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
159769–159792 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 29, 1982
UV-A AND UV-B FLUORESCENT LAMPS
K828054
Zip Tan
Radiology · 60d
Cleared Sep 29, 1982
MAMMOMAT B AND BE
K828055
Siemens Medical Solutions USA, Inc.
Radiology · 30d
Cleared Sep 29, 1982
MODEL 4045 RADIONUCLIDE CALIBRATOR
K828249
Radcal Corp.
Radiology · 19d
Cleared Sep 28, 1982
SURGITA/MIZHO MICRONEUROSURGERY HEAD FR
K821772 · HBL
Downs Surgical , Ltd.
Neurology · 104d
Cleared Sep 28, 1982
MULTIPLE LEAD ARRHYTHMIA MODULE
K822030 · DSI
Marquette Electronics, Inc.
Cardiovascular · 78d
Cleared Sep 28, 1982
FIBEROPTIC LIGHT SOURCE W/RELATED ITEMS
K822265 · EBA
Kelleher Corp.
Dental · 61d
Cleared Sep 28, 1982
REPLAM HYDROXYAPATATITE
K822420 · FMF
Replam Corp.
General Hospital · 47d
Cleared Sep 28, 1982
PROTEMP
K822452 · EBG
Espe GmbH (Us)
Dental · 43d
Cleared Sep 28, 1982
COVALENT COAT RIA KIT
K822509 · CFP
Immuchem Corp.
Chemistry · 39d
Cleared Sep 28, 1982
MODEL UCG ASSAY
K822520 · JHI
Monoclonal Antibodies, Inc.
Chemistry · 36d
Cleared Sep 28, 1982
CUTANEOUS PRESSURE PLETHYSMOGRAPH
K822522 · DSB
Life Sciences Manufacturing, Inc.
Cardiovascular · 36d
Cleared Sep 28, 1982
MULTIPLE, ENT CABINET #448
K822531 · ETF
Midmark Corp.
Ear, Nose, Throat · 36d
Cleared Sep 28, 1982
MARK V
K822536 · DXT
Medrad, Inc.
Cardiovascular · 35d
Cleared Sep 28, 1982
NEEDLE CATHETER JEJUNOSTOMY KIT
K822565 · KNT
Bio-Research Associates, Inc.
Gastroenterology & Urology · 37d
Cleared Sep 28, 1982
LITHOTRIPTOR ELECTRODE 4.5F
K822585 · FFK
Monaghan Medical Corp.
Gastroenterology & Urology · 33d
Cleared Sep 28, 1982
PERCUTANEOUS CATHETER INTRODUCER SET
K822593 · DYB
Vertex Medical Corp.
Cardiovascular · 32d
Cleared Sep 28, 1982
POLYETHYLENE CARDIOVASCULAR CATHETER
K822594 · DQO
Vertex Medical Corp.
Cardiovascular · 32d
Cleared Sep 28, 1982
VESSEL DILATOR
K822595 · DRE
Vertex Medical Corp.
Cardiovascular · 32d
Cleared Sep 28, 1982
TEFLON PIGTAIL/PERCUTANEOUS CARDIOVAS
K822598 · DQO
Vertex Medical Corp.
Cardiovascular · 32d
Cleared Sep 28, 1982
ACID FAST QUALITY CONTROL SLIDES
K822604 · LJG
Medastat Scientific Corp.
Chemistry · 32d
Cleared Sep 28, 1982
ROOT CANAL REAMERS, TYPE K
K822620 · EKP
Union Broach, Div. Moyco Industries,...
Dental · 29d
Cleared Sep 28, 1982
ROOT CANAL FILES, TYPE K
K822621 · EKS
Union Broach, Div. Moyco Industries,...
Dental · 29d
Cleared Sep 28, 1982
ROOT CANAL FILES, TYPE H (HEDSTROM
K822622 · EKS
Union Broach, Div. Moyco Industries,...
Dental · 29d
Cleared Sep 28, 1982
NASAL SEPTAL BUTTONS
K822637 · LFB
Abco Dealers, Inc.
Ear, Nose, Throat · 28d