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
76153–76176 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 29, 2002
LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL C2 LOW OPIATE & C3 LOW OPIATE MODELS...
K021415 · DIF
Bio-Rad
Chemistry · 26d
Cleared May 29, 2002
MODEL R1000 IR INSULIN PUMP, EZLINK SOFTWARE, SERMON SOFTWARE, R1000 IR...
K021439 · LZG
Animas Corp.
General Hospital · 23d
Cleared May 29, 2002
MODIFICATION TO EN-BLOC BIOPSY SYSTEM
K021577 · GEI
Neothermia Corp.
General & Plastic Surgery · 15d
Cleared May 28, 2002
ACCESS CARDIOSYSTEMS MANUAL DEFIBRILLATOR
K011461 · LDD
Access Cardiosystems, Inc.
Cardiovascular · 379d
Cleared May 28, 2002
NOSE BREATHE MOUTHPIECE FOR HEAVY SNORER
K013687 · LRK
Steven K. Sue
Dental · 202d
Cleared May 28, 2002
SELECT STIM
K020637 · IPF
Care Rehab and Orthopaedic
Physical Medicine · 90d
Cleared May 28, 2002
KSEA SCB MEDIA CONTROL
K020640 · FTA
KARL STORZ Endoscopy-America, Inc.
General & Plastic Surgery · 90d
Cleared May 28, 2002
EZ-SCOPE AN & EZ-SCOPE AN LITE
K020643 · IYX
Health Policy Resorters Group, LLC
Radiology · 90d
Cleared May 28, 2002
TSRH SPINAL SYSTEM
K020699 · MNH
Medtronic Sofamor Danek, Inc.
Orthopedic · 88d
Cleared May 28, 2002
PADPRO, MODEL 2502
K020743 · MKJ
Padpro, LLC
Cardiovascular · 83d
Cleared May 28, 2002
GYRUS ENT SOMNOPLASTY TISSUE COAGULATING ELECTRODE, MODEL 2420
K020778 · GEI
Gyrus Ent LLC
General & Plastic Surgery · 78d
Cleared May 28, 2002
NORAD NOCTURNAL ORAL AIRWAY DILATOR APPLIANCE
K020893 · LRK
Dennis R. Bailey, Dds
Dental · 70d
Cleared May 28, 2002
DETACHABLE MONOPOLAR EMG NEEDLE, MODELS 610-725, 610-737, 610-637, 610-744,...
K021118 · GXZ
Class A Ent.
Neurology · 50d
Cleared May 28, 2002
AROMACRYL
K021121 · EBI
Aromacryl, LLC
Dental · 50d
Cleared May 28, 2002
OSS LES PROXIMAL FEMORAL COMPONENT
K021380 · JDI
Biomet, Inc.
Orthopedic · 27d
Cleared May 24, 2002
14F X 55CM ASH SPLIT-CATH XL, MODEL ASPC55-XL
K020315 · MSD
Medcomp
Gastroenterology & Urology · 115d
Cleared May 24, 2002
IRRIGATING CANNULA
K020614 · OCX
Ca Guard, Ltd.
Gastroenterology & Urology · 88d
Cleared May 24, 2002
CURELLE, PREFERRED CURELLE, CUTEQ 2.5
K020628 · HHK
Bioteque America, Inc.
Obstetrics & Gynecology · 87d
Cleared May 24, 2002
SOFT K. AND SOFT K. TORIC (XYLOFICON A) SOFT (HYDROPHILLIC) KERATOCONUS...
K020642 · LPL
Soflex Contact Lens Industries , Ltd.
Ophthalmic · 86d
Cleared May 24, 2002
UNITY IS PATIENT VIEWER
K020661 · MSX
General Electric Medical Systems...
Cardiovascular · 84d
Cleared May 24, 2002
SYNCRUS INTERNAL CARDIOVERSION SYSTEM
K020701 · NHW
Guidant Corporation, Cardiac Surgery
Cardiovascular · 81d
Cleared May 24, 2002
SPECTRAL'S 2 IN 1 (TNI-MYO)
K020950 · MMI
Spectral Diagnostics, Inc.
Chemistry · 60d
Cleared May 24, 2002
G4 SLEEVED NAIL
K020962 · HSB
Biomet Manufacturing, Inc.
Orthopedic · 60d
Cleared May 24, 2002
B-F200 BRONCHOSCOPE WITH BSS-F21 ENDOSHEATH SYSTEM
K021344 · EOQ
Vision-Sciences, Inc.
Ear, Nose, Throat · 25d