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
128785–128808 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 22, 1989
ADMS MULTIPLANE RECTAL PROBE
K895359 · ITX
Avalon Technology Corp.
Radiology · 86d
Cleared Nov 22, 1989
PROXIMAL CEMENT SPACER
K895378 · JDK
Osteonics Reconstructive Products Div.
Orthopedic · 84d
Cleared Nov 22, 1989
ACROMED DOUBLE SUBLAMINAR WIRE
K895413 · KWP
Acromed Corp.
Orthopedic · 78d
Cleared Nov 22, 1989
ACROMED BEADED SUBLAMINAR WIRE
K895439 · KWP
Acromed Corp.
Orthopedic · 78d
Cleared Nov 22, 1989
ACROMED BUTTON SPINAL WIRE
K895441 · KWP
Acromed Corp.
Orthopedic · 78d
Cleared Nov 22, 1989
THE SHUTTLE (TM) THREE WHEEL SCOOTER
K896025 · INI
Pride Health Care, Inc.
Physical Medicine · 36d
Cleared Nov 22, 1989
STERILE HYPOALLERGENIC SURGEONS' GLOVES
K896165 · KGO
Isratech Marketing Corp.
General Hospital · 28d
Cleared Nov 22, 1989
STATSPIN STATSAMPLER
K896206 · JKA
Statspin Technologies
Chemistry · 27d
Cleared Nov 22, 1989
VS22 HIP PROSTHESIS
K896266 · KWY
3M Company
Orthopedic · 23d
Cleared Nov 22, 1989
MICRO-AIRE OSCILLATING SAW BLADE 202C-25, 202C-50
K896280 · GFA
Micro-Aire Surgical Instruments, Inc.
General & Plastic Surgery · 22d
Cleared Nov 21, 1989
TRICON-M TOTAL KNEE SYSTEM
K884824 · MBV
Richards Medical Co., Inc.
Orthopedic · 368d
Cleared Nov 21, 1989
VASCULAR TECHNOLOGY UNIOX OXYGEN ALARM
K890058 · CCL
Vascular Technology Incorporated
Anesthesiology · 319d
Cleared Nov 21, 1989
ELECTRODELCA
K892659 · IZG
Oldelft Corp. of America
Radiology · 222d
Cleared Nov 21, 1989
NET STRETCHER PAD (TM)
K892892 · FPP
North East Technology
General Hospital · 215d
Cleared Nov 21, 1989
LATEX SURGICAL GLOVES
K892922 · KGO
Millimax Corp.
General Hospital · 223d
Cleared Nov 21, 1989
EPO-TRAC BY RADIOIMMUNOASSAY (RIA)
K893393 · GGT
Incstar Corp.
Chemistry · 204d
Cleared Nov 21, 1989
TENS PREP
K893604 · GYB
Smith & Nephew United, Inc.
Neurology · 189d
Cleared Nov 21, 1989
LATEX EXAMINATION GLOVES
K893937 · LYY
Sai Latex Private , Ltd.
General Hospital · 174d
Cleared Nov 21, 1989
STUDIO UNO
K894061 · EIA
Eurodent, Inc.
Dental · 167d
Cleared Nov 21, 1989
GAMMAMED IRIDIUM-192 SOURCE
K894381 · JAQ
Mick Radio-Nuclear Instruments, Inc.
Radiology · 127d
Cleared Nov 21, 1989
CARIBBEAN LATEX PRODUCTS EXAMINATION GLOVES
K894751 · LYY
Caribbean Latex Products, Inc.
General Hospital · 118d
Cleared Nov 21, 1989
AGISHI ASCITES PUMP PERITONEOCAVAL SHUNT PUMP
K894794 · KPM
Vitaid, Ltd.
Gastroenterology & Urology · 116d
Cleared Nov 21, 1989
PURITAN-BENNETT OXYGEN CONCENTRATION INDICATOR
K895177 · CAW
Puritan Bennett Corp.
Anesthesiology · 103d
Cleared Nov 21, 1989
LATEX PATIENT EXAMINATION GLOVE
K895497 · LYY
Plymouth , Ltd.
General Hospital · 85d