FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
123433–123456 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 25, 1991
FEEL FRESH TOOTHBRUSH KIT
K905090 · EFW
Fresh Appeal , Ltd.
Dental · 72d
Cleared Jan 25, 1991
DIGITAL DISK RECORDER(DDR) W/NUMERICAL SUFFIXES
K905111 · JAA
Eigen
Radiology · 73d
Cleared Jan 25, 1991
MULTIPLE IMAGING XENON ARC AUTO LIGH SOURCE
K905124 · GCT
Red Wing Imaging, Inc.
Gastroenterology & Urology · 72d
Cleared Jan 25, 1991
VANCOMYCIN DISK-5 MCG
K905151 · JTO
Remel Co.
Microbiology · 71d
Cleared Jan 25, 1991
NEUROMED MODEL 1992 LS LAMITRODE LEAD
K905255 · GZB
Neuromed, Inc.
Neurology · 65d
Cleared Jan 25, 1991
ADSON-BECKMAN RETRACTOR, SPINAL
K905445 · GZT
A. Henniss
Neurology · 52d
Cleared Jan 25, 1991
IMMUNOWELL THYROGLOBULIN TEST
K905485 · JZO
General Biometrics, Inc.
Immunology · 50d
Cleared Jan 25, 1991
LUPUS(LE)-LATEX TEST
K905531 · LKI
Immco Diagnostics, Inc.
Immunology · 46d
Cleared Jan 25, 1991
COLUMNS LIQUID CHROMATOGRAPHY DPM
K905538 · KZR
Millpore Corp.
Chemistry · 45d
Cleared Jan 25, 1991
SYSTEMATE ALBUMIN (EPOS APPLICATION) #65401
K905660 · CIX
Em Diagnostic Systems, Inc.
Chemistry · 38d
Cleared Jan 25, 1991
AIA-PACK HGH
K905757 · CFL
Tosoh Medics, Inc.
Chemistry · 29d
Cleared Jan 25, 1991
COULTER DART ALT (GPT) REAGENT
K905767 · CKA
Coulter Electronics, Inc.
Chemistry · 29d
Cleared Jan 25, 1991
UBI MAGIWEL(TM) ANA QUANTITATIVE
K910033 · LJM
United Biotech, Inc.
Immunology · 21d
Cleared Jan 24, 1991
EUB-565 DIAGNOSTIC ULTRASOUND DEVICE
K896100 · IYO
Hitachi Medical Corp. of America
Radiology · 461d
Cleared Jan 24, 1991
E. COLI 0157 LATEX TEST
K903714 · GNA
Pro-Lab, Inc.
Microbiology · 163d
Cleared Jan 24, 1991
DENSICOMP 250
K904587 · KPW
L. Keroack Co.
Radiology · 107d
Cleared Jan 24, 1991
ENDOPATH DISPOSABLE SURGICAL TROCAR REDUCER
K904907 · HET
Ethicon, Inc.
Obstetrics & Gynecology · 85d
Cleared Jan 24, 1991
LIATEST(R) AT III TEST KIT
K905110 · JBQ
American Bioproducts Co.
Hematology · 72d
Cleared Jan 24, 1991
VISTA HPQ SYSTEM
K905259 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 62d
Cleared Jan 24, 1991
SLIM LINE RETENTION TIP W/ SILICONE RUBBER CUFF
K905574 · FGD
E-Z-Em, Inc.
Gastroenterology & Urology · 43d
Cleared Jan 24, 1991
HYPOALLERGENIC LATEX EXAMINATION GLOVES
K910009 · LYY
Straitscom
General Hospital · 22d
Cleared Jan 24, 1991
PARK CITY SHOULDER POSITIONER
K910031 · FWZ
Orthopedic Systems, Inc.
General & Plastic Surgery · 20d
Cleared Jan 23, 1991
CAPNOMAC ULTIMA (TM) ANESTHESIA MONITOR
K903104 · CBQ
Datex Division Instrumentarium Corp.
Anesthesiology · 194d
Cleared Jan 23, 1991
BML SERIES
K903529 · LQC
Olympus Corp.
Gastroenterology & Urology · 170d