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
124633–124656 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Oct 09, 1990
AUDIOTECH MODEL DB
K903479 · ESD
Muskogee Regional Hearing Aid Lab
Ear, Nose, Throat · 68d
Cleared Oct 09, 1990
MASCOT THERMOTER
K903500 · FLK
Mascot, Inc.
General Hospital · 67d
Cleared Oct 09, 1990
SCIMED ENCORE INFLATION DEVICE, MODEL SM2500
K903503 · MAV
Scimed
Cardiovascular · 67d
Cleared Oct 09, 1990
SERIES MCAXX (MODEL 851) ITE HEARING AID
K903583 · ESD
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 62d
Cleared Oct 09, 1990
HELIOLINK TRY-IN PASTES
K903587 · EBF
Ivoclar North America, Inc.
Dental · 62d
Cleared Oct 09, 1990
ADVANCE LASER FLOWMETER, ALF 21
K903633 · DPW
Transonic Systems, Inc.
Cardiovascular · 60d
Cleared Oct 09, 1990
DATASCOPE PERCOR STAT DL10.5 FR40CC IN AORTIC BAL
K903736 · DSP
Datascope Corp.
Cardiovascular · 54d
Cleared Oct 09, 1990
ITE HEARING AID, DIAMOND MODEL
K903859 · ESD
Improved Hearing Service, Inc.
Ear, Nose, Throat · 71d
Cleared Oct 09, 1990
ITE HEARING AID, SAAPHIRE MODEL
K903860 · ESD
Improved Hearing Service, Inc.
Ear, Nose, Throat · 71d
Cleared Oct 09, 1990
ITE HEARING AID, SOUND MED GOLDEN NUGGET MODEL
K903861 · ESD
Improved Hearing Service, Inc.
Ear, Nose, Throat · 71d