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
169177–169200 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 31, 1979
DENTAL HANDPIECE
K790601 · EFB
Venture Technology, Inc.
Dental · 66d
Cleared May 31, 1979
DERMATOPHYTIN O
K790671 · JXB
Diagnostica, Inc.
Microbiology · 55d
Cleared May 31, 1979
ASPERGILLUS FUMIGATUS, ASPERGILLUS FLAVU
K790672 · JWT
Diagnostica, Inc.
Microbiology · 55d
Cleared May 31, 1979
SIEMENS CARDIOSTAT 701
K790794 · DPS
Elmed, Inc.
Cardiovascular · 37d
Cleared May 31, 1979
PULPTESTER MODEL 2001
K790799 · EAT
Analytic Technology
Dental · 37d
Cleared May 31, 1979
LS-8 VISICORDER
K790825 · DSF
Honeywell, Inc.
Cardiovascular · 31d
Cleared May 31, 1979
COAGULATION ARP
K790826 · JPK
Helena Laboratories
Hematology · 31d
Cleared May 31, 1979
SNAP-WAY
K790843 · DZB
Northwest Orthodontics, Inc.
Dental · 29d
Cleared May 31, 1979
T.E.N.S.* SINGLE-USE ELECTRODE
K790850 · GXY
3M Company
Neurology · 27d
Cleared May 31, 1979
CARDIAC PULSE GENERATOR, 16 SERIES
K790867 · DXY
Telectronics, Inc.
Cardiovascular · 24d
Cleared May 31, 1979
TRACOR MODEL RA-411 MICROPROCESSOR
K790903 · EWO
Tracor Instruments, Inc.
Ear, Nose, Throat · 20d
Cleared May 31, 1979
LIFEPATCH ECG ELECTRODES
K790959 · DRX
Physio-Control Corp.
Cardiovascular · 9d
Cleared May 29, 1979
KAGER TRAPDUST
K790085 · LDQ
Kager Intl.
General & Plastic Surgery · 133d
Cleared May 29, 1979
FEVER TESTER
K790532 · KPD
Maddak, Inc.
General Hospital · 75d
Cleared May 29, 1979
INTRAVASCULAR ADMINISTRATION SET
K790582 · FPA
Y
General Hospital · 63d
Cleared May 29, 1979
REVISED BATTERY CHARGER
K790689 · FPL
Vickers America Medical Corp.
General Hospital · 49d
Cleared May 29, 1979
PROCTOSCOPE #501
K790856 · GCF
C. Intl.
Gastroenterology & Urology · 25d
Cleared May 29, 1979
RT-HOOD
K790860 · FOG
Plastics Supplies & Products
Anesthesiology · 22d
Cleared May 25, 1979
TEST KIT, IIF-AMA
K790295 · DBM
Medica Corp.
Immunology · 105d
Cleared May 25, 1979
TXOCELL-IHA REAGENT SYSTEM
K790460 · GMM
Calbiochem-Behring Corp.
Microbiology · 81d
Cleared May 25, 1979
RIA KIT, PROSTATIC ACID
K790580 · JFH
Monitor Science Corp.
Chemistry · 59d
Cleared May 25, 1979
ACCUTRON POLLUTION REDUCER
K790638 · BSJ
Parker Laboratories, Inc.
Anesthesiology · 56d
Cleared May 25, 1979
EMIT CFA THYROXINE ASSAY
K790686 · KLI
Syva Co.
Chemistry · 44d
Cleared May 25, 1979
MEDTRONIC MODELS 6907/6901
K790766 · DTB
Medtronic Vascular
Cardiovascular · 36d