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
140593–140616 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 03, 1987
DISPOS GEL EXTERNAL PACING ELECTRODE/HI IMPEDANCE
K864987 · DRO
Medac, Inc.
Cardiovascular · 71d
Cleared Mar 03, 1987
ETP 180E NON-INVASIVE EXTERNAL PACEMAKER
K864988 · DRO
Medac, Inc.
Cardiovascular · 71d
Cleared Mar 03, 1987
ETP 180A NON-INVASIVE EXTERNAL PACEMAKER
K864989 · DRO
Medac, Inc.
Cardiovascular · 71d
Cleared Mar 03, 1987
ASPIRATING NEEDLE, CATALOG CODE #12006
K865079 · DWF
Dlp, Inc.
Cardiovascular · 64d
Cleared Mar 03, 1987
AMICI XENON REBREATHING SYSTEM*
K865084 · IYT
Amici, Inc.
Radiology · 63d
Cleared Mar 03, 1987
MODEL PY...U UNIPOLAR & BIPOLAR PACING LEAD
K870034 · DTB
Oscor Medical Corp.
Cardiovascular · 57d
Cleared Mar 03, 1987
MICRO-EAR CANAL IN-THE-EAR HEARING AID
K870079 · ESD
Micro-Ear Hearing Center, Inc.
Ear, Nose, Throat · 54d
Cleared Mar 03, 1987
MICRO-EAR FULL-CONCHA IN-THE-EAR HEARING AID
K870080 · ESD
Micro-Ear Hearing Center, Inc.
Ear, Nose, Throat · 54d
Cleared Mar 03, 1987
MICRO-EAR LOW-PROFILE IN-THE-EAR HEARING AID
K870081 · ESD
Micro-Ear Hearing Center, Inc.
Ear, Nose, Throat · 54d
Cleared Mar 03, 1987
BIOCHEM MICROSPAN 1040 OXIMETER
K870163 · DQA
Biochem International, Inc.
Anesthesiology · 48d
Cleared Mar 03, 1987
MODEL EV4543 MINIATURE TEMPORARY CARDIAC PACEMAKER
K870323 · DTE
Pace Medical
Cardiovascular · 34d
Cleared Mar 03, 1987
HYDROPHOBIC #6194418/HYDRAPHILIC #6104418 FILTERS
K870394 · FIB
Clinical Connections, Inc.
Gastroenterology & Urology · 32d
Cleared Mar 03, 1987
DAIG PACEMAKER LEAD ADAPTOR
K870562 · DTD
Daig Corp.
Cardiovascular · 21d
Cleared Mar 03, 1987
VEIN GRAFT EAR SCISSORS
K870756 · JZB
Treace Medical, Inc.
Ear, Nose, Throat · 5d
Cleared Mar 03, 1987
EAR LOOP
K870761 · JYQ
Treace Medical, Inc.
Ear, Nose, Throat · 5d
Cleared Mar 02, 1987
OMNIPLUS PHOTOSURGICAL LASER SYSTEM FOR OB-GYN
K863221 · HHR
Laserscope
Obstetrics & Gynecology · 193d
Cleared Mar 02, 1987
THERMAPAD
K864158 · KME
Avail-Southwest Division
General Hospital · 130d
Cleared Mar 02, 1987
S.C.T. MULTI PORT, INJECTION SITE
K864296 · FPA
Salt Creek Medical Technologies
General Hospital · 122d
Cleared Mar 02, 1987
IMZ INTRAMOBILE CYLINDER IMPLANT SYSTEM COMPONENTS
K870331 · EGG
Interpore Intl.
Dental · 33d
Cleared Mar 02, 1987
INTRAUTERINE INSEMINATION CATHETER
K870551 · HDR
Cook Ob/Gyn
Obstetrics & Gynecology · 20d
Cleared Mar 02, 1987
ALPHA-DENT PIT AND FISSURE SEALANT
K870579 · EBC
Wallace A. Erickson & Co.
Dental · 20d
Cleared Feb 27, 1987
THE INJECTOR
K862325 · KZH
American Medical Innovations, Inc.
General Hospital · 253d
Cleared Feb 27, 1987
KONTRON SIGMA 1SC DIGITAL ECHOCARDIOGRAPHY SYSTEM
K862686 · ITX
Kontron Instruments, Inc.
Radiology · 227d
Cleared Feb 27, 1987
PROFESSIONAL DISINFECTION SYSTEM (PDS)
K863346 · LPN
Ciba Vision Care
Ophthalmic · 182d