FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

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

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175,820 results
134785–134808 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 25, 1988
GPS/WGPS/PREVIEW GP
K874854 · IYO
Labsonics, Inc.
Radiology · 272d
Cleared Aug 25, 1988
HYSTEROSCOPE AUTONOM 4992
K880314 · HIH
Richard Wolf Medical Instruments Corp.
Obstetrics & Gynecology · 212d
Cleared Aug 25, 1988
XACT NEISSERIA
K880511 · JSX
Austin Biological Laboratories
Microbiology · 198d
Cleared Aug 25, 1988
VESSEL DILATOR AND INTRODUCER SHEATH
K882238 · DRE
Ideal Medical, Inc.
Cardiovascular · 90d
Cleared Aug 25, 1988
HORIZON 2000 PULSE OXIMETRY AND MODULE
K882273 · DQA
Mennen Medical, Inc.
Anesthesiology · 86d
Cleared Aug 25, 1988
UNIFAST ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST
K882325 · GFO
Sclavo, Inc.
Hematology · 80d
Cleared Aug 25, 1988
STIHLER ASTOTHERM IFT 200, IFT 220
K882361 · LGZ
Stihler Electronic, C/O Worldwide...
General Hospital · 79d
Cleared Aug 25, 1988
METATECH MICROCLIP APPLICATOR
K882367 · DWS
Metatech Corp.
Cardiovascular · 78d
Cleared Aug 25, 1988
SYSMEX K-1000 18 PARAMETER, AUTO. HEMA ANALYZER
K882370 · GKZ
Toa Medical Electronics USA, Inc.
Hematology · 78d
Cleared Aug 25, 1988
COAG-I ANALYZER, ALPHA MODEL
K882444 · JPA
Cardiovascular Diagnostic Services
Hematology · 72d
Cleared Aug 25, 1988
MEDTRONIC MODELS 4057/4557 ENDOCARDIAL PACING LEAD
K882452 · DTB
Medtronic Vascular
Cardiovascular · 72d
Cleared Aug 25, 1988
COAG-I PT TEST CARD
K882456 · GJS
Cardiovascular Diagnostic Services
Hematology · 72d
Cleared Aug 25, 1988
30 IV EXTENSION SET W/TWO MALE LUER LOCKS
K882503 · FPA
Churchill Medical Systems, Inc.
General Hospital · 69d
Cleared Aug 25, 1988
MULTIPLE SPECTACLE FRAMES
K883100 · HQZ
Metal Optics U.S.A., Inc.
Ophthalmic · 34d
Cleared Aug 25, 1988
HISTO-CHECK SLIDES
K883208 · LJG
Val Tech Diagnostics, Inc.
Microbiology · 27d
Cleared Aug 25, 1988
RABBIT PLASMA FIBRINOGEN (RPF) SUPPLEMENT
K883333 · JTL
Immuno-Mycologics, Inc.
Microbiology · 16d
Cleared Aug 25, 1988
SURGICAL CONNECTING TUBES
K883473 · GAZ
Westmark, Sterile Packing Systems,...
General Hospital · 9d
Cleared Aug 25, 1988
OWREN'S VERONAL BUFFER
K883484 · JPA
Helena Laboratories
Hematology · 9d
Cleared Aug 24, 1988
BREATHING CIRCUIT W/HEATED WIRE
K880769 · BZE
Dryden Corp.
Anesthesiology · 177d
Cleared Aug 24, 1988
GAMBRO MULTIPURPOSE SYSTEM MPS-10
K881270 · FII
Gambro, Inc.
Gastroenterology & Urology · 153d
Cleared Aug 24, 1988
VIGGO INSUFLON
K881767 · FOZ
Ohmeda Medical
General Hospital · 121d
Cleared Aug 24, 1988
MODEL SSD-870 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM
K881834 · IYO
Ge Medical Systems Information...
Radiology · 117d
Cleared Aug 24, 1988
522 INTELLIGENT PUMP
K882159 · FRN
Kendall Mcgaw Laboratories, Inc.
General Hospital · 93d
Cleared Aug 24, 1988
ACUMED 9000 ETCO(2) MONITOR
K882661 · CCK
Acumed Technologies, Inc.
Anesthesiology · 57d