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.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,724 results
68593–68616 of 174,724
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 01, 2004
ART POSTERIOR SPINAL SYSTEM
K033150 · MNI
Advanced Medical Technologies AG
Orthopedic · 153d
Cleared Mar 01, 2004
VITAL SIGNS MONITOR, PROPAQ LT
K033378 · MWI
Welch Allyn Protocol, Inc.
Cardiovascular · 131d
Cleared Mar 01, 2004
TRAPMATIC SYSTEM SET
K033616 · KNW
H.S Hospital Service S.P.A
Gastroenterology & Urology · 105d
Cleared Mar 01, 2004
EECP THERAPY SYSTEM MODEL TS4 WITH/WITHOUT PLUSE OXIMETRY
K033617 · DRN
Vasomedical, Inc.
Cardiovascular · 104d
Cleared Mar 01, 2004
SP NEWTRON MODULE
K033764 · ELC
Satelec
Dental · 90d
Cleared Mar 01, 2004
IMALUX OCT IMAGING SYSTEM
K033783 · NQQ
Imalux Coporation
General & Plastic Surgery · 88d
Cleared Mar 01, 2004
BILOK ST SCREW
K033792 · HWC
Biocomposites, Ltd.
Orthopedic · 87d
Cleared Mar 01, 2004
BARD SOFT MESH, MODELS 0117001, 0117002, 0117003, 0117004, 0117005, 0117006,...
K033814 · FTL
C.R. Bard, Inc.
General & Plastic Surgery · 83d
Cleared Mar 01, 2004
MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANELS (GEMIFLOXACIN)
K033948 · LRG
Dade Behring, Inc.
Microbiology · 73d
Cleared Mar 01, 2004
SYNTHES 2.4 MM TITANIUM (TI.) LOCKING SCREWS
K033975 · HWC
Synthes (Usa)
Orthopedic · 69d
Cleared Mar 01, 2004
3.5 MM LCP DISTAL HUMERUS SYSTEM
K033995 · KTT
Synthes (Usa)
Orthopedic · 68d
Cleared Mar 01, 2004
HERADOR EC, PF, C, H, NH, G, GG AND MP
K034049 · EJT
Heraeus Kulzer,GmbH
Dental · 62d
Cleared Mar 01, 2004
CAPIOX FLEXIBLE VENOUS RESERVOIR
K040023 · DTN
Terumo Cardiovascular Systems Corp.
Cardiovascular · 54d
Cleared Mar 01, 2004
ARROW ECHOGENIC INTRODUCER NEEDLE
K040100 · DQX
Arrow Intl., Inc.
Cardiovascular · 41d
Cleared Mar 01, 2004
LSI SEW-RIGHT R SERIES SUTURE PLACEMENT DEVICE AND ACCESS PRODUCT SEW-RIGHT...
K040232 · GAT
Lsi Solutions
General & Plastic Surgery · 28d
Cleared Mar 01, 2004
PERIOGLAS-BIOGLASS BONE GRAFT SUBSTITUTE
K040278 · LYC
Novabone Products, LLC
Dental · 25d
Cleared Mar 01, 2004
PHILIPS INTELLIVUE PATIENT MONITOR, MODELS MP40 & MP50
K040304 · MHX
Philips Medizin Systeme Boeblingen GmbH
Cardiovascular · 21d
Cleared Mar 01, 2004
ARTHROCARE CONTROLLER, CABLE, FOOT CONTROL, POWER CORD, WANDS, MODELS...
K040338 · GEI
Arthrocare Corp.
General & Plastic Surgery · 19d
Cleared Mar 01, 2004
KOMPRESSOR SCREW SYSTEM
K040356 · HWC
Kinetikos Medical, Inc.
Orthopedic · 17d
Cleared Mar 01, 2004
LIGHTSPEED 7.0 CT SCANNER SYSTEM
K040372 · JAK
Ge Medical Systems, LLC
Radiology · 13d
Cleared Feb 27, 2004
EXACTECH RESORBABLE BONE PASTE
K020078 · MQV
Exactech, Inc.
Orthopedic · 779d
Cleared Feb 27, 2004
AMBU PEDIATRIC MULTI-FUNCTION DEFIBRILLATION ELECTRODE
K032421 · MKJ
Ambu, Inc.
Cardiovascular · 206d
Cleared Feb 27, 2004
NEXIVA CLOSED IV CATHETER SYSTEM
K032843 · FOZ
Becton Dickinson Infusion Therapy...
General Hospital · 169d
Cleared Feb 27, 2004
RANDOX URIC ACID
K033278 · CDO
Randox Laboratories, Ltd.
Chemistry · 140d