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
172225–172248 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 28, 1978
BIOPHYSICAL MONITORING SYSTEM
K780425 · DXJ
Gould, Inc.
Cardiovascular · 42d
Cleared Apr 28, 1978
FIBER OPTIC HANDPIECE
K780483 · EFB
Syntex Corp.
Dental · 32d
Cleared Apr 28, 1978
STIKSEP-T3 KIT
K780486 · CEE
Nuclear Diagnostics, Inc.
Chemistry · 32d
Cleared Apr 28, 1978
GAMMA STIK 125I T3 UPTAKE KIT
K780492 · CDP
Alpha Gamma Laboratory
Chemistry · 32d
Cleared Apr 28, 1978
GENTAMICIN RIA KIT
K780516 · DJB
Antibodies, Inc.
Immunology · 29d
Cleared Apr 28, 1978
ULTRANOVAR, DENTAL U.V. CURING LAMP
K780518 · EBZ
Demetron Research Corp.
Dental · 28d
Cleared Apr 28, 1978
CRYPTOCOCCAL ANTIGEN LATEX AGG. SYSTEM
K780526 · GMD
I M, Inc.
Microbiology · 28d
Cleared Apr 28, 1978
AUTOMATED PHYSIOLOGIC PROFILER
K780530 · DQK
Bd Becton Dickinson Vacutainer...
Cardiovascular · 24d
Cleared Apr 28, 1978
AORTIC PUMP
K780567 · DWS
Ethicon, Inc.
Cardiovascular · 22d
Cleared Apr 28, 1978
UNISTAT OXIMETER
K780625 · DQA
American Optical Corp.
Anesthesiology · 14d
Cleared Apr 28, 1978
DRY SILVER PROCESSOR MODEL 1226
K780640 · DSF
Honeywell, Inc.
Cardiovascular · 11d
Cleared Apr 28, 1978
RADIOASSAY FOR TOTAL SERUM THYROXINE
K780644 · CDX
Nuclear Diagnostics, Inc.
Toxicology · 11d
Cleared Apr 28, 1978
AIR-PWOERED COLDRILL
K780646 · EKX
Medishield, Inc.
Dental · 11d
Cleared Apr 28, 1978
HEARING AID, EARETTE
K780654 · ESD
Oticon Corp.
Ear, Nose, Throat · 9d
Cleared Apr 28, 1978
IMPRESSION TRAY
K780678 · EHY
Rocky Mountain Orthodontics, Inc.
Dental · 4d
Cleared Apr 27, 1978
TOTAL KNEE SYSTEM
K780299 · HRY
Richard'S Medical Equip., Inc.
Orthopedic · 64d
Cleared Apr 27, 1978
COLOPLAST-DURASEAL OSTOMY APPLIANCE
K780409 · EZS
C.R. Bard, Inc.
Gastroenterology & Urology · 45d
Cleared Apr 27, 1978
BODY WARMER
K780426 · IMD
Q-Matic Corp.
Physical Medicine · 41d
Cleared Apr 27, 1978
H.P. MEDICAL GRADE SILICONE TUBING
K780470 · KDL
Dow Corning Corp. Healthcare...
Gastroenterology & Urology · 36d
Cleared Apr 27, 1978
HUMIDIFIER FILTER
K780535 · CAH
Hudson Oxygen Therapy Sales Co.
General Hospital · 24d
Cleared Apr 27, 1978
AQUAPAK PREFILLED HUMIDIFIER
K780562 · BTT
Respiratory Care, Inc.
Anesthesiology · 20d
Cleared Apr 27, 1978
TEMPERATURE INDICATOR
K780580 · KPD
Respiratory Care, Inc.
General Hospital · 17d
Cleared Apr 27, 1978
SHADOW-CATHS
K780643 · FJS
Quinton, Inc.
Gastroenterology & Urology · 10d
Cleared Apr 27, 1978
DAYSTAR SELECTRA & SELECTRA/ORBITER
K780666 · FSY
Castle Co.
General & Plastic Surgery · 48d