FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
83977–84000 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 10, 1999
TERATECH, MODEL 2000 IMAGING IMAGING
K992505 · IYO
Teratech Corp.
Radiology · 106d
Cleared Nov 10, 1999
POLYGRAF ID, POLYGRAM '98 ESOPHAGEAL MANOMETRY TESTING APPLICATION, MODELS...
K992713 · FFX
Medtronic Functional Diagnostics A/S
Gastroenterology & Urology · 90d
Cleared Nov 10, 1999
PRIMEAIRE
K992722 · CAF
Thayer Medical Corp.
Anesthesiology · 89d
Cleared Nov 10, 1999
E.CAM COMPUTER
K992731 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 89d
Cleared Nov 10, 1999
AKRON ATP9 TRACTION MACHINE
K992733 · ITH
Huntleigh Technology, Inc.
Physical Medicine · 89d
Cleared Nov 10, 1999
VACUUM ASSIST STABILIZER
K992833 · MWS
Cardio Thoracic Systems
Cardiovascular · 79d
Cleared Nov 10, 1999
LEVELSENS - FLEXIBLE, MODEL 201110, LEVELSENS - RIGID, MODEL 201070
K992857 · DTW
Rocky Mountain Research, Inc.
Cardiovascular · 77d
Cleared Nov 10, 1999
COMPONENTS FOR CARDIOVASCULAR PROCEDURE KIT
K992906 · DTL
Olson Medical Sales, Inc.
Cardiovascular · 72d
Cleared Nov 10, 1999
RESPIRONICS TOTAL FACE MASK
K992969 · BZD
Respironics, Inc.
Anesthesiology · 68d
Cleared Nov 10, 1999
METRX SYSTEM
K993021 · HRX
Surgical Navigation Technologies, Inc.
Orthopedic · 63d
Cleared Nov 10, 1999
MILLENNIUM INFANT VENTILATOR
K993167 · CBK
Sechrist Industries, Inc.
Anesthesiology · 49d
Cleared Nov 10, 1999
MICROMEDICS S&T PARTIAL OSSICULAR REPLACEMENT PROSTHESIS
K993234 · ETB
Micromedics, Inc.
Ear, Nose, Throat · 44d
Cleared Nov 10, 1999
AUTOJET 2 (NON-FIXED NEEDLE TYPE)
K993385 · KZH
Owen Mumford USA, Inc.
General Hospital · 33d
Cleared Nov 10, 1999
PIKOS 01, PIKOS E01, PIKOS 01-B, PIKOS E01-B, PIKOS 01-A, PIKOS E01-A
K993434 · DXY
Biotronik, Inc.
Cardiovascular · 29d
Cleared Nov 10, 1999
POWDERED LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM)
K993458 · LYY
Sri Johani Sdn. Bhd.
General Hospital · 28d
Cleared Nov 10, 1999
LIGHT-CORE
K993488 · EBF
Bisco, Inc.
Dental · 26d
Cleared Nov 10, 1999
ZURICH TITANIUM OSSICULAR REPLACEMENT SYSTEM
K993583 · ETA
Stryker Corp.
Ear, Nose, Throat · 19d
Cleared Nov 10, 1999
SITE-RITE 3 ULTRASOUND SYSTEM
K993624 · IYO
Dymax Corp
Radiology · 15d
Cleared Nov 09, 1999
TED 60T OXYGEN ANALYZER
K990457 · CCL
Teledyne Electronic Technologies
Anesthesiology · 270d
Cleared Nov 09, 1999
LIGHT DIAGNOSTICS SIMULFLUOR HSV 1/2 IMMUNOFLUORECENCE ASSAY
K991880 · GQN
Light Diagnostics
Microbiology · 160d
Cleared Nov 09, 1999
ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM
K991907 · CZW
Bayer Corp.
Immunology · 155d
Cleared Nov 09, 1999
BAYER ADVIA INTEGRATED MODULAR SYSTEM (IMS)
K992136 · CIT
Bayer Corp.
Chemistry · 138d
Cleared Nov 09, 1999
1818 TENS UNIT
K992709 · GZJ
138 Medical Supplies, Inc.
Neurology · 90d
Cleared Nov 09, 1999
EBT ULTRAFAST CT SCANNER SYSTEM
K992740 · JAK
Imatron, Inc.
Radiology · 85d