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
117457–117480 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 13, 1992
OR340 INTRAOPERATIVE ULTRASOUND BIOPSY NEEDLE GUID
K913987 · ITY
Codman & Shurtleff, Inc.
Radiology · 221d
Cleared Apr 13, 1992
GAMBRO ENGSTROM Y-FILTER WITH EDITH FLEX (1500F)
K914271 · CAN
C.G.H. Medical, Inc.
Anesthesiology · 202d
Cleared Apr 13, 1992
BARTRONIX IN-BED ACTIVITY MONITOR
K914859 · KMI
Bartronix
General Hospital · 167d
Cleared Apr 13, 1992
QUICVAGE PLUS
K914908 · KDH
Autovage
Gastroenterology & Urology · 164d
Cleared Apr 13, 1992
BIOMET NTS FEMORAL COMPONENTS
K920161 · JDI
Biomet, Inc.
Orthopedic · 90d
Cleared Apr 13, 1992
ATLAS 2000 VASCULAR ROAD MAPPING SYSTEM
K920434 · IZI
Squires & Assoc., Inc.
Radiology · 69d
Cleared Apr 13, 1992
DISPLAY PROCESSOR - MODEL IDP5100
K920550 · JAA
Perkins Mfg. Co.
Radiology · 67d
Cleared Apr 13, 1992
X-RAY DIAGNOSTIC TABLE YSF-200-30-90
K920722 · IXR
Shimadzu Medical Systems
Radiology · 55d
Cleared Apr 10, 1992
PRESS 1 PRESS 2 9220 UPDATING OF THE MODULE
K912816 · DSK
S & W Medico Teknik
Cardiovascular · 297d
Cleared Apr 10, 1992
ALLOY SCALPEL HANDPIECES
K914197 · GEX
L.A.S.E.R., Inc.
General & Plastic Surgery · 204d
Cleared Apr 10, 1992
ANESTHETIC GAS MONITOR TYPE 1304, MODIFIED
K914295 · CBQ
Bruel & Kjaer
Anesthesiology · 214d
Cleared Apr 10, 1992
TALLEY MICRO SYSTEM/TALLEY RIPPLEBED
K914775 · FNM
Talley Group, Ltd.
General Hospital · 170d
Cleared Apr 10, 1992
AKCESS-CATH KIT
K914826 · LFJ
Akcess Medical Products, Inc.
Gastroenterology & Urology · 168d
Cleared Apr 10, 1992
CARBON DIOXIDE CO2 LASER
K915656 · GEX
Ion Laser Technology
General & Plastic Surgery · 114d
Cleared Apr 10, 1992
PWB LUMBOSACRAL SPINE SYSTEM
K920116 · KWP
Cross Medical Products, Inc.
Orthopedic · 88d
Cleared Apr 10, 1992
ND:YAG SURGICAL LASER
K920120 · GEX
Carl Zeiss, Inc.
General & Plastic Surgery · 88d
Cleared Apr 10, 1992
SCULPTURED ENDOSTAT
K920584 · GEX
Laserscope
General & Plastic Surgery · 60d
Cleared Apr 10, 1992
EME MP3000 MONITORING AND DIAGNOSTIC RESTING ECG
K920867 · DRX
Electro Medical Equipment Co., Inc.
Cardiovascular · 45d
Cleared Apr 10, 1992
IMAGE PRO URODYNAMICS MEASURING SYST, MODIFICATION
K920991 · FAP
Browne Medical Systems, Inc.
Gastroenterology & Urology · 56d
Cleared Apr 10, 1992
PROFILE PLUS URODYNAMICS MEASURING SYST, MODIFIED
K920992 · FAP
Browne Medical Systems, Inc.
Gastroenterology & Urology · 56d
Cleared Apr 10, 1992
MODEL 8100 URODYNAMICS MEASURING SYSTEM
K921047 · FAP
Browne Medical Systems, Inc.
Gastroenterology & Urology · 56d
Cleared Apr 09, 1992
PEDIA-THOR THORACOSTOMY KIT
K913540 · FMF
Intl. Medical Devices , Ltd.
General Hospital · 244d
Cleared Apr 09, 1992
NEO-THOR THORACOSTOMY KIT
K913541 · FMF
Intl. Medical Devices , Ltd.
General Hospital · 244d
Cleared Apr 09, 1992
SERIM RESIDUAL FORMALDEHYDE REAGENT STRIPS
K914123 · LIF
Serim Research Corp.
Gastroenterology & Urology · 209d