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
149041–149064 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 28, 1985
MODEL 483-02 PACING LEAD
K844269 · DTB
Intermedics, Inc.
Cardiovascular · 143d
Cleared Mar 28, 1985
MODEL 480-01 PACING LEAD
K844270 · DTB
Intermedics, Inc.
Cardiovascular · 143d
Cleared Mar 28, 1985
MODEL 479-01 PACING LEAD
K844271 · DTB
Intermedics, Inc.
Cardiovascular · 143d
Cleared Mar 28, 1985
MODEL 473-03 PACING LEAD
K844272 · DTB
Intermedics, Inc.
Cardiovascular · 143d
Cleared Mar 28, 1985
POST-AURICULAR HEARING AID MODEL PE 600 PPC
K844859 · ESD
Phonic Ear, Inc.
Ear, Nose, Throat · 104d
Cleared Mar 28, 1985
POST-SURICULAR HEARING AID PE 600CD
K844863 · ESD
Phonic Ear, Inc.
Ear, Nose, Throat · 104d
Cleared Mar 28, 1985
STILLE SCANDIA OPERATING TABLES RC 3000,1100
K850168 · GDC
Stille-Werner (Usa), Inc.
General & Plastic Surgery · 71d
Cleared Mar 28, 1985
OHMEDA BIOX 3700 PULSE OXIMETER
K850494 · DPZ
Ohmeda Medical
Anesthesiology · 48d
Cleared Mar 27, 1985
PATHFINDER CARDIOVASCULAR CATHETER
K844555 · DQO
Argon Medical Corp.
Cardiovascular · 126d
Cleared Mar 27, 1985
KONTRON MINIMON 7132 PATIENT MONITOR
K844732 · DRT
Kontron Instruments, Inc.
Cardiovascular · 113d
Cleared Mar 27, 1985
KONTRON MINIMON 7131 PATIENT MONITOR
K844733 · DRT
Kontron Instruments, Inc.
Cardiovascular · 113d
Cleared Mar 27, 1985
POST-AURICULAR HEARING AID MODEL PE 600CHD
K844860 · ESD
Phonic Ear, Inc.
Ear, Nose, Throat · 103d
Cleared Mar 27, 1985
POST-AURICULAR HEARING AID MODEL PE 600PPCL
K844861 · ESD
Phonic Ear, Inc.
Ear, Nose, Throat · 103d
Cleared Mar 27, 1985
CORDIS ENCOR PERVENOUS ATRIAL & VENTRICULAR LEADS
K844970 · DTB
Cordis Corp.
Cardiovascular · 93d
Cleared Mar 27, 1985
MICRO VOLUME DOUBLE LINE EXTENSION SET
K850061 · FPA
Travenol Laboratories, S.A.
General Hospital · 78d
Cleared Mar 27, 1985
TISSUE TEMP PROBE
K850083 · FLL
Pat O. Daily
General Hospital · 76d
Cleared Mar 27, 1985
POST AURICULAR HEARING AIDS STAR 33PP, 44,55F &
K850186
Robert Bosch Corp.
Gastroenterology & Urology · 68d
Cleared Mar 27, 1985
ELECATH OPEN TIP BIPOLAR PACING CATHETER
K850324 · LDF
Electro-Catheter Corp.
Cardiovascular · 58d
Cleared Mar 27, 1985
NU-CATH EMERGENCY KIT
K850398 · FOZ
Intl. Medical Devices , Ltd.
General Hospital · 54d
Cleared Mar 27, 1985
ATS ACOUSTIC STANDOFF - WATER BAG
K850422 · ITX
Ats Laboratories, Inc.
Radiology · 51d
Cleared Mar 27, 1985
FLOSSAGE - ELECTRIC TOOTHFLOSSER
K850562 · JEQ
Mcspadden, Inc.
Dental · 43d
Cleared Mar 27, 1985
BLOOD OXYGENATOR MODEL NO. MAX-5
K850630 · DTZ
American Bentley
Cardiovascular · 36d
Cleared Mar 27, 1985
ACME LOW-PROFILE CHAIR SCAL 7300
K851014 · FRW
Acme Medical Scale Co.
General Hospital · 15d
Cleared Mar 26, 1985
EIGEN FLORO-STOR FS-100
K844375 · JAA
Eigen Video
Radiology · 133d