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
169561–169584 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 26, 1979
BURRON VENTED NEEDLE
K790472 · GAA
National Patent Development Corp.
General & Plastic Surgery · 21d
Cleared Mar 26, 1979
MULTIPLE PINHOLE TOMOGRAPHIC COLLIMOTER
K790499 · IYX
Engineering Dynamics Corp.
Radiology · 13d
Cleared Mar 26, 1979
MOBILE X-RAY UNIT
K790511 · IZL
General X-Ray, Inc.
Radiology · 10d
Cleared Mar 26, 1979
PORTABLE X-RAY UNIT
K790512 · IZL
General X-Ray, Inc.
Radiology · 10d
Cleared Mar 26, 1979
MERSILENE SUTURES
K790534 · KRH
Hancock Laboratories, Inc.
Cardiovascular · 13d
Cleared Mar 23, 1979
AMBU SUCTION BOOSTER
K790035 · CBC
Narco Air-Shields
General Hospital · 77d
Cleared Mar 23, 1979
DEFIBRILLATOR INTERAL PADDLE TEST LOAD
K790394 · DRL
Physio-Control Corp.
Cardiovascular · 25d
Cleared Mar 23, 1979
MICROFLUSH
K790455 · KRA
Medex, Inc.
Cardiovascular · 18d
Cleared Mar 23, 1979
SERIES 7000
K790456 · BSZ
Narco Mckesson Co.
Anesthesiology · 17d
Cleared Mar 23, 1979
CARDIOCASSETTE II, AMBULATORY ECG SYSTEM
K790509 · DSH
Cambridge Instruments, Inc.
Cardiovascular · 8d
Cleared Mar 22, 1979
GENERATOR, R-WAVE
K790213 · IYY
Amr Co.
Radiology · 51d
Cleared Mar 22, 1979
NAD SCAVENGING RELIEF VALVE
K790333 · CBN
Draeger Medical, Inc.
Anesthesiology · 34d
Cleared Mar 22, 1979
SOMATOM SD
K790342 · JAK
Siemens Corp.
Radiology · 29d
Cleared Mar 22, 1979
KOTEX TUBE AND STICK TAMPON
K790385 · HEB
Kimberly-Clark Corp.
Obstetrics & Gynecology · 24d
Cleared Mar 22, 1979
ADULT ZEE-FRAME
K790410 · JAY
Equilibrated Bio Systems, Inc.
Anesthesiology · 24d
Cleared Mar 22, 1979
BURNETT-KETCHUM DYNAMIC HAND EXERCISER
K790527 · JFA
Maddak, Inc.
Physical Medicine · 7d
Cleared Mar 21, 1979
CARDIOPHONE
K781973 · DXY
North American Motronic
Cardiovascular · 114d
Cleared Mar 21, 1979
A.V. FISTULA NEEDLE SET
K782021 · FIE
Cordis Corp.
Gastroenterology & Urology · 106d
Cleared Mar 21, 1979
DRAPES, DISPOSABLE SURGICAL
K782051 · KKX
Marco Mfg.
General Hospital · 103d
Cleared Mar 21, 1979
CREAM, SIGNA
K782055 · GYB
Parker Laboratories, Inc.
Neurology · 100d
Cleared Mar 21, 1979
SPINAL SURGERY INSTRUMENTATION
K782061 · KWQ
Stuart Drug & Surgical Supply, Inc.
Orthopedic · 100d
Cleared Mar 21, 1979
RIA SYSTEM, PARATHYROID HORMONE
K782081 · CEW
Iso-Tex Diagnostics
Chemistry · 98d
Cleared Mar 21, 1979
PHASEAFILL
K782165 · EBF
Phasealloy
Dental · 85d
Cleared Mar 21, 1979
NEEDLE II, BURRON FILTER
K790060 · GAA
National Patent Development Corp.
General & Plastic Surgery · 70d