FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
82633–82656 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 05, 2000
MODIFICATION TO CARTO EP NAVIGATION SYSTEM
K000190 · DQK
Biosense Webster, Inc.
Cardiovascular · 113d
Cleared May 05, 2000
CARTO EP NAVIGATION SYSTEM
K000248 · DQK
Biosense Webster, Inc.
Cardiovascular · 99d
Cleared May 05, 2000
POLYGRAM 98 ANORECTAL FUNCTION TESTING APPLICATION, MODEL 9043S0111
K000386 · FFX
Medtronic Functional Diagnostics A/S
Gastroenterology & Urology · 88d
Cleared May 05, 2000
YOSHIDA WAVE PICT CAM INTRAORAL CAMERA, SIGMA BIOMEDICS SIGMACAM INTRAORAL...
K000577 · EIA
The Yoshida Dental Mfg. Co., Ltd.
Dental · 73d
Cleared May 05, 2000
SERIM LEUKOCYTE ESTERASE TEST STRIPS
K000578 · LJX
Serim Research Corp.
Hematology · 73d
Cleared May 05, 2000
SYNCHRON SYSTEMS AMPHETAMINE REAGENT
K000606 · DKZ
Beckman Coulter, Inc.
Toxicology · 72d
Cleared May 05, 2000
PIONEER SURGICAL TECHNOLOGY EXTENDED GTR, MODEL 501-601
K000734 · KTT
Pioneer Surgical Technology
Orthopedic · 59d
Cleared May 05, 2000
CALIBRITE PERCP-CY5.5 BEADS AND FACSCOMP SOFTWARE
K000897 · GKZ
Bd Biosciences
Hematology · 45d
Cleared May 05, 2000
BIOZ.COM HEMODYNAMIC MONITOR WITH BIOZ TECT SENSOR AND BIOZ TECT CABLE...
K001100 · DSB
Cardiodynamics International Corp.
Cardiovascular · 30d
Cleared May 05, 2000
ULTRAEDGE KERATOME BLADE, MODEL 374803 - ACS
K001144 · HNO
Lasersight Technologies, Inc.
Ophthalmic · 25d
Cleared May 05, 2000
SHARPLAN LASERS, INC. PULSED CTH:YAG HOLMIUM SURGICAL LASER, MODEL 2040
K001263 · GEX
E S C Sharplan
General & Plastic Surgery · 16d
Cleared May 05, 2000
MODIFICATION TO MIXJECT DISPENSING PIN/WITH DETACHABLE VIAL HOLDER/WITH...
K001293 · LHI
Medimop Medical Projects, Ltd.
General Hospital · 11d
Cleared May 05, 2000
VITROS CHEMISTRY PRODUCTS CREA SLIDE, VIRTROS CHEMISTRY PRODUCTS CALIBRATOR...
K001310 · JFY
Ortho-Clinical Diagnostics, Inc.
Chemistry · 10d
Cleared May 05, 2000
EPSTIM ELECTROPHYSIOLOGY STIMULATOR CONTROL PROGRAM, BLOOM DTU-215...
K991293 · JOQ
Fischer Medical Technologies, Inc.
Cardiovascular · 386d
Cleared May 05, 2000
BINDAZYME ANTI-B2 GP1 IGG EIA TEST KIT
K991801 · MSV
The Binding Site, Ltd.
Immunology · 345d
Cleared May 05, 2000
BINDAZYME ANTI-B2 GP1 IGA EIA TEST KIT
K991802 · MSV
The Binding Site, Ltd.
Immunology · 345d
Cleared May 05, 2000
BINDAZYME ANTI B2 GP1 IGM EIA TEST KIT.
K991803 · MSV
The Binding Site, Ltd.
Immunology · 345d
Cleared May 05, 2000
BINDAZYME ANTI-B2 SCREEN EIA TEST KIT.
K991804 · MSV
The Binding Site, Ltd.
Immunology · 345d
Cleared May 05, 2000
THROMBELASTOGRAPH COAGULATION ANALYZER TEG - 5000 SERIES
K993678 · JPA
Haemoscope Corp.
Hematology · 186d
Cleared May 05, 2000
DIRECTFLOW KIT, 24 FR, SOFTCLAMP KIT, 24FR, STRAIGHTSHOT KIT, 23 FR, STRAIGHT...
K994243 · DWF
Heartport, Inc.
Cardiovascular · 141d
Cleared May 05, 2000
CONNECT DATA MANAGEMENT SYSTEM
K994433 · LFR
Abbott Diabetes Care, Inc.
Chemistry · 127d
Cleared May 04, 2000
NOGA CARDIAC NAVIGATION SYSTEM
K000332 · DQK
Biosense Webster, Inc.
Cardiovascular · 91d
Cleared May 04, 2000
EYECAP IMAGING SYSTEM
K000368 · HKI
Clement Clarke Intl., Ltd.
Ophthalmic · 90d
Cleared May 04, 2000
SHUTTLE STOP
K000587 · LZN
Isotis NV
Orthopedic · 72d