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
44593–44616 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 10, 2012
NOTOUCH BREASTSCAN
K113259 · LHQ
Ue Lifesciences, Inc.
Radiology · 98d
Cleared Feb 10, 2012
VITEK 2 STREPTOCOCCUS TRIMETHOPRIM/SULFAMETHOXAZOLE
K113305 · LON
bioMerieux, Inc.
Microbiology · 93d
Cleared Feb 10, 2012
SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS)
K113362 · HRX
Spine View, Inc.
Orthopedic · 87d
Cleared Feb 10, 2012
SALTER LABS BUBBLE HUMIDIFIER (HIGH FLOW)
K113542 · BTT
Salter Labs, Arvin Facility
Anesthesiology · 71d
Cleared Feb 10, 2012
AIDA V1.5 DIAGNOSTIC ULTRASOUND SYSTEM GM-72P00A
K113612 · IYN
Panasonic Healthcare Co., Ltd.
Radiology · 66d
Cleared Feb 10, 2012
EIGR SURGICAL ILLUMINATION SYSTEM
K113697 · FST
Invuity, Inc.
General & Plastic Surgery · 56d
Cleared Feb 10, 2012
SENSE MSK S 8CH 1.5T
K120122 · MOS
Invivo Corporation
Radiology · 24d
Cleared Feb 10, 2012
REGIUS SIGMA2
K120131 · MQB
Konica Minolta Medical & Graphic, Inc.
Radiology · 24d
Cleared Feb 10, 2012
AMID STAPLER
K120268 · GDW
Safestich Medical, LLC
General & Plastic Surgery · 11d
Cleared Feb 09, 2012
FLEXI-Q DV AND DVR AUTO-INJECTORS
K111467 · KZH
Elcam Medical Acal
General Hospital · 259d
Cleared Feb 09, 2012
HAMILTON-TC1
K112006 · CBK
Hamilton Medical AG
Anesthesiology · 211d
Cleared Feb 09, 2012
SMITH MEDICAL PEEL-AWAY SHEATH INTRODUCERS
K112407 · DYB
Smiths Medical MD, Inc.
Cardiovascular · 171d
Cleared Feb 09, 2012
STIMULATION/DISSECTION INSTRUMENTS
K112709 · ETN
Nu Vasive, Incorporated
Ear, Nose, Throat · 143d
Cleared Feb 09, 2012
INTEGRA WOUND MATRIX (THIN)
K113104 · KGN
Integra LifeSciences Corporation
General & Plastic Surgery · 112d
Cleared Feb 09, 2012
PMS8210A (IRIS) MULTI-PARAMETER PATIENT MONITOR, MODEL CODE 500
K113183 · MWI
Shanghai 3f Electronics Co, Ltd.
Cardiovascular · 104d
Cleared Feb 09, 2012
DYNATRON TRI-WAVE LIGHT PAD DYNATRON TRI-WAVE LIGHT PROBE
K113250 · ILY
Dynatronics Corp.
Physical Medicine · 98d
Cleared Feb 09, 2012
CD HORIZON VOYAGER SPINAL SYSTEM
K113529 · NKB
Medtronic Sofamor Danek
Orthopedic · 71d
Cleared Feb 09, 2012
HPR EMOLLIENT FOAM
K113772 · FRO
Prugen IP Holdings, Inc.
General & Plastic Surgery · 49d
Cleared Feb 09, 2012
HPR PLUS EMOLLIENT FOAM
K113774 · FRO
Prugen IP Holdings, Inc.
General & Plastic Surgery · 49d
Cleared Feb 09, 2012
AFX INTRODUCER SYSTEM
K120212 · DYB
Endologix, Inc.
Cardiovascular · 16d
Cleared Feb 08, 2012
JARIT TAKE-APART ENDOSCOPIC INSTRUMENTS
K103726 · KNF
Integra LifeSciences Corporation
Obstetrics & Gynecology · 413d
Cleared Feb 08, 2012
ORTHOSLENDERIZER
K111249 · EFB
Orthomatics, Inc.
Dental · 281d
Cleared Feb 08, 2012
CLEARFLASH AC2100 COSMETIC SYSTEM
K111937 · OLP
Clearflash Technologies, Inc.
General & Plastic Surgery · 215d
Cleared Feb 08, 2012
YOMURA SAFETY I.V. CATHETER
K112542 · FOZ
Yomura Technologies, Inc.
General Hospital · 160d