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
124489–124512 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 19, 1990
ARTERIAL EMBOLECTOMY CATHETER
K901627 · DXE
Applied Vascular Devices, Inc.
Cardiovascular · 193d
Cleared Oct 19, 1990
STATLOCK IV CONNECTOR AND ANCHOR SET
K902109 · FPA
Venetec, Inc.
General Hospital · 163d
Cleared Oct 19, 1990
THE GUIDER CORONARY GUIDING CATHETER
K903216 · DQY
Intec Medical, Inc.
Cardiovascular · 88d
Cleared Oct 19, 1990
TAPERED TIP THE GUIDER CORONARY GUIDING CATHETER
K903217 · DQY
Intec Medical, Inc.
Cardiovascular · 88d
Cleared Oct 19, 1990
ACCUFLEX/ACCUMIX VINYL POLY IMPRESSION MATERIALS
K903292 · ELW
Coe Laboratories, Inc.
Dental · 87d
Cleared Oct 19, 1990
CYGNASCOPE
K903312 · HRX
Cygnus Instruments, Inc.
Orthopedic · 86d
Cleared Oct 19, 1990
PYMAH PRE-GAGED BALANCED TEMPA-KUFF
K903379 · DXQ
Pymah Corp.
Cardiovascular · 81d
Cleared Oct 19, 1990
SARNS MEMBRANE OXGENATOR PART NUMBER 9443
K903436 · DTZ
3M Health Care, Sarns
Cardiovascular · 80d
Cleared Oct 19, 1990
PRECISION OPTICS IMAGE BEAMSPLITTER (COUPLER)
K903457 · FET
Precise Optics
Gastroenterology & Urology · 79d
Cleared Oct 19, 1990
PRECISION OPTICS IMAGE COUPLER
K903458 · FET
Precise Optics
Gastroenterology & Urology · 79d
Cleared Oct 19, 1990
STERI-SHIELD
K903533 · FXY
Biomedical Devices, Inc.
General Hospital · 74d
Cleared Oct 19, 1990
O.R. TIP CLEANER
K903610 · GEI
Inman Liebelt Corp.
General & Plastic Surgery · 71d
Cleared Oct 19, 1990
MODEL 90421 FLEXPORT INTERFACE
K903702 · DQA
Spacelabs, Inc.
Anesthesiology · 80d
Cleared Oct 19, 1990
PERCOR STAT DL 9.5 FR 34CC INTRA-AORTIC BALLOON
K903769 · DSP
Datascope Corp.
Cardiovascular · 60d
Cleared Oct 19, 1990
CLUB FOOT CPM MACHINE
K903851 · BXB
Smith & Nephew Richards, Inc.
Physical Medicine · 59d
Cleared Oct 19, 1990
DATASCOPE PERCOR STAT DL 10.5 FR 40CC
K903867 · DSP
Datascope Corp.
Cardiovascular · 58d
Cleared Oct 19, 1990
DATASCOPE PERCOR STAT 8.5 FR 40CC INTRA-AORTIC BAL
K903892 · DSP
Datascope Corp.
Cardiovascular · 58d
Cleared Oct 19, 1990
DATASCOPE PERCOR STAT 9.5 FR 40CC INTRA-AORTIC BAL
K903893 · DSP
Datascope Corp.
Cardiovascular · 58d
Cleared Oct 19, 1990
URETEROPYELOGRAM CATH FOR RETROGRADE DYE INJECTION
K903994 · FGF
Applied Urology, Inc.
Gastroenterology & Urology · 51d
Cleared Oct 19, 1990
DATASCOPE PERCOR STAT DL 9.5 FR 40CC INTRA-AOR BAL
K904018 · DSP
Datascope Corp.
Cardiovascular · 50d
Cleared Oct 19, 1990
CARBON DIOXIDE FLOWTHROUGH LASER MIXTURES
K904162 · GEX
Norco, Inc.
General & Plastic Surgery · 38d
Cleared Oct 19, 1990
FASTLOK (STAPLE AND BUCKLE) FIXATION SYSTEM
K904340 · JDR
Neoligaments, Ltd.
Orthopedic · 29d
Cleared Oct 19, 1990
CRYSTAL FOCUS EMERALD-CW LASER PHOTOCOAGULATOR
K904366 · HQF
Douglas James Donaldson Compliance...
Ophthalmic · 25d
Cleared Oct 19, 1990
LATEX EXAMINATION GLOVES(MFG: MODLOOK INDUSTRIES)
K904641 · LYY
Predex Co. , Ltd.
General Hospital · 8d