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
120361–120384 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 30, 1991
ALTA CHANNEL PLATE CONNECTOR
K910482 · HRS
Howmedica Corp.
Orthopedic · 174d
Cleared Jul 30, 1991
PERMANENT IMPLANTABLE FH ENDOCARDIAL LEADS W/TIP
K910608 · DTB
Biotronik, GmbH & Co.
Cardiovascular · 168d
Cleared Jul 30, 1991
507 NON-INVASIVE VITAL SIGNS MONITOR
K910852 · DRT
Criticare Systems, Inc.
Cardiovascular · 153d
Cleared Jul 30, 1991
MODELS 5866-24M/5866-38M/5866-40M/6986M ADAPT KIT
K911302 · DTD
Medtronic Vascular
Cardiovascular · 127d
Cleared Jul 30, 1991
CYTOCLONE A & B EIA
K911958 · LLH
Cambridge Biotech Corp.
Microbiology · 88d
Cleared Jul 30, 1991
GOLD CUP EEG CUTANEOUS ELECTRODE W/LEAD AND EXT.
K911989 · GXY
Somnitec, Inc.
Neurology · 85d
Cleared Jul 30, 1991
MEDI-THERM (MTA-5900) & DETACHABLE HOSES
K912051 · DWJ
Gaymar Industries, Inc.
Cardiovascular · 82d
Cleared Jul 30, 1991
POLY BRAIDED PIGTAIL/PERC CARD CATH W/VAR TIP CONF
K912076 · DQO
The R Group
Cardiovascular · 81d
Cleared Jul 30, 1991
MEDTRONIC CARDIOCARE MEMORYTRACE ER MODEL 4221
K912084 · DXH
Medtronic Vascular
Cardiovascular · 78d
Cleared Jul 30, 1991
CHOLESTECH LIPID MONITORING SYS.
K912136 · CHH
Cholestech Corp.
Chemistry · 77d
Cleared Jul 30, 1991
SOFTOUCH(R) GUIDING CATHETER W/BUMPER TIP
K912191 · DQY
Mallinckrodt Medical
Cardiovascular · 74d
Cleared Jul 30, 1991
PA-393 GOLD BASED/PRECIOUS METAL ALLOYS CLIN USE
K912194 · EJS
Jelenko Co.
Dental · 74d
Cleared Jul 30, 1991
PA-396 GOLD BASED/PRECIOUS METAL ALLOYS CLIN USE
K912195 · EJS
Jelenko Co.
Dental · 74d
Cleared Jul 30, 1991
SOFTTOUCH(R) GUIDING CATHETER
K912199 · DQY
Mallinckrodt Medical
Cardiovascular · 74d
Cleared Jul 30, 1991
STRYKER ECLIPSE WARMING STRETCHER
K912237 · DWI
Stryker Medical
General & Plastic Surgery · 70d
Cleared Jul 30, 1991
DISTAT ANTI-SCL-70 KIT
K912291 · LKJ
Shield Diagnostics, Ltd.
Immunology · 68d
Cleared Jul 30, 1991
DIASTAT ANTI-JO-1 KIT
K912292 · DHN
Shield Diagnostics, Ltd.
Immunology · 68d
Cleared Jul 30, 1991
MEDIKEEPER
K912346 · BRY
Medikeeper, Inc.
Anesthesiology · 63d
Cleared Jul 30, 1991
VITAL-PORT M.R.I. VASCULAR ACCESS SYSTEM 7012,7112
K912423 · LJT
Med Institute, Inc.
General Hospital · 60d
Cleared Jul 30, 1991
VITAL-PORT VASCULAR ACCESS SYSTEM 7010 AND 7110
K912424 · LJT
Med Institute, Inc.
General Hospital · 60d
Cleared Jul 30, 1991
SALTER LABS INFANT NASAL CPAP CANNULA
K912434 · BZD
Salter Labs
Anesthesiology · 57d
Cleared Jul 30, 1991
VITAL-PORT DUAL LUMEN VASCULAR ACCESS SYSTEM 1121
K912465 · LJT
Med Institute, Inc.
General Hospital · 56d
Cleared Jul 30, 1991
IONOSEAL
K912495 · EJK
Voco GmbH
Dental · 55d
Cleared Jul 30, 1991
IONOBOND
K912497 · EMA
Voco GmbH
Dental · 55d