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
155329–155352 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 03, 1984
ADJUSTABLE FORK RETRACTOR
K833604 · KAL
Microtek Medical, Inc.
Ear, Nose, Throat · 83d
Cleared Jan 03, 1984
CUPPED FORCEPS
K833605 · KAE
Microtek Medical, Inc.
Ear, Nose, Throat · 83d
Cleared Jan 03, 1984
IMPLANT MEASURING GAUGE
K833606 · JYJ
Microtek Medical, Inc.
Ear, Nose, Throat · 83d
Cleared Jan 03, 1984
MCGEE FORCEPS
K833607 · KAE
Microtek Medical, Inc.
Ear, Nose, Throat · 83d
Cleared Jan 03, 1984
BOS-CM40,50 HOLDER & RESERVOIR BAG
K833670 · DTZ
American Bentley
Cardiovascular · 77d
Cleared Jan 03, 1984
GLYCOGLOBIN KIT
K833805 · LCP
Endocrine Sciences Products
Hematology · 63d
Cleared Jan 03, 1984
TAMPONADE BALLOON CUFF
K833859 · GCP
American Endoscopy, Inc.
Gastroenterology & Urology · 57d
Cleared Jan 03, 1984
PENASE
K833888 · MDB
Oxoid U.S.A., Inc.
Microbiology · 55d
Cleared Jan 03, 1984
BICARBOLYTE HEMO-DIAL
K833896 · KOC
Edlaw Pharmaceuticals, Inc.
Gastroenterology & Urology · 50d
Cleared Jan 03, 1984
NEGATIVE PRESSURE ARTERIAL BLOOD
K833905 · KOC
Erika, Inc.
Gastroenterology & Urology · 50d
Cleared Jan 03, 1984
NEGATIVE PRESSURE VENOUS BLOOD LINE
K833906 · KOC
Erika, Inc.
Gastroenterology & Urology · 50d
Cleared Jan 03, 1984
UMI PERCUTANEOUS TRANSHEPATIC CHOLAN
K833937 · FGE
Universal Medical Instrument Corp.
Gastroenterology & Urology · 49d
Cleared Jan 03, 1984
NOVEL DISPENSER/PACKAGE
K833955 · EIY
Dentsply Intl.
Dental · 48d
Cleared Jan 03, 1984
SELECTIVE STREPTOCOCCUS AGAR
K834005 · JSJ
Micro Media Laboratories
Microbiology · 43d
Cleared Jan 03, 1984
BRUCELLA MEDIA
K834006 · JSG
Micro Media Laboratories
Microbiology · 43d
Cleared Jan 03, 1984
DERMATOPHYTE TEST MEDIUM
K834010 · JSJ
Micro Media Laboratories
Microbiology · 43d
Cleared Jan 03, 1984
SARNS CARDIOPLEGIA CANNULA Y
K834025 · DWF
3M Health Care, Sarns
Cardiovascular · 42d
Cleared Jan 03, 1984
INFANT VENT CATHETER 12001 W/SIDE VENT
K834039 · DWF
Dlp, Inc.
Cardiovascular · 41d
Cleared Jan 03, 1984
MSI-HC HEMATOLOGY CONTROL
K834043 · JPK
Medical Specialties, Inc.
Hematology · 41d
Cleared Jan 03, 1984
LEGIONELLA DIFFERENTIATION DISK
K834067 · GRO
Remel Co.
Microbiology · 39d
Cleared Jan 03, 1984
CEB
K834068 · JSJ
Remel Co.
Microbiology · 39d
Cleared Jan 03, 1984
MIDDLEBROOK & COHN 7H11 AGAR BASE
K834204 · JSH
Acumedia Manufacturers, Inc.
Microbiology · 29d
Cleared Jan 03, 1984
MIDDLEBROOK & COHN 7H10 AGAR BASE
K834205 · JSH
Acumedia Manufacturers, Inc.
Microbiology · 29d
Cleared Jan 03, 1984
EUGONIC AGAR
K834206 · JSG
Acumedia Manufacturers, Inc.
Microbiology · 29d