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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
78121–78144 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jul 19, 2001
ENTEC EVAC PLASMA WAND
K011279 · GEI
Arthrocare Corp.
General & Plastic Surgery · 83d
Cleared Jul 19, 2001
INFINION ENHANCEMENT PACKAGE
K011296 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 80d
Cleared Jul 19, 2001
MTP LAPAROMAT DISPOSABLE TUBING SET
K011360 · GCJ
Mtp Medical Technical Promotion GmbH
General & Plastic Surgery · 77d
Cleared Jul 19, 2001
CAVEX STABISIL
K011452 · ELW
Cavex Holland BV
Dental · 69d
Cleared Jul 19, 2001
ENDOPOUCH RETRIEVER
K011501 · GCJ
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 64d
Cleared Jul 19, 2001
OHMEDA MEDICAL SPOT PT LITE PHOTOTHERAPY SYSTEM
K011549 · LBI
Ohmeda Medical
General Hospital · 62d
Cleared Jul 19, 2001
NEXGEN PRIMARY POROUS PATELLA, MODEL...
K011904 · JWH
Implex Corp.
Orthopedic · 30d
Cleared Jul 19, 2001
SYNTHES CERVIFIX SYSTEM
K011969 · KWP
Synthes (Usa)
Orthopedic · 24d
Cleared Jul 19, 2001
CASCADE BATH, MODEL 6900
K012057 · ILJ
Penner Manufacturing, Inc.
Physical Medicine · 17d