FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
76777–76800 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 04, 2001
CRP-LATEX (II) SEIKEN HIGH SENSITIVITY ASSAY KIT
K011958 · DCN
Denka Seiken'S
Chemistry · 165d
Cleared Dec 04, 2001
MEDTRONIC DLP ARTERIAL CANNULA WITH 3D TIP - 22 FR.
K013013 · DWF
Medtronic Cardiac Surgical Products
Cardiovascular · 88d
Cleared Dec 04, 2001
SELECTIVA GUIDEWIRE
K013024 · DQX
Neometrics, Inc.
Cardiovascular · 88d
Cleared Dec 04, 2001
MODIFICATION TO VIKING OPTIMA GUIDING CATHETER
K013638 · DQY
Guidant Corp.
Cardiovascular · 29d
Cleared Dec 03, 2001
IMAGYN ISOSLEEVE / ISOSTAR NEEDLE SYSTEM
K010166 · IWJ
Imagyn Medical Technologies, Inc.
Radiology · 319d
Cleared Dec 03, 2001
LIFEPAK 600 AUTOMATED EXTERNAL DEFIBRILLATOR
K011144 · MKJ
Medtronic Physio-Control Corp.
Cardiovascular · 231d
Cleared Dec 03, 2001
MENTOR CONTOUR PROFILE TISSUE EXPANDER
K011500 · LCJ
Mentor Corp.
General & Plastic Surgery · 201d
Cleared Dec 03, 2001
MACROPORE SURGIWRAP (TS)
K012025 · FTL
Macropore Biosurgery, Inc.
General & Plastic Surgery · 158d
Cleared Dec 03, 2001
ENT LASERVISION
K012071 · GEX
Union Medical USA
General & Plastic Surgery · 154d
Cleared Dec 03, 2001
COMPANION MODEL 221, 321, 421
K012258 · INI
Golden Technologies, Inc.
Physical Medicine · 138d
Cleared Dec 03, 2001
TRIMAX
K012268 · FYA
Standard Textile Co., Inc.
General Hospital · 137d
Cleared Dec 03, 2001
MODIFICATION TO: STRYKER NAVIGATION SYSTEM, STRYKER FLUOROSCOPY...
K012380 · HAW
Stryker Leibinger
Neurology · 130d
Cleared Dec 03, 2001
RESORBABLE NO PROFILE SCREW AND WASHER
K012469 · HWC
Biomet Manufacturing, Inc.
Orthopedic · 123d
Cleared Dec 03, 2001
SOFT TISSUE SCREW AND WASHER
K012572 · HWC
Biomet, Inc.
Orthopedic · 116d
Cleared Dec 03, 2001
SYNTHES 2.4 MM CANNULATED SCREW
K012945 · HWC
Synthes (Usa)
Orthopedic · 90d
Cleared Dec 03, 2001
APPLIED ACCESS SEAL
K012968 · GCJ
Applied Medical Resources Corp.
General & Plastic Surgery · 90d
Cleared Dec 03, 2001
SYNTHES 3.9 MM PELVIC SCREWS
K013044 · HWC
Synthes (Usa)
Orthopedic · 84d
Cleared Dec 03, 2001
AVID-NIT PLASTIC HUB LUTZ EPIDURAL NEEDLE,MODEL RP2035L, AVID-NIT METAL HUB...
K013231 · BSP
Avid N.I.T., Inc.
Anesthesiology · 67d
Cleared Dec 03, 2001
NIPRO SAFELET CATH
K013287 · FOZ
Nipro Medical Corp.
General Hospital · 62d
Cleared Dec 03, 2001
NON-STERILE POWDER FREE GREEN LATEX EXAMINATION GLOVES WITH ALOE VERA AND...
K013288 · LYY
Sgmp Co., Ltd.
General Hospital · 62d
Cleared Dec 03, 2001
REMINGTON PARAFFIN SPA, MODELS HS-200. PFS-600
K013328 · IMC
Remington Products Company, LLC
Physical Medicine · 59d
Cleared Dec 03, 2001
MICROMARK II TISSUE MARKER,MODEL C1535
K013413 · NEU
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 49d
Cleared Dec 03, 2001
SIMPLICITY CLASSIC WING QD INFUSION SET
K013502 · FPA
Sterling Medivations, Inc.
General Hospital · 42d
Cleared Dec 03, 2001
MODIFICATION TO AGILENT COMPONENT MONITORING SYSTEM (CMS), V24/V26 PATIENT...
K013624 · MHX
Philips Medizin Systeme Boblingen GmbH
Cardiovascular · 28d