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

Filters: Cleared only ×
176,076 results
77473–77496 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 18, 2002
EVTOOL MODEL # V. 1.0
K013535 · MUJ
3D Line USA, Inc.
Radiology · 87d
Cleared Jan 18, 2002
PLLA CANNULATED INTERFERENCE SCREW
K013685 · HWC
Future Medical Systems, Inc.
Orthopedic · 72d
Cleared Jan 18, 2002
ADVIA 1650 CHOLINESTERASE ASSAY
K013750 · DIH
Bayer Diagnostics Corp.
Chemistry · 66d
Cleared Jan 18, 2002
MODIFICATION TO: WINNER ST-2 STIMULATOR
K013770 · IPF
Rich-Mar Corp.
Physical Medicine · 66d
Cleared Jan 18, 2002
MODIFICATION TO: WINNER CM-2 MUSCLE STIMULATOR, TENS, THERAPEUTIC ULTRASOUND...
K013771 · IPF
Rich-Mar Corp.
Physical Medicine · 66d
Cleared Jan 18, 2002
AUTION MAX AX-4280 URINALYSIS SYSTEM
K013783 · KQO
International Remote Imaging Systems
Chemistry · 65d
Cleared Jan 18, 2002
TANSMIT/RECEIVE QUADRATURE BODY COIL 3.0T
K013894 · MOS
Philips Medical Systems North...
Radiology · 56d
Cleared Jan 18, 2002
CREATINE KINASE (CK-NAC)
K013912 · CGS
Jas Diagnostics, Inc.
Chemistry · 52d
Cleared Jan 18, 2002
PHILLIPS M1175A/76A/77A COMPONENT MONITORING SYSTEM
K014159 · DSI
Philips Medical Systems, Inc.
Cardiovascular · 30d
Cleared Jan 18, 2002
MODIFICATION TO DYNALINK .035 BILIARY SELF-EXPANDING STENT SYSTEM
K014184 · FGE
Guidant Corp.
Gastroenterology & Urology · 29d
Cleared Jan 18, 2002
PADPRO MODEL 2001, 2001-S, 2001-C, 2001-EPS
K014209 · MKJ
Padpro, LLC
Cardiovascular · 28d
Cleared Jan 18, 2002
ARTHROCARE CONTROLLER, PATIENT CABLE, FOOT CONTROL, POWER CORD
K014222 · GEI
Arthrocare Corp.
General & Plastic Surgery · 23d
Cleared Jan 18, 2002
BIO SPA INTELLIGENT
K992099 · IPF
Starbene
Physical Medicine · 942d
Cleared Jan 17, 2002
BIOLIGHT PCD
K011355 · ILY
Biolight International AB
Physical Medicine · 259d
Cleared Jan 17, 2002
RANDOX THEOPHYLLINE
K011771 · KLS
Randox Laboratories, Ltd.
Chemistry · 225d
Cleared Jan 17, 2002
DOXADENT DENTAL COMPOSITE, MODELS A, B, C, 12A, 12B, 12C, 6A, 6B, AND 6C
K011839 · EBF
Doxa Certex AB
Dental · 219d
Cleared Jan 17, 2002
ECG HOME
K012012 · DXH
H&C Medical Devices Spa
Cardiovascular · 203d
Cleared Jan 17, 2002
HEALTHLIFE OXYGEN CONCENTRATOR MODEL AS009
K012037 · CAW
Airsep Corp.
Anesthesiology · 202d
Cleared Jan 17, 2002
VAMOS ANESTHETIC GAS MONITOR
K012139 · CCK
Draeger Medical, Inc.
Anesthesiology · 191d
Cleared Jan 17, 2002
ERCHONIA PL2000
K012580 · NHN
Tuco Innovations, Inc.
Physical Medicine · 161d
Cleared Jan 17, 2002
INSPECTRA TISSUE SPECTROMETER SYSTEM (INSPECTRA), MODEL 325
K012759 · MUD
Hutchinson Technology, Inc.
Cardiovascular · 153d
Cleared Jan 17, 2002
MODIFIED TO LDL/HDL CHOL DIRECT KIT-P.N. 4005, 4103,4123
K012789 · JHO
Morax
Chemistry · 150d
Cleared Jan 17, 2002
PLAGIOCEPHALIC APPLIED PRESSURE ORTHOSIS P.A.P. ORTHOSIS
K012804 · MVA
Scott E Allen CP
Neurology · 149d
Cleared Jan 17, 2002
EXEL HUBER INFUSION SET WITH NEEDLELESS INJECTION SITE
K012879 · FPA
Exelint Intl. Co.
General Hospital · 142d