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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
124033–124056 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 10, 1990
F-19 TOTAL HIP PROSTHESIS
K903234 · JDI
Med-Tek Corp.
Orthopedic · 79d
Cleared Oct 10, 1990
COOK-GIANTURCO ROSCH BILIARY Z-STENT, MODIFICATION
K903858 · FGE
Cook, Inc.
Gastroenterology & Urology · 51d
Cleared Oct 10, 1990
STAGE IV, AIR-FLUIDIZE BED
K904008 · INX
Unique Flotation Systems, Inc.
Physical Medicine · 42d
Cleared Oct 10, 1990
INFLAT-O-BALL
K904026 · HHW
Milex Products, Inc.
Obstetrics & Gynecology · 41d
Cleared Oct 10, 1990
CHEMO GLOVES POWDER FREE (MFG: UNION INDUSTRIAL)
K904130 · LYY
Biosafety Systems, Inc.
General Hospital · 35d
Cleared Oct 09, 1990
M(3):MICRO MUSCLE MONITOR
K896409 · HCC
Thought Technology , Ltd.
Neurology · 336d
Cleared Oct 09, 1990
NEUSTEIN LARYNGOSCOPE
K901164 · CCW
Neutech Corp.
Anesthesiology · 211d
Cleared Oct 09, 1990
GREENFIELD VENA CAVA FILTER W/19.5 FR INTRODUCER
K901235 · DTK
Boston Scientific Corp
Cardiovascular · 209d
Cleared Oct 09, 1990
WILSON-COOK BRONCHOSCOPE BIOPSY FORCEPS
K901348 · EGQ
Wilson-Cook Medical, Inc.
Dental · 200d
Cleared Oct 09, 1990
THAYER METERED DOSE INHALER DISPENSER/ADAPTER
K901739 · CAI
Thayer Medical Corp.
Anesthesiology · 176d
Cleared Oct 09, 1990
RTM 36-05, 60-05, RTD 36-05, 60-05 RADIO. LEADWIRE
K901780 · DSA
Medtronic Vascular
Cardiovascular · 175d
Cleared Oct 09, 1990
ACUSOURCE 600 FOR USE WITH TMJ ELECTRODE
K901902 · NUW
Microcurrent Research, Inc.
Dental · 165d
Cleared Oct 09, 1990
RASCAL II RESPIRATORY AND ANESTHETIC GAS MONITOR
K902021 · CBQ
Albion Instruments
Anesthesiology · 159d
Cleared Oct 09, 1990
ALTIS (RESIN, CROWN AND BRIDGES)
K902040 · EBF
Pb2 Investment, Inc.
Dental · 158d
Cleared Oct 09, 1990
ENDOCERVICAL ASPIRATOR
K902242 · HFC
Innovative Medical Products, Inc.
Obstetrics & Gynecology · 144d
Cleared Oct 09, 1990
SONICATH(TM) 9F, 12 MHZ
K902245 · ITX
Boston Scientific Corp
Radiology · 144d
Cleared Oct 09, 1990
NIDEK US-2500 W/BIOMETRY UNIT US-2520
K902411 · IYO
Nidek, Inc.
Radiology · 131d
Cleared Oct 09, 1990
MODIFIED HEARING AID (IN-THE-EAR)
K902487 · ESD
Audio Hearing Aid Service
Ear, Nose, Throat · 130d
Cleared Oct 09, 1990
AUTOMATIC CASSETTE LOADER
K902761 · KPX
Mallinckrodt Group, Inc.
Radiology · 106d
Cleared Oct 09, 1990
AUDIOPRAT ENDOSCOPE
K903012 · EHB
S.C.D.P.I. of Florida, Inc.
Radiology · 90d
Cleared Oct 09, 1990
SURGITEK(R) TURP MONITOR
K903127 · GEI
Surgitek Medical Engineering Corp.
General & Plastic Surgery · 85d
Cleared Oct 09, 1990
MICROSPACER TM
K903413 · CAF
Respiratory Delivery Systems, Inc.
Anesthesiology · 71d
Cleared Oct 09, 1990
ITE HEARING AID, SOUND MED EMERALD MODEL
K903415 · ESD
Improved Hearing Service, Inc.
Ear, Nose, Throat · 71d
Cleared Oct 09, 1990
AUDIOTECH MODEL CL
K903478 · ESD
Muskogee Regional Hearing Aid Lab
Ear, Nose, Throat · 68d