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
122329–122352 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 08, 1991
SYSNPAR PORCELAIN
K910303 · ELL
Jeneric/Pentron, Inc.
Dental · 43d
Cleared Mar 08, 1991
EVIDENCE BIOLOGICAL INDICATOR
K910417 · FRC
Skyland Scientific Services, Inc.
General Hospital · 37d
Cleared Mar 08, 1991
MEDID-VAC CLEAR NONCONDUCTIVE CONNECTING TUBE
K910471 · GAZ
Baxter Healthcare Corp
General Hospital · 32d
Cleared Mar 07, 1991
JOSLYN EO STERILIZER/ EO MODERNIZATION KIT
K901146 · FLF
Joslyn Valve Corp.
General Hospital · 360d
Cleared Mar 07, 1991
STEREOTACTIC ONE MEDICAL APPLICATION SOFTWARE
K901883 · HAW
Stereotactic Image Systems, Inc.
Neurology · 315d
Cleared Mar 07, 1991
BSM/21&22 SC BLOOD SAFE MOD & V.P.M. VEN PRESS MOD
K902588 · KOC
Gambro-Hospal, Inc.
Gastroenterology & Urology · 268d
Cleared Mar 07, 1991
VYGON LIFEVAC PICC
K903648 · LJS
Vygon Corp.
General Hospital · 206d
Cleared Mar 07, 1991
SENSI RADS LEAD LATEX RADIATION PROT. GLOVE, STER.
K904878 · IWP
Hpi, Inc.
Radiology · 128d
Cleared Mar 07, 1991
BODY COMPOSITION ANALYZER
K904970 · DSB
Body Composition Analog, Inc.
Cardiovascular · 122d
Cleared Mar 07, 1991
ANTERIOR NECK CONTOUR COIL
K905512 · LNH
Magnetic Research, Inc.
Radiology · 87d
Cleared Mar 07, 1991
LARES 757 WORKHORSE HIGHSPEED HANDPIECE
K905541 · EFB
Lares Research, Inc.
Dental · 86d
Cleared Mar 07, 1991
COMPRINET, COMTESSE AND BELLAVAR STOCKINGS
K905631 · DWL
Jobst Institute, Inc.
General Hospital · 80d
Cleared Mar 07, 1991
ZIMMER CERAMIC FEMORAL HEADS
K905739 · LZO
Zimmer, Inc.
Orthopedic · 73d
Cleared Mar 07, 1991
MAMEX DC AMI SL12/MG15
K905748 · IZH
Soredex, Inc.
Radiology · 71d
Cleared Mar 07, 1991
AUTO SUTURE(R) POLYMER SKIN GRAFT STAPLER*
K910586 · GDT
United States Surgical, A Division of...
General & Plastic Surgery · 24d
Cleared Mar 07, 1991
SUNTEX STERILE EXAM GLOVES
K910631 · LYY
P.T. Latexindo Prautama
General Hospital · 22d
Cleared Mar 07, 1991
BOSTON(R) BRAND LATEX EXAM GLOVES/HYPOALLERGENIC
K910660 · LYY
Boston Medical Corp.
General Hospital · 21d
Cleared Mar 07, 1991
AM GLOVES STERILE VINYL EXAMINATION
K910774 · LYZ
Am Gloves Co., Ltd.
General Hospital · 13d
Cleared Mar 07, 1991
JM GLOVES STERILE VINYL EXAMINATION
K910775 · LYZ
Jm Gloves Co., Ltd.
General Hospital · 13d
Cleared Mar 07, 1991
COMPANION SPEECH AID, MODEL 432
K910796 · ILQ
Companion Products Intl.
Physical Medicine · 9d
Cleared Mar 07, 1991
COMPANION SPEECH AID, MODEL 160
K910819 · ILQ
Companion Products Intl.
Physical Medicine · 9d
Cleared Mar 07, 1991
VPW 2877E6 X-RAY POWER SUPPLY
K910820 · IZO
Varian Canada, Inc.
Radiology · 10d
Cleared Mar 06, 1991
POLYURETHANE CONDOM
K902936 · HIS
Apex Medical Technologies, Inc.
Obstetrics & Gynecology · 246d
Cleared Mar 06, 1991
VIDEO ENDOSCOPE, RIGID
K903339 · HET
Medical Dynamics, Inc.
Obstetrics & Gynecology · 224d