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
168121–168144 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 30, 1979
VMA BY COLUMN TEST
K791837 · CDF
Bio-Rad
Chemistry · 46d
Cleared Oct 30, 1979
RIONET HEARING AID HB-32
K791876 · ESD
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 60d
Cleared Oct 30, 1979
RIONET HEARING AID HB-32H
K791877 · ESD
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 60d
Cleared Oct 30, 1979
RIONET HEARING AID HB-67T
K791882 · ESD
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 60d
Cleared Oct 30, 1979
RIONET HEARING AID HI-60
K791884 · ESD
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 60d
Cleared Oct 30, 1979
19091-XXXXX SER. OF GLASS CAPILLARY COL.
K791893 · DII
Hewlett-Packard Co.
Toxicology · 35d
Cleared Oct 30, 1979
OCUTOME MODEL 8000
K791898 · HKP
Cooper Medical Devices Corp.
Ophthalmic · 35d
Cleared Oct 30, 1979
COULTER DIFF3 SYS. (COULTER #7400003)
K791903 · GKZ
Coulter Electronics, Inc.
Hematology · 35d
Cleared Oct 30, 1979
X-PAK
K791917 · HMX
Contemporary Surgical Systems, Inc.
Ophthalmic · 35d
Cleared Oct 30, 1979
ATMOS ENT TREATMENT SYSTEM SERVANT 3
K791934 · ETF
Jedmed Instrument Co.
Ear, Nose, Throat · 33d
Cleared Oct 30, 1979
ATMOS ENT CABINET PRACTICA 3
K791935 · ETF
Jedmed Instrument Co.
Ear, Nose, Throat · 33d
Cleared Oct 30, 1979
ATMOS ENT CABINET PRACTICA 2
K791936 · ETF
Jedmed Instrument Co.
Ear, Nose, Throat · 33d
Cleared Oct 30, 1979
PHENOL RED AGAR
K791939 · JSH
Isle Media and Sterile Products, Inc.
Microbiology · 29d
Cleared Oct 30, 1979
UREA AGAR
K791940 · JSI
Isle Media and Sterile Products, Inc.
Microbiology · 29d
Cleared Oct 30, 1979
PHENOL RED BROTH
K791941 · JSH
Isle Media and Sterile Products, Inc.
Microbiology · 29d
Cleared Oct 30, 1979
BILE ESCULIN AZIDE AGAR
K791942 · JSI
Isle Media and Sterile Products, Inc.
Microbiology · 29d
Cleared Oct 30, 1979
NUTRIENT AGAR
K791943 · JSG
Isle Media and Sterile Products, Inc.
Microbiology · 29d
Cleared Oct 30, 1979
NITRATE AGAR
K791944 · JSH
Isle Media and Sterile Products, Inc.
Microbiology · 29d
Cleared Oct 30, 1979
NITRATE BROTH
K791945 · JSF
Isle Media and Sterile Products, Inc.
Microbiology · 29d
Cleared Oct 30, 1979
OF BASAL MEDIUM
K791946 · JSH
Isle Media and Sterile Products, Inc.
Microbiology · 29d
Cleared Oct 30, 1979
PDC 304 DOUBLE SWAB CULTURE COLLECTION
K791953 · JTW
Precision Dynamics Corp.
Microbiology · 29d
Cleared Oct 30, 1979
REPL. PISTON FOR TROUTMAN CORNEAL PUNCH
K791988 · HNJ
Edward Weck, Inc.
Ophthalmic · 35d
Cleared Oct 30, 1979
ANTI NUCLEAR ANTIBODY TEST
K791995 · DHN
Meda Stat Diagnostics, Inc.
Immunology · 27d
Cleared Oct 30, 1979
(125I) TESTOSTERONE KIT
K791999 · CDZ
Radioassay Systems Laboratories, Inc.
Chemistry · 25d