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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
41161–41184 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 29, 2013
740 SELECT
K130411 · MWI
Cas Medical Systems, Inc.
Cardiovascular · 99d
Cleared May 29, 2013
ENTERPRISE ECG ANALYSIS / INTERPRETATION SOFTWARE
K131045 · DQK
Cardiac Designs, LLC
Cardiovascular · 44d
Cleared May 29, 2013
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR
K131121 · DXN
Health & Life Co., Ltd.
Cardiovascular · 37d
Cleared May 29, 2013
ADROIT GUIDING CATHETER
K131225 · DQY
Cordis Corp., A Johnson & Johnson Co.
Cardiovascular · 29d
Cleared May 29, 2013
NIO COLOR 3MP LED
K131295 · LLZ
Barco N.V.
Radiology · 23d
Cleared May 29, 2013
ETIAM PACS COMPONENTS
K131392 · LLZ
Etiam S.A.S.U.
Radiology · 15d
Cleared May 28, 2013
VITAL SUTURES SUTUREX CIRUGIA PERUANA SUTUMED
K123034 · GAR
Unilene Sac
General & Plastic Surgery · 242d
Cleared May 28, 2013
FINGER PULSE OXIMETER
K123801 · DQA
Shenzhen Kingyield Technology Co., Ltd.
Anesthesiology · 169d
Cleared May 28, 2013
CORIN TRINITY ACETABULAR SYSTEM WITH EXTRA-LONG HEADS
K130343 · LZO
Corin USA
Orthopedic · 106d
Cleared May 24, 2013
POLYMED THERAPEUTICS FASTEP DIPSTICK DRUGS OF ABUSE SCREEN DEVICE AND...
K121065 · DKZ
Polymed Therapeutics, Inc.
Toxicology · 413d
Cleared May 24, 2013
STAY FRESH SKIN FOLD MANAGEMENT TEXTILE
K121898 · FRL
Quick-Med Technologies, Inc.
General Hospital · 329d
Cleared May 24, 2013
SYNTHES SYNCAGE EVOLUTION SPACER
K122639 · MAX
Synthes USA Products, LLC
Orthopedic · 268d
Cleared May 24, 2013
PROVIDENCE CERVICAL CAGE
K122801 · ODP
Providence Medical Technology, Inc.
Orthopedic · 253d
Cleared May 24, 2013
ANTEGRADE FEMORAL NAIL
K123569 · HSB
Advanced Orthopaedic Solutions, Inc.
Orthopedic · 185d
Cleared May 24, 2013
INTRABLOCK BIOBALL HIP SYSTEM (IBS)
K123619 · LZO
Merete Medical GmbH
Orthopedic · 182d
Cleared May 24, 2013
PIPELINE KNEE SYSTEM
K123692 · JWH
Pipeline Orthopedics
Orthopedic · 172d
Cleared May 24, 2013
AMES THERAPY DEVICE
K123746 · IKK
Ames Technology, Inc.
Physical Medicine · 169d
Cleared May 24, 2013
WATER-FILLED TEETHER
K123855 · KKO
Solid Toys Ind. , Ltd.
Dental · 161d
Cleared May 24, 2013
MTM CLEAR ALIGNER IN-OFFICE
K123925 · NXC
Dentsply International, Inc.
Dental · 155d
Cleared May 24, 2013
ZENOLUX
K130184 · EIH
Wieland Dental + Technik GmbH & Co. KG
Dental · 119d
Cleared May 24, 2013
SLEEPWEAVER ANEW FULL FACE SOFT CLOTH PAP MASK
K130481 · BZD
Circadiance, LLC
Anesthesiology · 88d
Cleared May 24, 2013
MOBICATH BI-DIRECTIONAL GUIDING SHEATH
K130559 · DYB
Great Batch Medical
Cardiovascular · 81d
Cleared May 24, 2013
CORIN METAFIX HIP STEM
K130634 · LZO
Corin USA
Orthopedic · 74d
Cleared May 24, 2013
RAPIDCROSS PTA RAPID EXCHANGE BALLOON DILATATION CATHETER
K130911 · LIT
Ev3, Inc.
Cardiovascular · 52d