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
122113–122136 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 13, 1991
MINISCOPE
K910587 · HRX
Citation Medical Corp.
Orthopedic · 90d
Cleared May 13, 1991
MENTOR(R) SUR-E-TROL(R)
K910637 · FRN
Mentor O & O, Inc.
General Hospital · 89d
Cleared May 13, 1991
PS OMNIFIT NORMALIZED HIP STEM SERIES
K910662 · JDI
Osteonics Corp.
Orthopedic · 88d
Cleared May 13, 1991
PUMP VAC PLUS
K910907 · HET
Marlo Surgical Technology
Obstetrics & Gynecology · 69d
Cleared May 13, 1991
INVOTEC EAR DRAPE
K911039 · KKX
Invotec International, Inc.
General Hospital · 66d
Cleared May 13, 1991
OPHTA SIL (R), PUNCTAL PLUGS AND INSERTERS
K911108 · LZU
G.W.B. Intl., Ltd.
Ophthalmic · 70d
Cleared May 13, 1991
QUALTEX LIGHT HANDLE AND LIGHT HANDLE COVER
K911369 · MDM
Deroyal Industries, Inc.
General & Plastic Surgery · 46d
Cleared May 13, 1991
PRECISION GLIDE - ENHANCED SURGICAL BLADE
K911913 · GES
Bd Becton Dickinson Vacutainer...
General & Plastic Surgery · 13d
Cleared May 13, 1991
DISPOSABLE ISOLATION GOWN
K911921 · FYB
Liaoning-Usa Corp.
General Hospital · 13d
Cleared May 10, 1991
UCEZ - STERILE LENS FOG REDUCTION DEVICE
K905590 · OCT
Inman Liebelt Corp.
Gastroenterology & Urology · 148d
Cleared May 10, 1991
BACTI-SWAB
K910180 · JSM
Remel Co.
Microbiology · 115d
Cleared May 10, 1991
HITT BY HEMOCHRON(R)
K910181 · KFF
International Technidyne Corp.
Hematology · 114d
Cleared May 10, 1991
DOCUMENT REFLECTANCE II LINEARITY TEST SET
K910440 · JJY
Casco Standards
Chemistry · 99d
Cleared May 10, 1991
SUPERSERUM REAGENT (SSR)
K910646 · JKA
International Technidyne Corp.
Chemistry · 86d
Cleared May 10, 1991
MODEL GS-4700 COMMON DUCT STONE REMOVING KIT
K910671 · FGE
Solos Endoscopy, Inc.
Gastroenterology & Urology · 84d
Cleared May 10, 1991
BORRELIA BURGDORFERI POLYVAL IGG/IGM ANTIBODY TEST
K911145 · LSR
Medical Diagnostic Technologies, Inc.
Microbiology · 70d
Cleared May 09, 1991
GRAVITY PLUS CONTROLLER/COMPOUNDER
K902853 · LHI
Fergy Corp.
General Hospital · 314d
Cleared May 09, 1991
RAPID IMMOBILIZATION DEVICE OR R.I.D. SYSTEM
K904237 · FPP
Innovative Medical Technologies, Inc.
General Hospital · 234d
Cleared May 09, 1991
MODEL SW-103 SOLITANS STIMULATOR
K904264 · GZJ
Medical Consultants Intl. , Ltd.
Neurology · 233d
Cleared May 09, 1991
TROCAR ACCESS SHEATH
K905471 · HET
Cook Ob/Gyn
Obstetrics & Gynecology · 154d
Cleared May 09, 1991
LASER-35
K910200 · GEX
Endo Technic Corp.
General & Plastic Surgery · 114d
Cleared May 09, 1991
GLOVE-N-GEL AMNIOTOMY KIT
K910518 · HGE
Epcom Medical Systems, Inc.
Obstetrics & Gynecology · 92d
Cleared May 09, 1991
EDWARDS-WALLACE BOURNE HALL CATHETER
K910577 · MFD
Marlo Surgical Technology
Obstetrics & Gynecology · 87d
Cleared May 09, 1991
BOVIE MODEL X-10, X-10I, ELECTROSURGICAL GENERATOR
K910663 · GEI
Mdt Corp., Inc.
General & Plastic Surgery · 84d