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
54505–54528 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 27, 2009
CAMLAB CRANIAL ORTHOSIS HELMET
K081787 · OAN
Biosculptor Corporation
Neurology · 217d
Cleared Jan 27, 2009
LEMAITRE TT TORTUOUS TRACKER INTRODUCER CATHETER DELIVERY SYSTEM
K081878 · DQY
LeMaitre Vascular, Inc.
Cardiovascular · 209d
Cleared Jan 27, 2009
APOLLO ANTERIOR CERVICAL PLATE SYSTEM
K082504 · KWQ
Apollo Spine, Inc.
Orthopedic · 151d
Cleared Jan 27, 2009
AEQUALIS HUMERAL NAIL SYSTEM
K082754 · HSB
Tornier
Orthopedic · 130d
Cleared Jan 27, 2009
HDS HI 1.54
K082799 · HQD
Paragon Vision Sciences
Ophthalmic · 126d
Cleared Jan 27, 2009
ACRYLIC HERBST SPLINT APPLIANCE
K083209 · LRK
Specialty Appliance Works, Inc.
Dental · 88d
Cleared Jan 27, 2009
NUGARD, SENSIFLEX PROCEDURE EXAMINATION GLOVES
K083337 · LYY
Terang Nusa Sdn Bhd
General Hospital · 76d
Cleared Jan 27, 2009
APIERON INSIGHT ENO SYSTEM
K083617 · MXA
Apieron, Inc.
Chemistry · 50d
Cleared Jan 26, 2009
GISH VISION BLOOD CARDIOPLEGIA WITH HA COATING
K081838 · DTR
Gish Biomedical, Inc.
Cardiovascular · 210d
Cleared Jan 26, 2009
BERICHROM HEPARIN LMW CALIBRATOR, BERICHROM HEPARIN LMW CONTROL 1, AND...
K083159 · JPA
Siemens Healthcare Diagnostics
Hematology · 91d
Cleared Jan 26, 2009
BERICHROM HEPARIN UF CALIBRATOR, BERICHROM HEPARIN UF CONTROL 1, AND...
K083175 · JPA
Siemens Healthcare Diagnostics
Hematology · 90d
Cleared Jan 26, 2009
ZMATCH BLOCK
K083201 · EIH
Dentaim Co., Ltd.
Dental · 88d
Cleared Jan 26, 2009
PANTHERA MECHANICAL WHEELCHAIR, MODELS S2, U2, BAMBINO, MICRO, BT
K083231 · IOR
Panthera Production AB
Physical Medicine · 84d
Cleared Jan 26, 2009
LANDLEX, MODEL: 402X
K083303 · INI
Besteam Technology, Inc.
Physical Medicine · 77d
Cleared Jan 26, 2009
CERCOM CEMENT
K083398 · EMA
Denali R&D Corporation
Dental · 70d
Cleared Jan 26, 2009
BEAU RX SCAR CARE GEL
K083718 · MDA
Beau RX Solutions, LLC
General & Plastic Surgery · 42d
Cleared Jan 26, 2009
GALAXY
K083874 · MNR
Respironics Inc., Sleep & Home...
Anesthesiology · 28d
Cleared Jan 23, 2009
COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM, MODEL WHF-314 (POWER-Q1000)
K080134 · IRP
Wonjin Mulsan Co., Ltd.
Physical Medicine · 371d
Cleared Jan 23, 2009
PRO-TECH DELIVERY SYSTEM ELECTRODES, MODEL TT-2000
K081279 · GXY
Transfer Technology
Neurology · 262d
Cleared Jan 23, 2009
MEDISIZE BLUE, MEDISIZE GREEN, MEDISIZE RED
K081536 · CAH
Medisize BV
General Hospital · 235d
Cleared Jan 23, 2009
EASYPLUS MINI R2N SELF MONITORING GLUCOSE TEST SYSTEM
K081796 · NBW
Eps Bio Technology Corp.
Chemistry · 212d
Cleared Jan 23, 2009
GISH TUBING AND CONNECTORS WITH HA COATING
K081881 · DWF
Gish Biomedical, Inc.
Cardiovascular · 205d
Cleared Jan 23, 2009
AIRGENT, MODEL AG7000010
K082138 · KZE
Perfaction, Inc.
General Hospital · 178d
Cleared Jan 23, 2009
BIO-SCREEN
K082668 · NXV
Addent, Inc.
Dental · 133d