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
115945–115968 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 22, 1992
MODEL P-81 CRITIKON PRINTER
K915468 · DXN
Critkon, Inc.
Cardiovascular · 292d
Cleared Sep 22, 1992
SHARPE ENDOSCALPEL
K920548 · HET
Paladin Medical, Inc.
Obstetrics & Gynecology · 229d
Cleared Sep 22, 1992
SHARPE ENDONEEDLE HOLDER
K920549 · HET
Paladin Medical, Inc.
Obstetrics & Gynecology · 229d
Cleared Sep 22, 1992
TEAM-MC II
K921828 · GZJ
Henley Intl.
Neurology · 159d
Cleared Sep 22, 1992
ENDOMED 582
K922020 · LIH
Henley Intl.
Neurology · 145d
Cleared Sep 22, 1992
ANASTOMART(TM) CORONARY BYPASS GRAFT MARKERS/MODIF
K922025 · DSY
Pioneering Technologies, Inc.
Cardiovascular · 168d
Cleared Sep 22, 1992
STERILE LATEX EXAMINATION GLOVES
K922379 · LYY
Smith & Nephew Perry
General Hospital · 125d
Cleared Sep 22, 1992
DALL MILES BROAD BONE PLATE
K922525 · HRS
Howmedica Corp.
Orthopedic · 117d
Cleared Sep 22, 1992
INSTRUMENTARIUM MEGA4 HT
K923022 · LNH
Instrumentarium Imaging, Inc.
Radiology · 91d
Cleared Sep 22, 1992
MILES SODIUM METHOD
K923037 · JOS
Heraeus Kulzer, Inc.
Chemistry · 95d
Cleared Sep 22, 1992
QBC HEMACAN HEMATOLOGY SYSTEM
K923121 · GKL
Bd Becton Dickinson Vacutainer...
Hematology · 88d
Cleared Sep 22, 1992
MICROBACT SOLID PLATE SYSTEMS
K923342 · JJS
Radiometer America, Inc.
Microbiology · 98d
Cleared Sep 22, 1992
AUTOSTAT ANTI-THYROGLOBULIN
K923370 · JNL
Cogent Diagnotics , Ltd.
Immunology · 75d
Cleared Sep 22, 1992
AUTOSTAT ANTI-THYROID MICROSSOMAL
K923371 · JNL
Cogent Diagnotics , Ltd.
Immunology · 75d
Cleared Sep 22, 1992
SYNERMED 600 NM URIC ACID REAGENT KIT
K923414 · KNK
Synermed, Inc.
Chemistry · 74d
Cleared Sep 22, 1992
HEMOCHRON/FACTOR VI FIBRINOGEN ASSAY AND CONT PLAS
K923593 · KQJ
International Technidyne Corp.
Hematology · 64d
Cleared Sep 22, 1992
SYSTEMATE PHOSPHORUS TEST TECHNICON RA 1000
K923764 · CEO
Em Diagnostic Systems, Inc.
Chemistry · 56d
Cleared Sep 22, 1992
SYSTEMATE URICACID TEST, TECHNICON RA 1000
K923765 · CDO
Em Diagnostic Systems, Inc.
Chemistry · 56d
Cleared Sep 22, 1992
MILES AUTO METH DETERMIN OF URIC ACID IN URINE
K924129 · KNK
Heraeus Kulzer, Inc.
Chemistry · 36d
Cleared Sep 21, 1992
TYPE INTERFACE 9271/1 INCUBATOR/WARMER
K912000 · FMZ
S & W Medico Teknik
General Hospital · 516d
Cleared Sep 21, 1992
ODYSSEY HO:YAG SURGICAL LASER SYSTEM
K914678 · GEX
Xintec Corporation
General & Plastic Surgery · 339d
Cleared Sep 21, 1992
UNISURGE DISPOSABLE TROCAR
K914923 · HET
Unisurge, Inc.
Obstetrics & Gynecology · 322d
Cleared Sep 21, 1992
CLAVE CONNECTOR
K915571 · FPA
Icu Medical, Inc.
General Hospital · 284d
Cleared Sep 21, 1992
PULMONARY ARTERY FLOW-DIRECTED THERMODILUTION CATH
K915726 · DQO
Baxter Healthcare Corp
Cardiovascular · 276d