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
78625–78648 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 20, 2001
ARTHROSCOPES
K003831 · HRX
Global Endoscopy, Inc.
Orthopedic · 221d
Cleared Jul 20, 2001
BIOCHECK HIGH SENSITIVITY C-REACTIVE PROTEIN ENZYME IMMUNOASSAY TEST KIT,...
K003851 · DCK
Biocheck, Inc.
Chemistry · 220d
Cleared Jul 20, 2001
MACROPORE OS SPINAL SYSTEM
K010911 · KWQ
Macropore Biosurgery, Inc.
Orthopedic · 116d
Cleared Jul 20, 2001
NORMED EXTREMITY TITANIUM HAND AND SMALL FRAGMENT SYSTEM
K011118 · HRS
Osteomedics
Orthopedic · 99d
Cleared Jul 20, 2001
SYSMEX AUTOMATED COAGULATION ANALYZER / MODEL # CA-1500
K011235 · JPA
Dade Behring, Inc.
Hematology · 88d
Cleared Jul 20, 2001
FLAVORED MALE LATEX CONDOM
K011253 · HIS
Thai Nippon Rubber Industry Co., Ltd.
Obstetrics & Gynecology · 87d
Cleared Jul 20, 2001
NIEN MADE NON-INVASIVE BLOOD PRESSURE MONITOR, MODELS HP-BPM0001
K011310 · DXN
Nien Made Electrnics Corp.
Cardiovascular · 81d
Cleared Jul 20, 2001
STRYKER TITANIUM CROSS-SCREW SYSTEM, MODEL 234-500-1XX
K011319 · JDW
Stryker Endoscopy
Orthopedic · 80d
Cleared Jul 20, 2001
CARDIONAVIGATOR INFORMATION MANAGEMENT SYSTEM
K011345 · DXH
Reynolds Medical , Ltd.
Cardiovascular · 79d
Cleared Jul 20, 2001
ROSSMAX SMARTINFLATE CARDIOPRO, MODEL 1000I AND MODEL 3000I BLOOD PRESSURE...
K011352 · DXN
Rossmax International , Ltd.
Cardiovascular · 78d
Cleared Jul 20, 2001
ROSSMAX MEDIPRO MODEL 100, MODEL 200, AND MODEL 300 BLOOD PRESSURE MONITORS
K011539 · DXN
Rossmax International , Ltd.
Cardiovascular · 63d
Cleared Jul 20, 2001
ALKALINE PHOSPHATASE LIQUID REAGENT
K011599 · CJE
Jas Diagnostics, Inc.
Chemistry · 57d
Cleared Jul 20, 2001
FADASIS MEDICAL FM-1 NO BLENDER
K011874 · MRO
Fadasis Medical, Inc.
Anesthesiology · 35d
Cleared Jul 20, 2001
INFINITY SC 8000 WITH ADVANCED COMMUNICATION OPTION II
K012016 · MHX
Siemens Medical Solutions USA, Inc.
Cardiovascular · 22d
Cleared Jul 20, 2001
COLOR BUFFED (CB) DDH FEMORAL STEM
K012019 · JDI
Biomet, Inc.
Orthopedic · 22d
Cleared Jul 20, 2001
MODIFICATION TO XIA SPINE SYSTEM
K012027 · MNH
Howmedica Osteonics
Orthopedic · 22d
Cleared Jul 20, 2001
MODIFICATION TO DEVICE LINK SYSTEM, MODEL M2376A
K012094 · MWI
Agilent Technologies, Inc.
Cardiovascular · 15d
Cleared Jul 20, 2001
LIVESURE PHENECYCLINE (PCP) SCREEN TESTS
K012107 · LCM
Pan Probe Biotech, Inc.
Toxicology · 15d
Cleared Jul 20, 2001
LIVESURE BENZODIAZEPINES SCREEN TESTS
K012131 · JXM
Pan Probe Biotech, Inc.
Toxicology · 11d
Cleared Jul 20, 2001
LIVESURE BARBITURATES SCREEN TEST
K012133 · DIS
Pan Probe Biotech, Inc.
Toxicology · 11d
Cleared Jul 20, 2001
BLOOD PRESSURE MONITOR (SPHYGMOMANOMETER), MODEL HT-110
K012194 · DXQ
Nihon Seimitsu Sokki Co., Ltd.
Cardiovascular · 7d
Cleared Jul 20, 2001
NORTHEAST PROTON THERAPY CENTER
K983332 · LHN
Massachusetts General Hospital
Radiology · 1032d
Cleared Jul 19, 2001
PRO OSTEON 200R WITH CALCIUM SULFATE, MODELS 2RCS038, 2RCS050, 2RCS075,...
K004003 · MQV
Interpore Cross Intl.
Orthopedic · 206d
Cleared Jul 19, 2001
SPLITTABLE SHEATH INTRODUCER KIT
K004025 · DYB
Thomas Medical Products, Inc.
Cardiovascular · 204d