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
117169–117192 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 15, 1992
GIANTURCO-ROSCH BILIARY Z STENT
K921191 · FGE
Cook, Inc.
Gastroenterology & Urology · 78d
Cleared May 15, 1992
EURION LOTOS P HEARING AID
K921257 · ESD
Manro Corp.
Ear, Nose, Throat · 60d
Cleared May 15, 1992
DELUXE C ARM RADIOLOGICAL TABLE, MODEL #056-004
K921501 · IZZ
Biodan Medical Systems, Ltd.
Radiology · 45d
Cleared May 14, 1992
SIMON BREAST LESION LOCALIZATION NEEDLE
K914941 · GDF
Manan Medical Products, Inc.
General & Plastic Surgery · 192d
Cleared May 14, 1992
K-DEFIB/PACE ELECTRODE
K914955 · DRO
Katecho, Inc.
Cardiovascular · 191d
Cleared May 14, 1992
DISPOSABLE SKIN MARKER
K915066 · FZZ
American Medical Mfg., Inc.
General & Plastic Surgery · 188d
Cleared May 14, 1992
LO-PROFILE EXTENSION SET
K915560 · FPK
Douglas Medical Products Corp.
General Hospital · 155d
Cleared May 14, 1992
PBI MULTILASE D COPPER VAPOR LASER
K920004 · GEX
Wm.I.Kern & Co., Inc.
General & Plastic Surgery · 133d
Cleared May 14, 1992
SUPERGLOVES
K920058 · LYY
Sempermed Glove Industries Sdn Bhd
General Hospital · 129d
Cleared May 14, 1992
POSEY SITTER
K920206 · KMI
J. T. Posey Co.
General Hospital · 119d
Cleared May 14, 1992
N-TACT(R) PTH SP KIT
K921629 · CEW
Incstar Corp.
Chemistry · 38d
Cleared May 13, 1992
BASKET LITTER CARRIER
K915874 · FPP
Bradco Med , Ltd.
General Hospital · 156d
Cleared May 13, 1992
UNI-DOSE SYRINGE PUMP
K920013 · FRN
Electrochemical Drug Delivery, Inc.
General Hospital · 132d
Cleared May 13, 1992
SOLUMBRA SUN PROTECTIVE CLOTHING
K920240 · MIW
Wetmore Assoc., Inc.
General & Plastic Surgery · 117d
Cleared May 13, 1992
FAIRBANKS BABY SCALE
K920812 · FRW
Fairbanks Scales, Inc.
General Hospital · 82d
Cleared May 13, 1992
SYVA EMIT II METHAQUALONE ASSAY
K921013 · KXS
Syva Co.
Toxicology · 71d
Cleared May 13, 1992
SHARPLAN C02 ULTRASWIFT VAPORIZATION ENDPIECE
K921596 · GEX
Sharplan Lasers, Inc.
General & Plastic Surgery · 40d
Cleared May 13, 1992
CALCIUM-ARSENAZO III REAGENT SET
K921625 · CIC
Pointe Scientific, Inc.,
Chemistry · 37d
Cleared May 13, 1992
NEXTEC FIBEROPTIC ILLUMINATOR 300 WATT XENON
K921646 · FST
Nextec Corp.
General & Plastic Surgery · 37d
Cleared May 12, 1992
ALPHA-STIM CS
K903014 · QJQ
Electromedical Products, Inc.
Neurology · 672d
Cleared May 12, 1992
LB-2000 CRANIAL ELECTROTHERAPY STIMULATOR
K910616 · QJQ
Life Balance Intl., Inc.
Neurology · 455d
Cleared May 12, 1992
TSRH CENTRAL POST HOOKS
K914966 · KWP
Sofamor Danek Mfg., Inc.
Orthopedic · 189d
Cleared May 11, 1992
THE BELTONE AUDIO SCOUT
K915323 · EWO
Beltone Electronics Corp.
Ear, Nose, Throat · 171d
Cleared May 11, 1992
DADE IMMUNOADSORBED FACTOR IX DEFICIENT PLASMA
K915411 · GJT
Baxter Diagnostics, Inc.
Hematology · 161d