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
160201–160224 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 10, 1982
BI-LEVEL ASSAYED TUMOR MARKER & ANTIN
K821026 · JJY
Ortho Diagnostic Systems, Inc.
Chemistry · 119d
Cleared Aug 10, 1982
SYSTEM ONE OXYGEN CONCENTRATOR
K821393 · CAW
Marathon
Anesthesiology · 91d
Cleared Aug 10, 1982
THE ARTIFICIAL URINARY SPHINCTER
K821627 · FAG
American Medical Systems, Inc.
Gastroenterology & Urology · 69d
Cleared Aug 10, 1982
THE INFLATABLE PENILE PROSTHESIS
K821628 · FAE
American Medical Systems, Inc.
Gastroenterology & Urology · 69d
Cleared Aug 10, 1982
SURGITEK PERCUTANEOUS NEPHROST. STENT
K821776 · LJE
Medical Engineering Corp.
Gastroenterology & Urology · 54d
Cleared Aug 10, 1982
PIGTAIL NASAL CATHETERS
K821817 · FGE
American Endoscopy, Inc.
Gastroenterology & Urology · 50d
Cleared Aug 10, 1982
CONPHAR SILICONE FEEDING TUBE
K821825 · KNT
Conphar, Inc.
Gastroenterology & Urology · 49d
Cleared Aug 10, 1982
ASSURE-MALE EXTERNAL INCONTINCE CATHETER
K821848 · KNX
Medical Design & Manufacturing Corp.
Gastroenterology & Urology · 49d
Cleared Aug 10, 1982
PENTAX CHOLEDOCHOFIBERSCOPE, #FCD-15A
K821974 · FBN
Pentax Precision Instrument Corp.
Gastroenterology & Urology · 39d
Cleared Aug 10, 1982
SHERIDAN/HVT,CF, UNCUFFED
K822082 · BTR
Sheridan Catheter Corp.
Anesthesiology · 29d
Cleared Aug 10, 1982
ALCON INDIRECT OPHTHALMOSCOPE
K822104 · HLI
Alcon Laboratories
Ophthalmic · 22d
Cleared Aug 10, 1982
OPHTHALMIC KNIFE
K822112 · HNN
Sharpoint, Inc.
Ophthalmic · 22d
Cleared Aug 10, 1982
SCANNER 560 ULTRASOUND SCANNER
K827713
Pie Data, Inc.
Radiology · 49d
Cleared Aug 10, 1982
DIGITAL FLUOROGRAPHIC X-RAY SYSTEM
K827760
General Electric Co.
Radiology · 20d
Cleared Aug 10, 1982
MED-X MODEL 301 X-RAY FILTER
K827761
Bfi- Medical Waste Systems
Radiology · 29d
Cleared Aug 10, 1982
RADIOGRAPHIC FILM ILLUMINATOR
K827762
Brandt Industries, Inc.
Radiology · 28d
Cleared Aug 06, 1982
PACE* AID MODEL 50
K820507 · DRO
Cardiac Resucitator Corp.
Cardiovascular · 162d
Cleared Aug 06, 1982
HEART *AID, #80
K820609 · DRO
Cardiac Resucitator Corp.
Cardiovascular · 151d
Cleared Aug 06, 1982
MEDTRONIC #6993
K820989 · DTB
Medtronic Vascular
Cardiovascular · 121d
Cleared Aug 06, 1982
HEART AID #90
K821152 · DRO
Cardiac Resucitator Corp.
Cardiovascular · 102d
Cleared Aug 06, 1982
MPI MON-IT II, SMART SAFETY SYSTEM
K821169 · GEI
Medical Plastics, Inc.
General & Plastic Surgery · 102d
Cleared Aug 06, 1982
MELOLIN
K821246 · NAB
Smith & Nephew, Inc.
General & Plastic Surgery · 99d
Cleared Aug 06, 1982
KONTRON LITWAK-KOFFSKY OBTURATED CANNU
K821316 · DWF
Kontron Instruments, Inc.
Cardiovascular · 94d
Cleared Aug 06, 1982
SNYDER DEBRIBEMENT SYSTEM LDP-1
K821321 · BTA
Snyder Laboratories, Inc.
General & Plastic Surgery · 94d