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
58873–58896 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 17, 2007
ARTHROCARE SPINEWAND
K072089 · GEI
Arthrocare Corp.
General & Plastic Surgery · 18d
Cleared Aug 17, 2007
HEARTWAY POWER MOBILITY SCOOTER, PF6
K072104 · INI
Heartway Medical Products Co., Ltd.
Physical Medicine · 17d
Cleared Aug 17, 2007
M3 MONITOR
K072131 · DRY
Spectrum Medical , Ltd.
Cardiovascular · 15d
Cleared Aug 17, 2007
VICTORY THREE WHEEL SCOOTER, MODEL: SC610
K072165 · INI
Pride Mobility Products Corp.
Physical Medicine · 11d
Cleared Aug 16, 2007
VENDYS MODEL 5000 B/BC
K060980 · DQK
Endothelix, Inc.
Cardiovascular · 493d
Cleared Aug 16, 2007
INSIGHT DISCOVERY
K063447 · IKN
Fasstech
Neurology · 274d
Cleared Aug 16, 2007
REBOUND HRD
K063671 · FTL
Minnesota Medical Development, Inc.
General & Plastic Surgery · 248d
Cleared Aug 16, 2007
RIVULET VENTRICULAR AND SNAP SHUNT AND CONVERTIBLE VENTRICULAR CATHETERS,...
K063836 · JXG
Medtronic Neurosurgery
Neurology · 233d
Cleared Aug 16, 2007
COMCASET-P SAFETY IV CATHETER
K070020 · FOZ
Pitango Medical, Ltd.
General Hospital · 225d
Cleared Aug 16, 2007
VITRIFREEZE MEDIUM
K070135 · MQL
Fertipro NV
Obstetrics & Gynecology · 212d
Cleared Aug 16, 2007
CRYOSEAL FS APPLICATOR SYSTEM
K071126 · FMF
Thermogenesis Corp.
General Hospital · 115d
Cleared Aug 16, 2007
MODIFICATION TO NEUVIZ DUAL MULTI-SLICE CT SCANNER SYSTEM
K071308 · JAK
Neusoft Medical Systems Co., Ltd.
Radiology · 99d
Cleared Aug 16, 2007
B. BRAUN PISTON SYRINGES AND OMNICAN AND OMNIFIX INSULIN SYRINGES
K071459 · FMF
B.Braun Medical, Inc.
General Hospital · 83d
Cleared Aug 16, 2007
XEBRA DICOM IMAGE BROWSER
K071894 · LLZ
Hx Technologies, Inc.
Radiology · 38d
Cleared Aug 15, 2007
ACCELI DBM FAMILY PRODUCTS, 0.5CC, 1CC, 2.5CC, 5CC, 10CC, 15CC, 30CC
K061880 · MQV
Isotis NV
Orthopedic · 408d
Cleared Aug 15, 2007
APEX HCLA ACETABULAR CUP LINERS
K062489 · LPH
Omnilife Science
Orthopedic · 355d
Cleared Aug 15, 2007
SPECTROLYSE PAI-1, MODEL 101201
K063323 · GGP
American Diagnostica, Inc.
Hematology · 285d
Cleared Aug 15, 2007
HEATMARKER TIME TEMPERATURE INDICATOR
K063759 · OCI
Temptime Corporation
General Hospital · 239d
Cleared Aug 15, 2007
HEMOSIL RECOMBIPLASTIN 2G
K070005 · GJS
Instrumentation Laboratory CO
Hematology · 224d
Cleared Aug 15, 2007
MICROSURGEON MICROWAVE TISSUE ABLATION DEVICE, MODEL MTAD-100
K070023 · NEY
Microsurgeon, Inc.
General & Plastic Surgery · 224d
Cleared Aug 15, 2007
INSCOPE TISSUE ANCHORS, KNOTTING ELEMENTS AND TISSUE ANCHOR AND KNOTTING...
K070151 · OCW
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 211d
Cleared Aug 15, 2007
KD-795 WRIST MEASUREMENT ELECTRONIC BLOOD PRESSURE MONITOR
K070826 · DXN
Kodon(Tianjin)Electronic&Electrical...
Cardiovascular · 142d
Cleared Aug 15, 2007
KD-595 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
K070828 · DXN
Kodon(Tianjin)Electronic&Electrical...
Cardiovascular · 142d
Cleared Aug 15, 2007
CRANIOCLAMP BIOABSORBABLE CRANIAL BONE FLAP FIXATION SYSTEM
K071138 · GXR
Prosurg, Inc.
Neurology · 152d