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
115009–115032 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 21, 1992
CALCIUM CHLORIDE/DIETHYLBARB ACETATE BUFF SOLUTION
K924509 · JPA
Behring Diagnostics, Inc.
Hematology · 108d
Cleared Dec 21, 1992
GDC 3445
K925273 · EJS
Deringer-Ney, Inc.
Dental · 63d
Cleared Dec 21, 1992
RT2 RIGIDITY AND TUMESCENCE TEST
K925931 · LIL
Compass Medical Technologies, Inc.
Gastroenterology & Urology · 28d
Cleared Dec 18, 1992
BSM-8800A BEDSIDE MONITOR
K920154 · DSI
Nihon Kohden America, Inc.
Cardiovascular · 340d
Cleared Dec 18, 1992
RMI EXTERNAL CORONARY ARTERY OCCLUDER
K920936 · DXC
Research Medical, Inc.
Cardiovascular · 294d
Cleared Dec 18, 1992
STYLET AND TRACHEAL LIGHTWAND (STL)
K922842 · BSR
Laerdal California, Inc.
Anesthesiology · 189d
Cleared Dec 18, 1992
MAGNETIC RESONANCE DIAG DEVICE ACCESS APPLIC PKG
K924426 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 108d
Cleared Dec 18, 1992
MULTI-CHANNEL DISCRETE ANALYZER (MDA-180)
K924453 · JPA
Organon Teknika Corp.
Hematology · 107d
Cleared Dec 18, 1992
OLYMPUS IRON REAGENT
K924691 · JIY
Olympus Corp.
Chemistry · 92d
Cleared Dec 18, 1992
SCALE SET SOLUTIONS/405NM CAT#1480-650NM CAT#1479
K924915 · JJY
Helena Laboratories
Hematology · 80d
Cleared Dec 17, 1992
CRS RADIATION BEAM SCANNER
K914821 · IYI
Consolidated Radiation Services, Inc.
Radiology · 419d
Cleared Dec 17, 1992
FIRSTTEMP GENIUS
K920713 · FLL
Intelligent Medical Systems
General Hospital · 303d
Cleared Dec 17, 1992
ALVINE TOTAL ANKLE
K920802 · HSN
Depuy, Inc.
Orthopedic · 300d
Cleared Dec 17, 1992
SOLUTION ADMINISTRATION SET
K921429 · FPA
Sierra Medical Devices
General Hospital · 268d
Cleared Dec 17, 1992
ES 1500 ECG DEMODULATOR
K921699 · DXH
Epic Systems, Inc.
Cardiovascular · 253d
Cleared Dec 17, 1992
VENTILATOR INTERFACE 9291/4
K922314 · CBK
S & W Medico Teknik
Anesthesiology · 213d
Cleared Dec 17, 1992
6 FRENCH CATHETER
K922564 · JAQ
S. and H. Engineering, Inc.
Radiology · 199d
Cleared Dec 17, 1992
BATTERY PACKS
K923305 · CCK
Access / God Loves You
Anesthesiology · 182d
Cleared Dec 17, 1992
STERILE DYNA LOK ANTERIOR PLATING SYSTEM
K923446 · KWQ
Sofamor Danek Mfg., Inc.
Orthopedic · 156d
Cleared Dec 17, 1992
POLYDOROS XS50 AND SX80
K923786 · IZO
Siemens Medical Solutions USA, Inc.
Radiology · 142d
Cleared Dec 17, 1992
CENTURION DISPOSABLE INSTRUMENTS
K923812 · MDM
Tri-State Hospital Supply Corp.
General & Plastic Surgery · 141d
Cleared Dec 17, 1992
FUJI COMPUTED RADIOGRAPHY HI-C652B DMS CRT IMAGE
K923990 · IXK
Fujifilm Medical System U.S.A., Inc.
Radiology · 129d
Cleared Dec 17, 1992
BECTON DICKINSON SAFETY-LOK SYRINGE
K924072 · FMF
Bd Becton Dickinson Vacutainer...
General Hospital · 127d
Cleared Dec 17, 1992
RECONSTRUCTION PLATE SYSTEM
K924085 · HRS
Sofamor Danek Mfg., Inc.
Orthopedic · 126d