FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
39121–39144 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 22, 2013
ADHESIVE ELECTRODES
K132588 · GXY
Top-Rank Health Care Equipment Co., Ltd.
Neurology · 95d
Cleared Nov 22, 2013
V8 TRANSLUMINAL BAV CATHETER
K132728 · OZT
Intervalve, Inc.
Cardiovascular · 80d
Cleared Nov 22, 2013
SENSE-4BABY SYSTEM
K132918 · HGM
Sense4baby , Inc.
Obstetrics & Gynecology · 66d
Cleared Nov 22, 2013
ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT
K133067 · CDT
Siemens Healthcare Diagnostics, Inc.
Chemistry · 56d
Cleared Nov 22, 2013
CRESCENT SPINAL SYSTEM
K133216 · MAX
Medtronic Sofamor Danek, Inc.
Orthopedic · 35d
Cleared Nov 22, 2013
ELECSYS CK-MB CALCHECK 5
K133284 · JJX
Roche Diagnostics
Chemistry · 28d
Cleared Nov 22, 2013
DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
K133399 · MCW
Cardiovascular Systems Incorporated
Cardiovascular · 16d
Cleared Nov 21, 2013
RANDOX LIQUID CK-MB, RANDOX CK-MB CALIBRATOR
K123977 · CGS
Randox Laboratories, Ltd.
Chemistry · 330d
Cleared Nov 21, 2013
AUDIFON ARRIVA CIC, IS, IS+, M, S, S+, X TRT, AUDIFON VICO, AUDIFON PRADO,...
K130514 · KLW
Audifon-USA, Inc.
Ear, Nose, Throat · 267d
Cleared Nov 21, 2013
MALDI BIOTYPER CA (MBT-CA) SYSTEM
K130831 · PEX
Bruker Daltonics, Inc.
Microbiology · 240d
Cleared Nov 21, 2013
INFLAMMA DRY
K132066 · PFQ
Rapid Pathogen Screening, Inc.
Chemistry · 141d
Cleared Nov 21, 2013
PERSYST 12 EEG REVIEW AND ANALYSIS SOFTWARE
K132306 · OMB
Persyst Development Corp.
Neurology · 120d
Cleared Nov 20, 2013
HAMILTON-MR1
K122438 · CBK
Hamilton Medical AG
Anesthesiology · 467d
Cleared Nov 20, 2013
SAFETY HYPODERMIC NEEDLES WITH/WITHOUT SYRINGE
K130212 · FMI
Wuxi Yushou Medical Applicances Co.,...
General Hospital · 295d
Cleared Nov 20, 2013
STERILE PISTON HYPODERMIC SYRINGES (WITH/WITHOUT NEEDLE), HYPODERMIC NEEDLES
K130230 · FMF
Wuxi Yushou Medical Applicances Co.,...
General Hospital · 295d
Cleared Nov 20, 2013
ISIRONA MAGELLAN
K130707 · MSX
Isirona, LLC
Cardiovascular · 250d
Cleared Nov 20, 2013
WRIGHT GRADIENT 52 - TORSO
K131387 · JOW
Wright Therapy Products, Inc.
Cardiovascular · 190d
Cleared Nov 20, 2013
MRI MARKER
K131689 · KXK
C4 Imaging, LLC
Radiology · 163d
Cleared Nov 20, 2013
BRONCHOSCOPY ELBOW
K132168 · BZD
Respironics, Inc.
Anesthesiology · 131d
Cleared Nov 20, 2013
MULTICAM 3000 ECO
K132347 · KPS
Inter Medical Medizintechnik GmbH
Radiology · 114d
Cleared Nov 20, 2013
AFFIX II SPINOUS PROCESS PLATE SYSTEM
K132411 · PEK
Nu Vasive, Incorporated
Orthopedic · 110d
Cleared Nov 20, 2013
APEX SPINE SYSTEM
K132603 · NKB
Spinecraft, LLC
Orthopedic · 92d
Cleared Nov 20, 2013
RETROARC RETROPUBIC SLING SYSTEM
K132655 · OTN
American Medical Systems, Inc.
Gastroenterology & Urology · 86d
Cleared Nov 20, 2013
EVEREST SPINAL SYSTEM
K132757 · MNI
K2m, Inc.
Orthopedic · 77d