FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
147337–147360 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jul 29, 1985
PRIME AIRE O2 PLUS 2
K851437 · CAW
Invacare Corp.
Anesthesiology · 110d
Cleared Jul 29, 1985
MOBILAIRE II(P2A) OXYGEN CONCENTRATOR
K851438 · CAW
Invacare Corp.
Anesthesiology · 110d
Cleared Jul 29, 1985
MOBILAIRE, PLA-01 OXYGEN CONCENTRATOR
K851439 · CAW
Invacare Corp.
Anesthesiology · 110d
Cleared Jul 29, 1985
COLOR OVULATION TEST
K851445 · CEP
Nms Pharmaceuticals, Inc.
Chemistry · 109d
Cleared Jul 29, 1985
3.5. MHZ PROBE FOR AUSONICS 150 & 357 REAL TIME CA
K851616 · JOP
Ausonics Pty , Ltd.
Cardiovascular · 102d
Cleared Jul 29, 1985
MORTARA INSTRUMENT MODEL EL-1
K851702 · DSI
Mortara Instrument, Inc.
Cardiovascular · 96d
Cleared Jul 29, 1985
SOEHENDRA BILIARY DILATING CATHETER-SBDC-7
K851960 · FGE
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 87d
Cleared Jul 29, 1985
WILSON-COOK STONE EXTRACTOR
K851965 · FFL
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 87d
Cleared Jul 29, 1985
DENTIN ADHESIVE
K852024
Dentsply Intl.
Dental · 82d
Cleared Jul 29, 1985
QUIDEL QUEST OVULATION TEST
K852146 · CEP
Quidel Corp.
Chemistry · 74d
Cleared Jul 29, 1985
329 CORDIS ENCOR PREVENOUS ARTRIAL & VENTRICULAR
K852253 · DTD
Cordis Corp.
Cardiovascular · 66d
Cleared Jul 29, 1985
WHOLEY HI-TORQUE GUIDE WIRES
K852354 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 56d
Cleared Jul 29, 1985
EXTRA LARGE ADHESIVE STRIPS
K852408 · KGX
American White Cross, Inc.
General & Plastic Surgery · 53d
Cleared Jul 29, 1985
NON-ADHERENT PAD
K852412 · EFQ
American White Cross, Inc.
General & Plastic Surgery · 53d