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
63769–63792 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 24, 2006
B. BRAUN 0.2 MICRON FILTER
K052773 · FMF
B.Braun Medical, Inc.
General Hospital · 113d
Cleared Jan 24, 2006
OPTO GLOBAL DIGITAL FUNDUS CAMERA SYSTEM MODEL ADS 1.5
K053044 · HKI
Opto Global, Inc.
Ophthalmic · 88d
Cleared Jan 24, 2006
PRIMO NONINVASIVE BLOOD PRESSURE MEASUREMENT SYSTEM
K053185 · DXN
Medwave, Inc.
Cardiovascular · 71d
Cleared Jan 24, 2006
NSK PRECISION APEX LOCATOR (PAL)
K053235 · LQY
Medicsense USA
Dental · 67d
Cleared Jan 24, 2006
ALTAIRE INTERVENTIONAL MR PACKAGE
K053309 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 57d
Cleared Jan 24, 2006
BE PLUS / AURA-LTM64 AMPLIFIER
K053606 · GWL
Eb Neuro S.P.A.
Neurology · 28d
Cleared Jan 24, 2006
IBA PROTON THERAPY SYSTEM-PROTEUS 235
K053641 · LHN
Ion Beam Applications S.A.
Radiology · 25d
Cleared Jan 24, 2006
PIONEER TC8080, COMPANION III
K053648 · IYN
Viasys Neuro Care
Radiology · 25d
Cleared Jan 24, 2006
ACCUVIX V7 DIAGNOSTIC ULTRASOUND SYSTEM
K060087 · IYN
Medison Co., Ltd.
Radiology · 12d
Cleared Jan 24, 2006
MODULAR TROCAR SYSTEM
K060096 · GCJ
Applied Medical Resources Corp.
General & Plastic Surgery · 11d
Cleared Jan 23, 2006
LIFESIGN DXPRESS, MODEL LSR2000
K050955 · JHI
Princeton BioMeditech Corp.
Chemistry · 283d
Cleared Jan 23, 2006
OPTIGEN ALLERGEN SPECIFIC IGE ASSAY
K051677 · DHB
Hitachi Chemical Diagnostics, Inc.
Immunology · 216d
Cleared Jan 23, 2006
CALCULASE HOLMIUM LASER SYSTEM AND ACCESSORIES
K052680 · GEX
KARL STORZ Endoscopy-America, Inc.
General & Plastic Surgery · 117d
Cleared Jan 23, 2006
LIBERTY BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-0067
K052762 · NBW
Agamatrix, Inc.
Chemistry · 115d
Cleared Jan 23, 2006
TRIAGE BNP TEST FOR BECKMAN COULTER IMMUNOASSAY SYSTEMS, MODEL 98200
K052789 · NBC
Biosite Incorporated
Chemistry · 112d
Cleared Jan 23, 2006
NT-1000
K052878 · GXD
Neuro Therm, Inc.
Neurology · 103d
Cleared Jan 23, 2006
ZIMMER DENTAL ONE-PIECE IMPLANT
K052997 · DZE
Zimmer Dental, Inc.
Dental · 90d
Cleared Jan 23, 2006
SYNTHES (USA) CHRONOS-BETA-TCP
K053022 · LYC
Synthes (Usa)
Dental · 89d
Cleared Jan 23, 2006
STAGE- 1 TEMPORARY/HEALING CAP, MODEL 42021-42026
K053643 · NHA
Lifecore Biomedical, Inc.
Dental · 24d
Cleared Jan 23, 2006
MEGABEAM SIDEFIBER FIBER OPTIC DELIVERY SYSTEM
K060050 · GEX
Biolitec, Inc.
General & Plastic Surgery · 17d
Cleared Jan 20, 2006
DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-ANEO5 AND L-ANEO5A SOFTWARE, USING...
K051400 · MHX
Ge Healthcare
Cardiovascular · 234d
Cleared Jan 20, 2006
MBCP
K051774 · MQV
Biomatlante
Orthopedic · 203d
Cleared Jan 20, 2006
DENTAL AIR-POWERED HANDPIECE, MODELS TIGER 100, 101, 200, 201 AND 202
K052822 · EFB
Thunder Tiger Corp.
Dental · 108d
Cleared Jan 20, 2006
VISULIZE FACTOR VIII ANTIGEN KIT, MODEL FVIII-AG
K052825 · GGP
Affinity Biologicals, Inc.
Hematology · 107d