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
62329–62352 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 06, 2006
ADVIA IMS CPSA CONTROL
K061137 · JJY
Bayer Healthcare, LLC
Immunology · 73d
Cleared Jul 06, 2006
BAYER ADVIA IMS PSA CALIBRATOR AND ADVIA IMS CPSA CALIBRATORS
K061139 · JIT
Bayer Healthcare, LLC
Immunology · 73d
Cleared Jul 06, 2006
SYSMEX AUTOMATED HEMATOLOGY ANALYZER, XT-SERIES
K061150 · GKZ
Sysmex America, Inc.
Hematology · 72d
Cleared Jul 06, 2006
ACTIVAPIN
K061164 · HTY
Bioretec, Ltd.
Orthopedic · 71d
Cleared Jul 06, 2006
ACHTUNG BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4207
K061181 · NBW
Taidoc Technology Corporation
Chemistry · 70d
Cleared Jul 06, 2006
DIMENSION VISTA IGA FLEX REAGENT CARTRIDGE ASSAY
K061338 · CFN
Dade Behring, Inc.
Immunology · 52d
Cleared Jul 06, 2006
ACCESS TPO ANTIBODY, AND ACCESS TPO ANTIBODY CALIBRATORS, MODELS A12985 AND...
K061382 · JZO
Beckman Coulter, Inc.
Immunology · 49d
Cleared Jul 06, 2006
GRENGLOO
K061481 · DYH
Ormco Corp.
Dental · 37d
Cleared Jul 06, 2006
ALLOFIX ANCHOR, 5.0 MM ANCHOR
K061498 · JDW
Musculoskeletal Transplant Foundation
Orthopedic · 36d
Cleared Jul 06, 2006
SMITH & NEPHEW COMPETITOR DEUCE FEMORAL COMPONENTS
K061569 · NPJ
Smith & Nephew, Inc.
Orthopedic · 30d
Cleared Jul 06, 2006
FORYOU POWERED WHEELCHAIR, MODEL FC-100
K061693 · ITI
Foryou Technology Co., Ltd.
Physical Medicine · 21d
Cleared Jul 05, 2006
OCULASE MD
K052354 · GEX
Biolase Technology, Inc.
General & Plastic Surgery · 310d
Cleared Jul 05, 2006
BARRIERPLUS GOLD POWDER-FREE SYNTHETIC POLYISOPRENE SURGICAL GLOVES
K053406 · KGO
Barriermed Glove Co.
General Hospital · 210d
Cleared Jul 05, 2006
AXYALOOP NONABSORBABLE BONE ANCHOR
K060970 · JDR
Axya Medical, Inc.
Orthopedic · 89d
Cleared Jul 05, 2006
LIGAFIX INTERFERENCE SCREW
K061262 · HWC
Sciences For Bio Materials
Orthopedic · 61d
Cleared Jul 05, 2006
ANCHOR BAND SUTURING SYSTEM, MODEL SR-AB
K061386 · GAT
Anulex Technologies, Inc.
General & Plastic Surgery · 48d
Cleared Jul 05, 2006
DIMENSION VISTA SYSTEM ENZYME2 CALIBRATOR, MODEL KC320
K061390 · JIX
Dade Behring, Inc.
Chemistry · 48d
Cleared Jul 05, 2006
COLLAWOUND DRESSING
K061474 · KGN
Collamatrix Co., Inc.
General & Plastic Surgery · 36d
Cleared Jul 05, 2006
LEKSELL GAMMAPLAN
K061540 · IWB
Elekta Instrument AB
Radiology · 30d
Cleared Jul 05, 2006
MEDCARE MECHANICAL WHEELCHAIR, MODELS MC-281S & MC-200S
K061694 · IOR
Medcare Manufacturing, Inc.
Physical Medicine · 20d
Cleared Jul 03, 2006
MYKRES SPINAL SYSTEM
K051704 · MNI
Showa Ika Kohgyo Co., Ltd.
Orthopedic · 374d
Cleared Jul 03, 2006
STAXX FX SYSTEM
K053336 · NDN
Spine Wave, Inc.
Orthopedic · 214d
Cleared Jul 03, 2006
VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL REAGENT PACK AND CALIBRATORS AND...
K060480 · CGR
Ortho-Clinical Diagnostics
Chemistry · 130d
Cleared Jul 03, 2006
EASYTAC ANCHOR. EASYTAC DELIVERY SYSTEM
K060494 · GDW
Medchannel, LLC
General & Plastic Surgery · 129d