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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
147913–147936 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 30, 1985
DIAMAT GLYCOSLATED HEMOGLOBIN ANALYZER SYSTEM
K851636 · LCP
Bio-Rad
Hematology · 102d
Cleared Jul 30, 1985
COULTER CHANNELYZER 256
K851736 · GKL
Coulter Electronics, Inc.
Hematology · 96d
Cleared Jul 30, 1985
OSMOCEL 3
K851843 · GIF
Hematology Marketing Assoc.
Hematology · 95d
Cleared Jul 30, 1985
SYSTEM 1085 BODY PLETHYSMOGRAPH
K852088 · CCM
Medical Graphics Corp.
Anesthesiology · 78d
Cleared Jul 30, 1985
PB900 PB910 DIAGNOSTIC SPIROMETER
K852092 · BZG
Puritan Bennett Corp.
Anesthesiology · 77d
Cleared Jul 30, 1985
PATHFINDER DETECTION & COLLECTION KITS-HERPES SIMP
K852125 · GQL
Kallestad Laboratories, Inc.
Microbiology · 76d
Cleared Jul 30, 1985
POROCOAT SCHATZKER II ACETABULUM
K852193 · DXQ
Depuy, Inc.
Cardiovascular · 71d
Cleared Jul 30, 1985
LIFESCOPE 8 DEC-8108A AND DEC-8204A
K852270 · DSI
Nihon Kohden America, Inc.
Cardiovascular · 63d
Cleared Jul 30, 1985
THERMIX INC. NASOTHERM II PERSONAL STEAM MACHINE
K852283 · KFZ
Thermix, Inc.
Anesthesiology · 62d
Cleared Jul 30, 1985
KELLY-GROERSS-KALL CT STEROTACTIC ADAPTATION SYS
K852477 · HAW
Mayo Clinic
Neurology · 49d
Cleared Jul 30, 1985
CROMIC SURGICAL MICROSCOPE MODEL MC-1
K852586 · HRM
Seltrex, Corp.
General & Plastic Surgery · 42d
Cleared Jul 30, 1985
BIOGLOSS
K852659 · EBF
Dentsply Intl.
Dental · 36d
Cleared Jul 30, 1985
QUIDEL QUEST STREP GROUP A TEST
K852806 · GTZ
Quidel Corp.
Immunology · 27d
Cleared Jul 30, 1985
PENNINE CONNECTING TUBING
K852859
Pennine Medical , Ltd.
General & Plastic Surgery · 25d
Cleared Jul 30, 1985
BACTEC NR-730 BACTERIAL DETECTION SYSTEM
K853011 · JTA
Bd Becton Dickinson Vacutainer...
Microbiology · 14d
Cleared Jul 29, 1985
SECHRIST VOLUME VENTILATOR MODIFICATION
K850740
Sechrist Industries, Inc.
Cardiovascular · 182d
Cleared Jul 29, 1985
RINSE MACHINE KR-4 KIDNEY RINSE-4
K850799 · LIF
Medical Technologies International, Inc.
Gastroenterology & Urology · 152d
Cleared Jul 29, 1985
HEMOCONCENTRATOR KIT
K850979 · KDI
Omnis Surgical, Inc.
Gastroenterology & Urology · 143d
Cleared Jul 29, 1985
ARTERIAL FILTER AFS-XX /FILTER HOLDER AFS-HXX
K851003 · DTM
Gish Biomedical, Inc.
Cardiovascular · 139d
Cleared Jul 29, 1985
VAN-TEC GUIDE WIRE W/HYDROMER COATING
K851160 · KOD
Van-Tec, Inc.
Gastroenterology & Urology · 129d
Cleared Jul 29, 1985
THERMOPHORE ELECTRIC FOMENTATION UNIT
K851237 · IRT
Battle Creek Equipment Co.
Physical Medicine · 124d
Cleared Jul 29, 1985
DOPLETTE 10
K851269 · JOP
Imex Medical Systems, Inc.
Cardiovascular · 187d
Cleared Jul 29, 1985
MOBILAIRE III P3 OXYGEN CONCENTRATOR
K851434 · CAW
Invacare Corp.
Anesthesiology · 110d
Cleared Jul 29, 1985
PRIME AIRE O, MODEL PA02 2 O OXYGEN CONCENTRATOR
K851435 · CAW
Invacare Corp.
Anesthesiology · 110d