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
123793–123816 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 19, 1990
BONE RASPS
K905187 · HSZ
Micro Surgical Instruments Corp.
Orthopedic · 30d
Cleared Dec 19, 1990
YANKAUER SUCTION DEVICE
K905478 · MDM
Medovations, Inc.
General & Plastic Surgery · 13d
Cleared Dec 19, 1990
ZOETIC GLOVES
K905515 · LYY
Janco Polymers Pvt., Ltd.
General Hospital · 9d
Cleared Dec 19, 1990
PATIENT EXAMINATION GLOVES
K905550 · LYY
Medical Device Inspection Co., Inc.
General Hospital · 8d
Cleared Dec 18, 1990
CONTROL-TIP CYSTOSCOPIC ELECTRODES
K903156 · FAS
North American Sterilization &...
Gastroenterology & Urology · 153d
Cleared Dec 18, 1990
FLEXIBLE ENDOSCOPIC ELECTRODES
K903162 · FAS
North American Sterilization &...
Gastroenterology & Urology · 153d
Cleared Dec 18, 1990
TOPCON EC-200 ENDO-PHOTOCOAGULATOR LASER
K903421 · HQF
Top Con
Ophthalmic · 140d
Cleared Dec 18, 1990
TOXO-CUBE
K903968 · LGD
Difco Laboratories, Inc.
Microbiology · 112d
Cleared Dec 18, 1990
NITRO BLUE TETRAZOLIUM REDUCTION
K904022 · GHD
Sigma Chemical Co.
Pathology · 110d
Cleared Dec 18, 1990
LOCAL REPORT GENERATOR
K904318 · DXN
Spacelabs, Inc.
Cardiovascular · 89d
Cleared Dec 18, 1990
DISPOSABLE FIBER OPTIC DELIVERY SYST/ND: YAG SURG
K904407 · GEX
Fiber Delivery Concepts, Inc.
General & Plastic Surgery · 83d
Cleared Dec 18, 1990
XENON LIGHT SOURCE
K904609 · HBI
Medical Dynamics, Inc.
General & Plastic Surgery · 68d
Cleared Dec 18, 1990
FLOWERS NASAL IMPLANT
K904656 · FZE
Implantech Associates, Inc.
General & Plastic Surgery · 64d
Cleared Dec 18, 1990
FLOWERS DORSAL COLUMELLA IMPLANT
K904657 · FZE
Implantech Associates, Inc.
General & Plastic Surgery · 64d
Cleared Dec 18, 1990
VLS 5300 300W XENON LIGHT SOURCE
K904681 · HBI
Vistek Corp.
General & Plastic Surgery · 64d
Cleared Dec 18, 1990
VISTEK ELECTRONIC CONTROLLER
K904682 · GEY
Vistek Corp.
General & Plastic Surgery · 64d
Cleared Dec 18, 1990
LYTENING TM 6/R
K904726 · JFP
Amdev, Inc.
Chemistry · 62d
Cleared Dec 18, 1990
CHOLESTRECH L.D.X (TM) LEVEL 2 CONTROL
K904781 · JJY
Cholestrech Corp.
Chemistry · 57d
Cleared Dec 18, 1990
CHOLESTECH L.D.X. LEVEL 1 CONTROL
K904784 · JJY
Cholestech Corp.
Chemistry · 57d
Cleared Dec 18, 1990
MICROZYME T3 ENZYME IMMUNOASSAY KIT
K904820 · CDP
Immunotech Corp.
Immunology · 55d
Cleared Dec 18, 1990
DIGITCARE I.V. START KIT
K905009 · FOZ
Digitcare Corp.
General Hospital · 41d
Cleared Dec 18, 1990
ELEGANCE TSH ELISA
K905099 · JLW
Bioclone Australia Pty , Ltd.
Chemistry · 35d
Cleared Dec 17, 1990
WILSON BIOMEDICAL ANGIOGRAPHIC CATHETER
K892671 · DQO
Wilson Biomedical, Inc.
Cardiovascular · 615d
Cleared Dec 17, 1990
MEDI LISS DENTAL ANALGESIA DEVICE (SBL601)
K900731 · LWM
Medical Consultants Intl. , Ltd.
Dental · 305d