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
149113–149136 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 22, 1985
GST SYSTEM THERMOGRAPHIC APPLICATION
K842878 · LHQ
Gst Laboratories of Ca, Inc.
Radiology · 242d
Cleared Mar 22, 1985
HEMATOLOGY CONTROL UNI-CELL 5, UNI-CELL 7 & 8
K844897 · JPK
Medical Specialties Laboratories
Hematology · 95d
Cleared Mar 22, 1985
QUANTICEL HHR + TWO HUMAN HEMATOLOGY W/PLATELETS
K844927 · JPK
Bhp Diagnostix, Inc.
Hematology · 93d
Cleared Mar 22, 1985
QUANTICEL HHR TWO HUMAN HEMATOLOGY REFERENCE
K844928 · JPK
Bhp Diagnostix, Inc.
Hematology · 93d
Cleared Mar 22, 1985
KELLER CEPHALOMETRIC DEVICE
K850197 · IWY
Gary D. Keller
Radiology · 63d
Cleared Mar 22, 1985
AMERICAN PHARMASEAL STERILE I.V. START KIT
K850266
American Pharmaseal Div. Ahsc
General & Plastic Surgery · 58d
Cleared Mar 22, 1985
SUPLEX & SUPLEX DILUENT
K850302 · JSK
Pro-Lab, Inc.
Microbiology · 59d
Cleared Mar 22, 1985
CINE RADIOGRAPHIC FILM PROCESSOR M-45CR
K850421 · IXX
The Allen Products Co.
Radiology · 46d
Cleared Mar 22, 1985
CUE FERTILITY MONITOR
K850579 · NGE
Zetek, Inc.
Toxicology · 37d
Cleared Mar 22, 1985
SURGI-PAP KIT
K850676 · HHT
Surgipath Medical Industries, Inc.
Obstetrics & Gynecology · 29d
Cleared Mar 22, 1985
MUELLER HINTON AGAR
K850715 · JTZ
Rapid City Regional Hospital, Inc.
Microbiology · 28d
Cleared Mar 22, 1985
SELENITE F BROTH
K850716 · JSJ
Rapid City Regional Hospital, Inc.
Microbiology · 28d
Cleared Mar 22, 1985
AMIES TRANSPORT MEDIA
K850717 · JSM
Rapid City Regional Hospital, Inc.
Microbiology · 28d
Cleared Mar 22, 1985
DNASE TEST MEDIA, CHRISTENSEN'S UREA AGAR
K850719 · JSH
Rapid City Regional Hospital, Inc.
Microbiology · 28d
Cleared Mar 22, 1985
EOSIN METHYLENE BLUE AGAR, SS AGAR, XLD AGAR 6.5%
K850720 · JSI
Rapid City Regional Hospital, Inc.
Microbiology · 28d
Cleared Mar 22, 1985
KLIGER'S IRON AGAR, SIM MEDIA, MRVP MEDIUM, BILE E
K850721 · JSH
Rapid City Regional Hospital, Inc.
Microbiology · 28d
Cleared Mar 22, 1985
MARTIN LEWIS AGAR
K850722 · JTY
Rapid City Regional Hospital, Inc.
Microbiology · 28d
Cleared Mar 22, 1985
SABOURAUD'S DEXTROSE AGAR, BORDET GENGOU AGAR, MYC
K850723 · JSI
Rapid City Regional Hospital, Inc.
Microbiology · 28d
Cleared Mar 22, 1985
COBAS FP REAGENTS FOR CARBAMAZEPINE
K850807 · KLT
Roche Diagnostic Systems, Inc.
Chemistry · 23d
Cleared Mar 21, 1985
CUSTOM STERILE PROCEDURE KITS
K842356
Sterile Design, Inc.
General & Plastic Surgery · 279d
Cleared Mar 21, 1985
ACUFEX ARTHROSCOPIC SHAVER
K844130 · HSZ
Acufex Microsurgical, Inc.
Orthopedic · 149d
Cleared Mar 21, 1985
TITERTEK MULTISKAN MCC
K844418 · JJQ
Flow Laboratories, Inc.
Chemistry · 126d
Cleared Mar 21, 1985
TITERTEK MULTISKAN MSS/340
K844419 · JJQ
Flow Laboratories, Inc.
Chemistry · 126d
Cleared Mar 21, 1985
DART DAILY AIR REMOVAL TEST
K844512 · JOJ
American Sterilizer Co.
General Hospital · 121d