Corp.
Toxicology · 41d
Cleared Feb 14, 1991
DATA RECORDER
K910118 · FLL
Healthdyne, Inc.
General Hospital · 34d
Cleared Feb 14, 1991
TRAVELER, MOTORIZED THREE-WHEELED VEHICLE
K910265 · INI
Pillar Technology, Inc.
Physical Medicine · 27d
Cleared Feb 14, 1991
IMS DISPOSABLE HOLDER WITH NEEDLE RETRACTOR
K910455 · FMI
Ziehm International, Inc.
General Hospital · 13d
Cleared Feb 13, 1991
7.5 MHZ BI PLANE RECTAL PROBE (P/N: 041-815)
K902728 · ITX
Ausonics Pty , Ltd.
Radiology · 237d
Cleared Feb 13, 1991
G.E. DXD 325/350/350II/DXD 525/525II GENERATORS
K902986 · IZO
Electromek Diagnostic Systems, Inc.
Radiology · 232d
Cleared Feb 13, 1991
PRIMARY MANUFACTURER SUNGLASSES
K903065 · HQY
Mao Lin Ent.
Ophthalmic · 219d
Cleared Feb 13, 1991
AVALON GENERAL PURPOSE SCANNER, PREVIEW GP
K904317 · DPW
Avalon Technology Corp.
Cardiovascular · 146d
Cleared Feb 13, 1991
WHITESIDE ORTHOLOC MODULAR TIBIAL CONSTRAIN.INSERT
K905076 · JWH
Dow Corning Wright
Orthopedic · 92d
Cleared Feb 13, 1991
HIGH SPEED CEREAMIC BEARING TURBINE HANDPIECES
K905155 · EFB
Star Dental Mfg. Co.
Dental · 90d
Cleared Feb 13, 1991
TUBE DECLOGGER
K905164 · KNT
Nova Design Technologies, Ltd.
Gastroenterology & Urology · 89d
Cleared Feb 13, 1991
OLYMPUS URINE PH CALIBRATORS LEVELS I AND II
K905477 · JIS
Em Diagnostic Systems, Inc.
Chemistry · 69d
Cleared Feb 13, 1991
CREATININE (RATE) REAGENT SET
K905619 · CGX
Biochemical Trade, Inc.
Chemistry · 61d