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
135649–135672 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 14, 1988
SANAPLAST
K881397 · KGX
Nebo Industries
General & Plastic Surgery · 71d
Cleared Jun 14, 1988
CERVICATH
K881414 · HDR
Epcom Medical Systems, Inc.
Obstetrics & Gynecology · 71d
Cleared Jun 14, 1988
OMNI-VENT, SERIES D/MRI
K881420 · CBK
Stein-Gates Medical Equipment, Inc.
Anesthesiology · 71d
Cleared Jun 14, 1988
MODIFIED SPQ(TM) TEST SYSTEM FOR APOLIPOPROTEIN B
K881898 · MSJ
Atlantic Antibodies
Immunology · 47d
Cleared Jun 13, 1988
BIONIC-TOOTH-PLANT MODEL A-1
K873437 · DZE
Larry R. Ashkinazy, D.D.S.
Dental · 291d
Cleared Jun 13, 1988
CONDOM (PROPHYLACTIC)
K880463 · HIS
Health Technologies Intl.
Obstetrics & Gynecology · 131d
Cleared Jun 13, 1988
MAXIMUM CURE SEALANT
K880791 · DYH
Reliance Orthodontic Products, Inc.
Dental · 108d
Cleared Jun 13, 1988
LIGHT BOND
K880793 · DYH
Reliance Orthodontic Products, Inc.
Dental · 108d
Cleared Jun 13, 1988
CENTRASIL SILICONE ELASTOMER CENTRAL VENOUS CATH
K881215 · FOZ
Baxter Healthcare Corp
General Hospital · 83d
Cleared Jun 13, 1988
VENOVALVE(TM)
K881234 · FPA
Abbott Laboratories
General Hospital · 84d
Cleared Jun 13, 1988
CMI VACUUM DELIVERY SYSTEM #003C AND #004C
K881306 · HDB
Challenge Mfg., Inc.
Obstetrics & Gynecology · 77d
Cleared Jun 13, 1988
ENDOSSEOUS DENTAL IMPLANT
K881924 · DZE
Bone Anchorage Systems, Inc.
Dental · 35d
Cleared Jun 13, 1988
CMI VACUUM PUMP #001C - VACUUM PUMP (NON-ELECTRI.)
K881967 · HDB
Challenge Mfg., Inc.
Obstetrics & Gynecology · 33d
Cleared Jun 13, 1988
CLEARFIL PHOTO CORE
K882006 · EBF
Kuraray Co.
Dental · 31d
Cleared Jun 13, 1988
MAGNE-DENT MAGNET/ZEST RETROFIT KEEPER
K882063 · EGG
Zest Anchors, Inc.
Dental · 28d
Cleared Jun 13, 1988
DENTORIDGE(TM) HYDROXYYLAPATITE
K882098 · LYC
Norian Corp.
Dental · 25d
Cleared Jun 13, 1988
JEL-5 GOLD BASED ALLOYS & PRECIOUS METAL ALLOYS
K882126 · EJT
J.F. Jelenko & Co., Inc.
Dental · 24d
Cleared Jun 10, 1988
SOLID PHASE DETER SERUM CHOLESTEROL FR WHOLE BLOOD
K864159 · CHH
Chem-Elec, Inc.
Chemistry · 596d
Cleared Jun 10, 1988
AMBULATORY BLOOD PRESSURE MONITOR
K873764 · DXN
Pulsetrend, Inc.
Cardiovascular · 268d
Cleared Jun 10, 1988
JETPOLISHER(TM)
K875340 · KOJ
Young Dental Manufacturing Co. 1, LLC
Dental · 163d
Cleared Jun 10, 1988
VELEX WOVEN DACRON LOW PORSITY VASCULAR GRAFT
K880041 · DSY
D-R Medical Systems, Inc.
Cardiovascular · 157d
Cleared Jun 10, 1988
DATASCOPE PERCOR STAT-MIL 9.5 FR INTRA-AORTIC BALL
K880289 · DSP
Datascope Corp.
Cardiovascular · 137d
Cleared Jun 10, 1988
MODEL 800 O.B. DATA ARCHIVAL SYSTEM
K880419 · HGM
Ge Medical Systems Information...
Obstetrics & Gynecology · 130d
Cleared Jun 10, 1988
RAICHEM(TM) CALCIUM REAGENT (SINGLE STABLE LIQUID)
K880576 · CJY
Reagents Applications, Inc.
Chemistry · 121d