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
90985–91008 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 12, 1997
RESOUND STEALTH CIC
K974081 · ESD
Resound Corp.
Ear, Nose, Throat · 44d
Cleared Dec 12, 1997
HI-69E, HI-69N, HI-69P
K974129 · ESD
Rockwin Corp.
Ear, Nose, Throat · 39d
Cleared Dec 12, 1997
HOSPITAL'S CLAMP
K974227 · HFW
Gps
Obstetrics & Gynecology · 30d
Cleared Dec 12, 1997
HOSPITAL'S SPEC
K974228 · HIB
Gps
Obstetrics & Gynecology · 30d
Cleared Dec 12, 1997
RESOUND DIGITAL 2000-BT W/DIGITAL 2000-DF (DIGITAL PROGRAMMER)
K974257 · ESD
Resound Corp.
Ear, Nose, Throat · 29d
Cleared Dec 12, 1997
CIRCUMCISION TRAY, CAT. NO. 70340
K974286 · HFX
Trinity Laboratories, Inc.
Obstetrics & Gynecology · 28d
Cleared Dec 12, 1997
UNITRON MODEL F/X PROGRAMMABLE (MINI BTE)
K974338 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 24d
Cleared Dec 12, 1997
UNITRON MODEL SOUND F/XD PROGRAMMABLE
K974339 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 24d
Cleared Dec 12, 1997
UNITRON MODEL SOUND F/XP PROGRAMMABLE MINI BTE
K974340 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 24d
Cleared Dec 12, 1997
NON-STERILE POWDER-FREE LATEX EXAMINATION GLOVES COLORED
K974518 · LYY
Yty Industry (Manjung) Sdn Bhd
General Hospital · 10d
Cleared Dec 11, 1997
FAVP: FEMORAL ARTERY VASCULAR PAD - MODEL NUMBER PAD2EK-01, PAD2EK-2X,...
K964663 · DXC
Rmds, Inc.
Cardiovascular · 385d
Cleared Dec 11, 1997
HYDROFLOEX HD HYSTEROSCOPIC DISTENTION SYSTEM
K970078 · HIG
Davol Inc., Sub. C. R. Bard, Inc.
Obstetrics & Gynecology · 336d
Cleared Dec 11, 1997
URIDYLTRANSFERASE KIT, 50 HOUR (80-4000-13K)
K970277 · KQP
Astoria-Pacific, Inc.
Chemistry · 322d
Cleared Dec 11, 1997
IVT 0.014 PTFE-COATED TRACKWIRE
K971688 · DQX
Boston Scientific /International...
Cardiovascular · 218d
Cleared Dec 11, 1997
GREATBATCH SCIENTIFIC MR COMPATIBLE LAPAROSCOPES AND OPERATING LAPAROSCOPES
K972280 · GCJ
Wilson Greatbatch Technologies, Inc.
General & Plastic Surgery · 176d
Cleared Dec 11, 1997
GERM TRAPPER SUCTION TUBE HOLDER
K972372 · JOL
Rzv Medical Specialties, Inc.
General Hospital · 169d
Cleared Dec 11, 1997
CRIT-LINE MONITOR (CLMIII)
K972470 · MQS
In-Line Diagnostics Corp.
Gastroenterology & Urology · 163d
Cleared Dec 11, 1997
COURIER ST BALLOON DILATATION CATHETER
K972744 · LIT
Boston Scientific Corp
Cardiovascular · 141d
Cleared Dec 11, 1997
MEDLINE PREMIUM LEG BAG, MEDLINE FABRIC BAC LEG BAG, MEDLINE URINARY LEG BAG
K972887 · KNX
Medline Industries, Inc.
Gastroenterology & Urology · 128d
Cleared Dec 11, 1997
SMITH & NEPHEW IMAGES CYSTOURETHROSCOPES AND ACCESSORIES, SMITH & NEPHEW...
K972979 · FBO
Smith & Nephew, Inc.
Gastroenterology & Urology · 122d
Cleared Dec 11, 1997
EXPRESSE AND PREMIER POWERED BREAST PUMPS
K973501 · HGX
Ameda Medizintechnik AG
Obstetrics & Gynecology · 86d
Cleared Dec 11, 1997
SOWELL COBALT-CHROME METAL ALLOY
K973567 · EJH
C.K. International Trading
Dental · 83d
Cleared Dec 11, 1997
SOWELL NICKEL-CHROME NON-PRECIOUS METAL ALLOY
K973568 · EJH
C.K. International Trading
Dental · 83d
Cleared Dec 11, 1997
SOWELL NICKEL-CHROME-MOLYBDENUM ALLOY
K973569 · EJH
C.K. International Trading
Dental · 83d