Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
171121–171144 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 27, 1978
RESCAL
K781759 · BZA
Diemolding Corp.
Anesthesiology · 42d
Cleared Nov 27, 1978
CLINAC 2500
K781872 · IYE
Varian Assoc., Inc.
Radiology · 24d
Cleared Nov 27, 1978
BREATHING CIRCUIT PRODUCTS, ANESTHESIA
K781908 · CAI
Hospitak, Inc.
Anesthesiology · 13d
Cleared Nov 22, 1978
DELTA-FLOW
K780479 · KRA
Tri-Delta Intl.
Cardiovascular · 240d
Cleared Nov 22, 1978
PROCAINAMIDE CALIBRATOR KIT
K780732 · DLJ
Vitek Systems, Inc.
Toxicology · 204d
Cleared Nov 22, 1978
RUBELISA TEST KIT
K780996 · GON
Microbiological Assoc.
Microbiology · 162d
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