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
119113–119136 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 08, 1991
THE BIG EASY Y-ADAPTER
K914046 · DYB
Microvena Corp.
Cardiovascular · 59d
Cleared Nov 08, 1991
RONDEX CPR NON REBREATHING VALVE #9030, MODIFIED
K914195 · CBP
Rondex Products, Inc.
Anesthesiology · 64d
Cleared Nov 08, 1991
RONDEX MASKS MODELS 9015/9011/901102 MODIFIED
K914196 · BTM
Rondex Products, Inc.
Anesthesiology · 64d
Cleared Nov 08, 1991
MODEL DLASE 500 ND:YAG LASE SYS:INTRA SFT TIS SURG
K914677 · GEX
Sunrise Technologies, Inc.
General & Plastic Surgery · 21d
Cleared Nov 07, 1991
THERMA-H
K905276 · LKX
Kure Swiss Medical AG Corp.
Gastroenterology & Urology · 349d
Cleared Nov 07, 1991
INDIRECT FLUORESCENT ASSAY FOR HERPES SIMPLEX 1
K905608 · GQL
Stellar Bio Systems, Inc.
Microbiology · 328d
Cleared Nov 07, 1991
BAXA PCA INFUSOR
K910257 · MEA
Baxa Corp., Sub. of Cook Group, Inc.
General Hospital · 289d
Cleared Nov 07, 1991
ACCU-BEAM LAPAROSCOPIC SYSTEM
K910978 · GEI
Tti Medical
General & Plastic Surgery · 245d
Cleared Nov 07, 1991
TEARTEC RAPID LACRIMAL ASSESMENT SYSTEM
K911734 · KYD
Northland Cataract & Eye Care Clinic
Ophthalmic · 204d
Cleared Nov 07, 1991
CARDIODYNE KINETORR/PC BLOOD PRESSURE MONITORS
K911871 · DXN
Cardiodyne, Inc.
Cardiovascular · 195d
Cleared Nov 07, 1991
POLARIS, OPHTHALMOLOGY
K911926 · GEX
Pfizer Laser Systems
General & Plastic Surgery · 195d
Cleared Nov 07, 1991
TRANSESOPHAGEAL TRANSDUCER THERMAL SAFETY
K912404 · DPT
Hewlett-Packard Co.
Radiology · 161d
Cleared Nov 07, 1991
ROCKET SURGICAL SKIN MARKING PEN
K912730 · FZZ
West Texas Lighthouse For the Blind
General & Plastic Surgery · 140d
Cleared Nov 07, 1991
VARIAN C-SERIES CLINACS (CLINAC 2300C/D)
K913119 · IYE
Varian Assoc., Inc.
Radiology · 115d
Cleared Nov 07, 1991
HUMAN BETA-2 MICROGLOBIN EN-RID KIT
K913131 · JZG
The Binding Site, Ltd.
Immunology · 114d
Cleared Nov 07, 1991
DELPHIN II CENTRIFUGAL SYSTEM
K913176 · KFM
3M Health Care, Sarns
Cardiovascular · 113d
Cleared Nov 07, 1991
ONE TOUCH(R) II HOSPITAL BLOOD GLUCOSE MONIT SYST
K913357 · CGA
Lifescan, Inc.
Chemistry · 101d
Cleared Nov 07, 1991
MODEL M1403A TELEMETRY MONITORING SYSTEMS (TMS)
K913533 · DXH
Hewlett-Packard Co.
Cardiovascular · 90d
Cleared Nov 07, 1991
RELIABLE CONE STYLE FACE MASK
K913558 · FXX
Anago, Inc.
General Hospital · 90d
Cleared Nov 07, 1991
OSTEO COMPLETE PNEUMATIC DRILL-OSCILAIR
K913559 · HSZ
Osteo AG
Orthopedic · 90d
Cleared Nov 07, 1991
SAFETY PLUS DENTAL INJECTION NEEDLE
K913573 · DZM
Specialites Septodont
Dental · 87d
Cleared Nov 07, 1991
LSF DIAGNOSTIC RELATED GROUP CEMENTED HIP
K913616 · JDI
Implant Technology, Inc.
Orthopedic · 86d
Cleared Nov 07, 1991
3M ANTI-DSDNA FAST TEST
K913653 · LRM
3M Diagnostic Systems, Inc.
Immunology · 83d
Cleared Nov 07, 1991
UNICATH EP.
K913685 · IZI
Xre Corp.
Radiology · 80d