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
154873–154896 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 04, 1984
HODGE DECOMPRESSION TUBE
K834258 · KNT
Inmed Corp.
Gastroenterology & Urology · 59d
Cleared Feb 04, 1984
TRANS-PACE
K834262 · DRO
Micromedical Devices, Inc.
Cardiovascular · 58d
Cleared Feb 04, 1984
ISLAMI GASTROINTESTINAL TUBE
K834268 · KNT
Biosearch Medical Products, Inc.
Gastroenterology & Urology · 58d
Cleared Feb 04, 1984
SOFTIP CATHETER
K834275 · DQO
Angiomedics, Inc.
Cardiovascular · 58d
Cleared Feb 04, 1984
INSPIRON LIQUID OXYGEN SYSTEM
K834290 · BYJ
Inspiron Corp.
Anesthesiology · 58d
Cleared Feb 04, 1984
ADULT INCONTINENCE PAD
K834295 · EYQ
Procter & Gamble Mfg. Co.
Gastroenterology & Urology · 58d
Cleared Feb 04, 1984
ADULT INCONTINENCE BRIEF
K834296 · EYQ
Procter & Gamble Mfg. Co.
Gastroenterology & Urology · 58d
Cleared Feb 04, 1984
THROMBOLYTIC ACTIVITY TEST
K834301 · GJA
Bio/Data Corp.
Hematology · 57d
Cleared Feb 04, 1984
CCS MODEL AV-102 IMPLANTABLE A-V DATA
K834342 · DTB
Cardiac Control Systems, Inc.
Cardiovascular · 54d
Cleared Feb 04, 1984
BHCG-CHECK
K834346 · JHJ
Diagnostic Technology, Inc.
Immunology · 54d
Cleared Feb 04, 1984
CARDIOTOMY RESERVORS BCR-3000/3500-Q-120
K834373 · DTN
American Bentley
Cardiovascular · 54d
Cleared Feb 04, 1984
GASTROINTESTINAL SHEATH BRUSH
K834402 · FDX
Hobbs Medical, Inc.
Gastroenterology & Urology · 52d
Cleared Feb 04, 1984
INJECTION NEEDLE
K834403 · FBK
Bobbs Medical, Inc.
Gastroenterology & Urology · 52d
Cleared Feb 04, 1984
ERCP CANNULA
K834414 · ODD
Hobbs Medical, Inc.
Gastroenterology & Urology · 51d
Cleared Feb 04, 1984
TEMPERATURE SENSING FOLEY CATHETER
K834438 · KOD
C.R. Bard, Inc.
Gastroenterology & Urology · 47d
Cleared Feb 04, 1984
INJECTION AIDE UNIT FOR DIAGETICS
K834440 · KZH
Gottinger Co.
General Hospital · 47d
Cleared Feb 04, 1984
COAXIAL BALLOON GASTROESOPHAGEAL DILA
K834451 · KNQ
Thomas J. Fogarty, M.D.
Gastroenterology & Urology · 47d
Cleared Feb 04, 1984
DIAGNOSTIC RADIOLOGY CATHETERS
K834459 · DQO
American Edwards Laboratories
Cardiovascular · 47d
Cleared Feb 04, 1984
NEPHROSTOMY/BILIARY DRAINAGE BAG
K834476 · LJE
Vertex Medical Corp.
Gastroenterology & Urology · 46d
Cleared Feb 04, 1984
INJECTION CAP
K834480 · FOZ
Bd Becton Dickinson Vacutainer...
General Hospital · 46d
Cleared Feb 04, 1984
ESKA JONAS SILICON-SILVER PENILE
K834504 · FAE
Dacomed Corp.
Gastroenterology & Urology · 45d
Cleared Feb 04, 1984
RENAFLO AVF SET FOR HEMODIALYSIS
K834510 · KNZ
Renal Systems, Inc.
Gastroenterology & Urology · 45d
Cleared Feb 04, 1984
PRESERV SAF FIXATIVE 15ML
K834566 · LIO
Preventive Diagnostics Corp.
Microbiology · 38d
Cleared Feb 04, 1984
FIBRINOGEN TEST
K834571 · KQJ
Diatech, Inc.
Hematology · 37d