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
36313–36336 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 15, 2014
OBERON: LASER SURGERY FIBER, ATRAUMATIC SURGERY FIBER, SIDE FIRE FIBER,...
K140470 · GEX
Oberon GmbH Fiber Technologies
General & Plastic Surgery · 232d
Cleared Oct 15, 2014
STRATAFIX SYMMETRIC PDS PLUS KNOTLESS TISSUE CONTROL DEVICES
K141776 · NEW
Ethicon, Inc.
General & Plastic Surgery · 105d
Cleared Oct 15, 2014
DANA
K141865 · LQD
Anthrotronix, Inc.
Neurology · 97d
Cleared Oct 15, 2014
XCEL 455 SLIT LAMP
K141954 · HJO
Reichert, Inc.
Ophthalmic · 89d
Cleared Oct 15, 2014
RENOVIS S134 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM
K142095 · OVD
Renovis Surgical Technologies, Inc.
Orthopedic · 75d
Cleared Oct 15, 2014
COGENT MED-LIF XL
K142193 · MAX
Cogent Spine, LLC
Orthopedic · 65d
Cleared Oct 15, 2014
Urine/CSF Albumin, Urine/CSF Albumin Calibrator
K142346 · DCF
Beckman Coulter Ireland, Inc.
Chemistry · 54d
Cleared Oct 14, 2014
JULIET PO
K142277 · MAX
Spineart
Orthopedic · 60d
Cleared Oct 14, 2014
PICC Maximal Barrier Nursing Kit
K142616 · LJS
Navilyst Medical, Inc.
General Hospital · 28d
Cleared Oct 10, 2014
HS NOTA
K131925 · FCG
H.S. Hospital Services S.P.A.
Gastroenterology & Urology · 471d
Cleared Oct 10, 2014
ONESTEP CPR II MULTI-FUNCTION ELECTRODE
K133441 · MKJ
Bio-Detek, Inc.
Cardiovascular · 332d
Cleared Oct 10, 2014
EPIC 10
K140120 · GEX
Biolase, Inc.
General & Plastic Surgery · 267d
Cleared Oct 10, 2014
INTEGRA EXTERNAL FIXATION SYSTEM
K140463 · KTT
Ascension Orthopedic
Orthopedic · 228d
Cleared Oct 10, 2014
MECA XPRESSFISH
K140619 · MYI
Advandx, Inc.
Microbiology · 213d
Cleared Oct 10, 2014
OSTOM-I ALERT
K140938 · EXB
11 Health and Technologies, LLC
Gastroenterology & Urology · 182d
Cleared Oct 10, 2014
FRONTIER DEVICES FUSIO SCREW FUZE SYSTEM
K141106 · OUR
Folsom Metal Products, Inc. Dba...
Orthopedic · 164d
Cleared Oct 10, 2014
FREEDOM SPINAL CORD STIMULATOR (SCS) SYSTEM
K141399 · GZB
Stimwave Technologies Incorporated
Neurology · 135d
Cleared Oct 10, 2014
QFLOW 500 TITANIUM BOLT, QUAD LUMEN BOLT KIT
K141869 · GWM
Hemedex Incorporated
Neurology · 91d
Cleared Oct 10, 2014
SOFIA DISTAL ACCESS CATHETER
K142014 · DQY
MicroVention, Inc.
Cardiovascular · 78d
Cleared Oct 10, 2014
VERIGENE ENTERIC PATHOGEN NUCLEIC ACID TEST (EP)
K142033 · PCH
Nanospere,Inc.
Microbiology · 77d
Cleared Oct 10, 2014
QUANTRA
K142037 · LLZ
Hologic, Inc.
Radiology · 74d
Cleared Oct 10, 2014
LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM
K142160 · IYN
Ge Healthcare
Radiology · 65d
Cleared Oct 10, 2014
Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic Ultrasound System
K142323 · IYN
Ge Medical Systems Israel , Ltd.
Radiology · 51d
Cleared Oct 10, 2014
AngioDynamics VenaCure EVLT Tre’ Sheath and VenaCure EVLT NeverTouch...
K142614 · GEX
AngioDynamics, Inc.
General & Plastic Surgery · 24d