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
76681–76704 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 04, 2002
BIOSUC
K013108 · KNW
Hakko Medical Co., Ltd.
Gastroenterology & Urology · 199d
Cleared Apr 04, 2002
TRUWAVE
K013210 · GZJ
Dan Med, Inc.
Neurology · 190d
Cleared Apr 04, 2002
RESECTION ABLATOR
K013369 · GEI
Linvatec Corp.
General & Plastic Surgery · 175d
Cleared Apr 04, 2002
MAYFIELD/ACCISS OPERATING ARM SYSTEM AND MAYFIELD/OPTICAL ACCISS SYSTEM
K013428 · HAW
Ohio Medical Instrument Co., Inc.
Neurology · 170d
Cleared Apr 04, 2002
ORTHOPILOT 2
K013569 · HAW
Aesculap, Inc.
Neurology · 157d
Cleared Apr 04, 2002
MILLEX GP STERILIZING FILTER UNIT, MODEL SLGP 033 R
K013988 · BSN
Millipore Corp.
Anesthesiology · 121d
Cleared Apr 04, 2002
MEDICAL LE
K020058 · LLZ
Barco N.V.
Radiology · 86d
Cleared Apr 04, 2002
GYRUS ENT SOMNOPLASTY GENERATOR
K020067 · GEI
Gyrus Ent LLC
General & Plastic Surgery · 85d
Cleared Apr 04, 2002
VT-1
K020154 · LKY
Pos-T-Vac, Inc.
Gastroenterology & Urology · 77d
Cleared Apr 04, 2002
SUPPORT SLEEVE
K020258 · LKY
Pos-T-Vac, Inc.
Gastroenterology & Urology · 69d
Cleared Apr 04, 2002
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM
K020323 · LON
Becton, Dickinson & CO
Microbiology · 79d
Cleared Apr 04, 2002
CAL-CHEX CD PLUS
K020469 · KRX
Streck Laboratories, Inc.
Hematology · 51d
Cleared Apr 04, 2002
LONG LENGTH GAMMA NAIL
K020773 · HSB
Howmedica Osteonics Corp.
Orthopedic · 27d
Cleared Apr 04, 2002
GE VIVID 3 EXPERT
K020789 · IYN
General Electric Co.
Radiology · 24d
Cleared Apr 04, 2002
GARAVENTA SUPER-TRAC TRE-52
K020933 · ING
Garaventa Accessibility
Physical Medicine · 13d
Cleared Apr 04, 2002
ADPER PROMPT
K020946 · KLE
3M Espe AG Dental Products
Dental · 10d
Cleared Apr 04, 2002
APOLLO, MODEL 1124525
K020949 · EJT
Sterngold
Dental · 10d
Cleared Apr 04, 2002
MODIFICATION TO ONCOLOGY SALVAGE SYSTEM (OSS)
K020970 · JDI
Biomet, Inc.
Orthopedic · 9d
Cleared Apr 04, 2002
PAIN CARE 4200
K020988 · MEB
Breg, Inc.
General Hospital · 8d
Cleared Apr 04, 2002
APEX PH.I.S.I.O. ADULT HOLLOW FIBER MEMBRANE OXYGENATOR
K020997 · DTZ
Dideco S.P.A.
Cardiovascular · 7d
Cleared Apr 04, 2002
SARNS CENTRIFUGAL PUMP WITH XCOATING, MODEL 164275X
K020998 · KFM
Terumo Cardiovascular Systems Corp.
Cardiovascular · 7d
Cleared Apr 03, 2002
SAFE-STEER GUIDE WIRE SYSTEM
K011986 · DQX
Intra Luminal Therapeutics, Inc.
Cardiovascular · 281d
Cleared Apr 03, 2002
SAFE AT HOME CHOLESTEROL PROFILE BLOOD COLLECTION AND TRANSPORT SYSTEM
K012221 · JKA
Biosafe Laboratories, Inc.
Chemistry · 261d
Cleared Apr 03, 2002
2 PIECE MODULAR HIP STEM
K013106 · LZO
Howmedica Osteonics Corp.
Orthopedic · 198d