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
36433–36456 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 26, 2014
DISCOVERY MR750 3.0T ,DISCOVERY MR450 1.5T, DISCOVERY MR750 3.0T,OPTIMA...
K142085 · LNH
Ge Medical Systems, LLC
Radiology · 57d
Cleared Sep 26, 2014
HEMASORB Resorbable Hemostatic Bone Putty
K142339 · MTJ
Orthocon, LLC
General & Plastic Surgery · 36d
Cleared Sep 26, 2014
I.T.S. Hand Locking Plates System - HLS
K142418 · HRS
I.T.S. GmbH
Orthopedic · 29d
Cleared Sep 25, 2014
PHILIPS CT DYNAMIC MYOCARDIAL PERFUSION (DMP) APPLICATION
K133603 · JAK
Philips Medical Systems
Radiology · 304d
Cleared Sep 25, 2014
PHANTOM XL INSULATED DILATORS
K140088 · PDQ
Tedan Surgical Innovations, LLC
Neurology · 254d
Cleared Sep 25, 2014
FLEXGUIDE ULTRA BEAMPATH ROBOTIC FIBER CONDUIT
K140378 · GEX
Omniguide, Inc.
General & Plastic Surgery · 223d
Cleared Sep 25, 2014
ELLIPSE I2PL+/ELLIPSE MULTIFLEX+
K140670 · ONF
Ellipse A/S
General & Plastic Surgery · 191d
Cleared Sep 25, 2014
DEMESTEEL (STAINLESS STEEL) NON-ABSORBABLE SUTURE
K141007 · GAQ
Demetech Corp.
General & Plastic Surgery · 160d
Cleared Sep 25, 2014
PTA BALLOON DILATATION CATHETER
K141150 · LIT
Boston Scientific Corp
Cardiovascular · 143d
Cleared Sep 25, 2014
CELLVIZIO 100 SERIES WITH SYSTEM CONFOCAL MINIPROBES
K141358 · OWN
Mauna Kea Technologies
General & Plastic Surgery · 125d
Cleared Sep 25, 2014
POLARIS SPINAL SYSTEM - HA COATED
K141804 · NKB
Biomet Spine, LLC
Orthopedic · 84d
Cleared Sep 25, 2014
SYNAPSE SYSTEM, SYNTHES OC FUSION SYSTEM
K141897 · KWP
Synthes USA Products, LLC
Orthopedic · 73d
Cleared Sep 25, 2014
ESOFLIP ES
K142000 · PIE
Crospon, Ltd.
Gastroenterology & Urology · 64d
Cleared Sep 25, 2014
Optima XR200amx, Optima XR220amx
K142383 · IZL
Ge Medical Systems, LLC
Radiology · 30d
Cleared Sep 25, 2014
FaStep Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup),...
K142408 · LDJ
Polymed Therapeutics, Inc.
Toxicology · 28d
Cleared Sep 25, 2014
TightRail Rotating Dilator Sheath/TightRail Mini Dilator Sheath
K142546 · DRE
Spectranetics, Inc.
Cardiovascular · 15d
Cleared Sep 24, 2014
STATSTRIP GLUCOSE HOSPITAL METER SYSTEM
K132121 · PZI
Nova Biomedical Corporation
Chemistry · 441d
Cleared Sep 24, 2014
POWER-TRIALYSIS SHORT-TERM DIALYSIS CATHETER
K133456 · NIE
C.R. Bard, Inc.
Gastroenterology & Urology · 316d
Cleared Sep 24, 2014
AMT ENDOTRACHEAL TUBE BRIDLE RETENTION SYSTEM
K140097 · CBH
Applied Medical Technology, Inc.
Anesthesiology · 253d
Cleared Sep 24, 2014
CONCHASMART BREATHING CIRCUIT
K140556 · BTT
Teleflex, Inc.
Anesthesiology · 203d
Cleared Sep 24, 2014
LUCID LY
K140837 · GEX
Bio-Med USA, Inc.
General & Plastic Surgery · 175d
Cleared Sep 24, 2014
SMARTGRAFT 30 SYSTEM
K141591 · MUU
Ingeneron, Inc.
General & Plastic Surgery · 103d
Cleared Sep 24, 2014
GLUCOVITAAL H1A BLOOD GLUCOSE MONITORING SYSTEM
K141829 · NBW
Ceragem Medisys, Inc.
Chemistry · 79d
Cleared Sep 24, 2014
REACH ACCESS TELEMEDICINE DOSE CALCULATOR
K142123 · NDC
Reach Health, Inc.
General Hospital · 51d