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
78961–78984 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 01, 2001
AGILENT INFORMATION CENTER SOFTWARE FOR M3150,M3151,M3153 AND M3154
K011093 · MHX
Agilent Technologies, Inc.
Cardiovascular · 21d
Cleared May 01, 2001
ABBOTT ACCLAIM ENCORE, MODEL 12237
K011096 · FRN
Abbott Laboratories
General Hospital · 21d
Cleared Apr 30, 2001
COBE HC 700 MIDI HEMOCONCENTRATOR
K003023 · KDI
Hospal Industrie
Gastroenterology & Urology · 214d
Cleared Apr 30, 2001
VACUETTE SPEEDY QUICK-RELEASE HOLDER
K003812 · FMI
Greiner Vacuette North America, Inc.
General Hospital · 140d
Cleared Apr 30, 2001
TOTAL PTH IMMUNORADIOMETRIC ASSAY(IRMA) DIAGNOSTIC KIT, MODEL 3KG600
K004038 · CEW
Scantibodies Laboratory, Inc.
Chemistry · 123d
Cleared Apr 30, 2001
ORTHO CONTROL FEMALE URINARY CONTROL DEVICE
K010365 · MNG
Personal Products Co.
Gastroenterology & Urology · 82d
Cleared Apr 30, 2001
APPLICATOR TIP/DUAL SPRAYER KIT
K010708 · FMF
Interpore Cross Intl.
General Hospital · 52d
Cleared Apr 30, 2001
POSI-GRIP UMBILICAL CORD CLAMP, STERILE, MODEL 384, POSI-GRIP UMBILICAL CORD...
K010835 · HFW
Busse Hospital Disposables, Inc.
Obstetrics & Gynecology · 41d
Cleared Apr 30, 2001
SIMPLICITY WING INFUSION SET
K010886 · FPA
Sterling Medivations, Inc.
General Hospital · 38d
Cleared Apr 30, 2001
ALIEN RX MICRO CANNULA, MODEL 4530
K010993 · ODD
Boston Scientific Corp
Gastroenterology & Urology · 27d
Cleared Apr 27, 2001
SENOJ IMPLANT SYSTEM
K000889 · DZE
Senoj Biocare, Inc.
Dental · 403d
Cleared Apr 27, 2001
GRAFT MARKER RING
K001915 · MAB
T. Korossurgical Instruments Corp.
Cardiovascular · 308d
Cleared Apr 27, 2001
KSI'S NEW CAMERA ARCHITECTURE (NCA) VIDEO IMAGING SYSTEM
K003325 · FET
Karl Storz Imaging, Inc.
Gastroenterology & Urology · 185d
Cleared Apr 27, 2001
MIASPAS MINITTA ANTERIOR MICRO SURGICAL TRANSTHORACIC APPROACH INSTRUMENTATION
K003740 · HRX
Aesculap, Inc.
Orthopedic · 144d
Cleared Apr 27, 2001
SPERMICIDAL LUBRICATED MALE LATEX CONDOM
K010178 · LTZ
Innolatex Sdn. Bhd
Obstetrics & Gynecology · 98d
Cleared Apr 27, 2001
HANSATOME MICROKERATOME
K010260 · HNO
Bausch & Lomb, Inc.
Ophthalmic · 88d
Cleared Apr 27, 2001
NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTORS AND...
K010264 · FIB
Nipro Medical Corp.
Gastroenterology & Urology · 88d
Cleared Apr 27, 2001
FRESENIUS PRIMING SET WITH NEEDLES ACCESS PORT, MODEL 04-9002-9
K010268 · KOC
Fresenius Medical Care North America
Gastroenterology & Urology · 88d
Cleared Apr 27, 2001
DRYSTAR 4500 PRINTER, MODEL 4500
K010275 · LMC
Agfa Medical Imaging
Radiology · 87d
Cleared Apr 27, 2001
MED-LOGICS DISPOSABLE ALK TUBING
K010353 · KYG
Med-Logics, Inc.
Ophthalmic · 80d
Cleared Apr 27, 2001
LIFESTYLES, CONTEMPO OR PRIVATE LABEL, MALE LATEX CONDOM WITH GLYCERINE...
K010371 · HIS
Suretex, Ltd.
Obstetrics & Gynecology · 79d
Cleared Apr 27, 2001
CEDARS-SINAI BPGS AND MOCO
K010509 · KPS
Smv America
Radiology · 65d
Cleared Apr 27, 2001
TITANIUM CEMENT RESTRICTOR MATERIAL PLDLA
K010529 · JDI
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 63d
Cleared Apr 27, 2001
MODIFICATION TO TISSUELINK MONOPOLAR FLOATING BALL
K010662 · GEI
Tissuelink Medical, Inc.
General & Plastic Surgery · 57d