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
140017–140040 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 10, 1987
0.1MM, 0.25MM, 0.5MM, ZOOM DERMATOLOGIC HANDPIECE
K870517 · GEX
Coherent Medical Group
General & Plastic Surgery · 64d
Cleared Apr 10, 1987
EZ TAC FILTER
K870531 · EXB
John F. Greer Co., Inc.
Gastroenterology & Urology · 63d
Cleared Apr 10, 1987
TONOMITOR(TM)
K870606 · FFT
Tonometrics Holdings SA C/O Mackeen...
Gastroenterology & Urology · 58d
Cleared Apr 10, 1987
HEART*AID 1000
K870622 · MKJ
Cardiac Resucitator Corp.
Cardiovascular · 57d
Cleared Apr 10, 1987
HR-3000 REUSE ADAPTOR
K870689 · LIF
Colorado Medical, Inc.
Gastroenterology & Urology · 50d
Cleared Apr 10, 1987
SURGICAL STARTER KIT
K870744
Devon Industries, Inc.
General & Plastic Surgery · 44d
Cleared Apr 10, 1987
7.5 MHZ TRANSRECTAL (ENDORECTAL) PROBE
K870748 · ITX
Philips Ultrasound, Inc.
Radiology · 44d
Cleared Apr 10, 1987
MD MONITORING/DIAGNOSTIC ELECTRODE
K870873 · DRX
Lectec Corp.
Cardiovascular · 38d
Cleared Apr 10, 1987
MEDSURG PERCUTANEOUS ASPIRATION BIOPSY (PAB) TRAY
K870892 · FSM
Medsurg Industries, Inc.
General & Plastic Surgery · 36d
Cleared Apr 10, 1987
MEDSURG BONE MARROW BIOPSY/ASPIRATION TRAY
K870894
Medsurg Industries, Inc.
General & Plastic Surgery · 36d
Cleared Apr 10, 1987
MODEL 435-03 SIDE HOOK IMPLANTABLE PACING LEAD
K870948 · DTB
Intermedics, Inc.
Cardiovascular · 32d
Cleared Apr 10, 1987
LCA 2000
K871034 · FTA
Vistek Corp.
General & Plastic Surgery · 24d
Cleared Apr 10, 1987
CAPD Y-ADMIN. SET USED W/INPERSOL BIOCAP ADMIN.
K871049 · KDJ
Abbott Laboratories
Gastroenterology & Urology · 24d
Cleared Apr 10, 1987
CAPD ADMIN. SET USED W/INPERSOL CAPD BIOCAP Y-ADM.
K871050 · KDJ
Abbott Laboratories
Gastroenterology & Urology · 24d
Cleared Apr 10, 1987
OMEGA EXTENDED MALAR AND OMEGA CONTOURED MALAR
K871074 · FWP
Omega Silicone, Inc.
General & Plastic Surgery · 23d
Cleared Apr 10, 1987
ANADIAS ZARA SYSTEM MALAR IMPLANTS
K871190 · FWP
Anadias, Inc.
General & Plastic Surgery · 17d
Cleared Apr 10, 1987
KOTEX PROFILE SHAPED MAXI PAD
K871210 · HHD
Kimberly-Clark Corp.
Obstetrics & Gynecology · 16d
Cleared Apr 10, 1987
KADIR HI-TORQUE GUIDE WIRE
K871297 · KOD
Argon Medical Corp.
Gastroenterology & Urology · 10d
Cleared Apr 09, 1987
MEDI-TECH SELECTIVE TORQUE CATHETER
K864118 · DQY
Medi-Tech, Inc.
Cardiovascular · 170d
Cleared Apr 09, 1987
Q5000 STRESS TEST MONITOR
K864504 · DPS
Quinton, Inc.
Cardiovascular · 146d
Cleared Apr 09, 1987
MODEL LS 860, CO2 LASER
K864562 · GEX
Cooper Lasersonics, Inc.
General & Plastic Surgery · 141d
Cleared Apr 09, 1987
MODEL LS 840, CO2 LASER
K864563 · GEX
Cooper Lasersonics, Inc.
General & Plastic Surgery · 141d
Cleared Apr 09, 1987
ACKRAD TDI SET
K864818 · KRB
Ackrad Laboratories
Cardiovascular · 121d
Cleared Apr 09, 1987
ADDITIONAL 13.4CM. FRENCH CATHETER INSERTION TRAY
K870675 · DQY
Quinton, Inc.
Cardiovascular · 49d