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
170281–170304 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 22, 1978
MEDICAL GRADE SILICONE ELASTOMER TUBING
K781087 · FPK
Mcghan Medical Corp.
General Hospital · 146d
Cleared Nov 22, 1978
125I-ALDOSTERONE RIA DIAG. KIT
K781504 · CJM
Abbott Laboratories
Chemistry · 84d
Cleared Nov 22, 1978
CUTTER RESIFLEX URINE METER
K781521 · KNX
Cutter Laboratories, Inc.
Gastroenterology & Urology · 78d
Cleared Nov 22, 1978
VOLUMETRIC CONTROLLER MODEL 310
K781589 · FLN
Imed Corp.
General Hospital · 65d
Cleared Nov 22, 1978
RIA, CORTISOL KIT
K781730 · CGR
Radioassay Systems Laboratories, Inc.
Chemistry · 40d
Cleared Nov 22, 1978
EXTRACTOR, SABIAN FOREIGN BODY
K781737
Sabian Corp.
Cardiovascular · 41d
Cleared Nov 22, 1978
REAGENT, HDL
K781740 · CHH
Fisher Scientific Co., LLC
Chemistry · 36d
Cleared Nov 22, 1978
LDH REAGENT SYSTEM
K781765 · CFJ
American Monitor Corp.
Chemistry · 37d
Cleared Nov 22, 1978
ALBUMIN REAGENT
K781773 · CIX
Gilford Diagnostics
Pathology · 40d
Cleared Nov 22, 1978
TOTAL PROTEIN
K781774 · CEK
Gilford Diagnostics
Chemistry · 40d
Cleared Nov 22, 1978
LDH
K781775 · CFJ
Gilford Diagnostics
Chemistry · 40d
Cleared Nov 22, 1978
REAGENT, FIREFLY #395
K781807 · JOZ
Chrono-Log Corp.
Hematology · 28d
Cleared Nov 22, 1978
NEUROPAC ULTRA II
K781829 · GZJ
Medical Devices, Inc.
Neurology · 23d
Cleared Nov 22, 1978
PLATE, LD PRESUMPTO
K781856 · JSE
Anaerobe Systems
Microbiology · 16d
Cleared Nov 22, 1978
DROPPER, CEPTI-SEAL LAVTOPHENOL
K781868 · KEQ
Marion Laboratories, Inc.
Microbiology · 19d
Cleared Nov 22, 1978
DROPPER, CEPTI-SEAL KOH SOLUTION
K781869 · KEQ
Marion Laboratories, Inc.
Microbiology · 19d
Cleared Nov 22, 1978
COLLINS PEDALMATE 2
K781889 · ISD
Warren E. Collins, Inc.
Physical Medicine · 15d
Cleared Nov 22, 1978
EAR STOPPLES FOR NOISE ATTENTION
K781907 · EWD
Crown Delta Corp.
Ear, Nose, Throat · 8d
Cleared Nov 22, 1978
POUCHES AND TUBING, MEDI-SEAL
K781924 · FRG
Medicare Industries, Inc.
General Hospital · 12d
Cleared Nov 22, 1978
POUCHES, GAS STERILIZATION
K781925 · FRG
Medicare Industries, Inc.
General Hospital · 12d
Cleared Nov 21, 1978
CALCULATOR, WITH CHARGER
K781838 · BWF
C.R. Bard, Inc.
Anesthesiology · 25d
Cleared Nov 20, 1978
CAMSCAN SYSTEM
K781845 · DSI
American Optical Corp.
Cardiovascular · 19d
Cleared Nov 16, 1978
BLOOD PRESSURE CUFF COVER
K781671 · DXQ
David Cott Co.
Cardiovascular · 44d
Cleared Nov 16, 1978
BLOOD PRESSURE DEVICE, 400 SERIES
K781906 · DXN
Med-Tek Corp.
Cardiovascular · 3d