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
116905–116928 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 16, 1992
VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM
K921746 · CGJ
Biomerieux Vitek, Inc.
Chemistry · 64d
Cleared Jun 16, 1992
RENAMEL ESTHETIC RESTORATIVE SYSTEM, MODIFICATION
K921820 · EBF
Cosmedent, Inc.
Dental · 63d
Cleared Jun 16, 1992
SHIMADZU IMAGE AMPLIFIER IA-12VSA SERIES
K922012 · JAA
Shimadzu Medical Systems
Radiology · 48d
Cleared Jun 16, 1992
ROCHE CALIBRATOR SERUM
K922043 · JIX
Roche Diagnostic Systems, Inc.
Chemistry · 46d
Cleared Jun 16, 1992
ROTOLUX, SELECTOLUX, SHUTTERVUE
K922079 · IXC
American Medical Sales, Inc.
Radiology · 43d
Cleared Jun 16, 1992
SHOWERFLOSS ORAL IRRIGATION UNIT
K922307 · EFS
Showerfloss, Inc.
Dental · 32d
Cleared Jun 16, 1992
BITE RIM WAX
K922380 · EGD
Dentsply Intl.
Dental · 27d
Cleared Jun 15, 1992
ND
K915578 · GEX
Heraeus Lasersonics, Inc.
General & Plastic Surgery · 185d
Cleared Jun 15, 1992
LPI ML 100/532 AND ML 532 SURGICAL LASER
K915631 · GEX
Laser Photonics, Inc.
General & Plastic Surgery · 181d
Cleared Jun 15, 1992
VIVUS 50 AND VIVUS 100 PERSONAL INFUSER
K915646 · FRN
I-Flow Corp.
General Hospital · 180d
Cleared Jun 15, 1992
OMNIMED HOLMIUM LASER AND DELIVERY SYSTEM
K915651 · GEX
Summit Technology, Inc.
General & Plastic Surgery · 180d
Cleared Jun 15, 1992
TECH DYNE - HP-2000, SKREEN TEST, RMS-200
K920183 · LBB
Tech Dyne Group
Neurology · 152d
Cleared Jun 15, 1992
PATIENT EXAMINATION GLOVES
K921376 · LYY
Seal Polymer Industries Bhd.
General Hospital · 87d
Cleared Jun 15, 1992
VISTA HP/HPQ SYSTEM
K921609 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 73d
Cleared Jun 15, 1992
AUTOMATES COMA COCAINE METABOLITE ASSAY
K921834 · DIO
Serex, Inc.
Toxicology · 60d
Cleared Jun 12, 1992
TROCAR SHEATH ANCHOR
K915116 · HET
Origin Medsystems, Inc.
Obstetrics & Gynecology · 212d
Cleared Jun 12, 1992
CUSA SYSTEM 200C AND 200T ULTRASONIC ASPIRATOR
K921251 · LFL
Valleylab, Inc.
General & Plastic Surgery · 88d
Cleared Jun 11, 1992
INFRASONICS VENTILATOR ADULT STAR, MODIFICATION
K911804 · CBK
Infrasonics Corp.
Anesthesiology · 414d
Cleared Jun 11, 1992
MICRO-COLL COLLAGEN WOUND SPRAY
K912565 · SEJ
Micro-Coll
General & Plastic Surgery · 366d
Cleared Jun 11, 1992
BEAR 7 VENTILATOR
K912619 · CBK
Bear Medical Systems, Inc.
Anesthesiology · 364d
Cleared Jun 11, 1992
MENTOR ODYSSEY PHACOEMULSIFICATION SYSTEM
K912904 · HQC
Mentor O & O, Inc.
Ophthalmic · 345d
Cleared Jun 11, 1992
MONOCRYSTANT PH-REFERENCE CATHETER, MODIFICATION
K913817 · FFT
Synectics-Dantec
Gastroenterology & Urology · 290d
Cleared Jun 11, 1992
GRIESHABER SNARE INSTRUMENT AND SNARE CARTRIDGE
K914588 · GAW
Grieshaber & Co.
General & Plastic Surgery · 239d
Cleared Jun 11, 1992
AUTO SUTURE(R) ARTICULATING ENDOSCOPIC SCISSORS
K914752 · GCJ
United States Surgical, A Division of...
General & Plastic Surgery · 233d