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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
72169–72192 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 08, 2003
GORE-FLEX MP8 MULTIPURPOSE TORSO ARRAY
K031089 · MOS
W.L. Gore & Associates, Inc.
Radiology · 31d
Cleared May 07, 2003
CO2 CLIP
K023820 · CCK
Bregas AB
Anesthesiology · 173d
Cleared May 07, 2003
ARTEGRAL AND POLYSTAR SELECTION
K030588 · ELM
Merz Dental GmbH
Dental · 71d
Cleared May 07, 2003
PD CASTA-H
K030632 · EJH
Mountain Medico, Inc.
Dental · 68d
Cleared May 06, 2003
SURGICAL SIMPLEX P WITH TOBRAMYCIN
K014199 · LOD
Howmedica Osteonics Corp.
Orthopedic · 501d
Cleared May 06, 2003
IMPACT, UNIVERSAL SINGLE-LIMB, VENTILATOR CIRCUIT, MODEL 820-0099-00
K022062 · MOD
Impact Instrumentation, Inc.
Anesthesiology · 315d
Cleared May 06, 2003
READI-LOAD SYSTEM, MODEL PSS 1820RL
K022389 · KXK
Worldwide Medical Technologies, LLC
Radiology · 287d
Cleared May 06, 2003
PEDIATRIC CENTRAL VENOUS CATHETER KIT
K023253 · FOZ
B.Braun Medical, Inc.
General Hospital · 218d
Cleared May 06, 2003
KALAZAR DETECT
K023483 · LOO
Inbios Intl., Inc.
Microbiology · 201d
Cleared May 06, 2003
GAMBRO POLYFLUX 6 LR, 8 LR AND 10 LR
K023615 · MSF
Gambro Renal Products
Gastroenterology & Urology · 190d
Cleared May 06, 2003
VISUALINE CUP IV FOR DRUGS OF ABUSE TEST FOR QUALITATIVE DETERMINATION OF...
K023648 · LDJ
Sun Biomedical Laboratories, Inc.
Toxicology · 188d
Cleared May 06, 2003
ARAMIS II DERMATOLOGICAL LASER
K023734 · GEX
Quantel Medical
General & Plastic Surgery · 180d
Cleared May 06, 2003
CARDIOVASCULAR SONOSPECTROGRAPHIC ANALYZER
K023759 · DQD
Sonomedica
Cardiovascular · 179d
Cleared May 06, 2003
CT COLONOGRAPHY
K023943 · JAK
Ge Medical Systems, Inc.
Radiology · 161d
Cleared May 06, 2003
3D ACCU-I-TOMO XYZ SLICE VIEW TOMOGRAPH
K030450 · JAK
J. Morita USA, Inc.
Radiology · 84d
Cleared May 06, 2003
LAC-MAC LIMITED INNERBLOC O.R. GOWN
K030536 · FYA
Lac Mac, Ltd.
General Hospital · 75d
Cleared May 06, 2003
SURETEMP PLUS
K030580 · FLL
Welch Allyn, Inc.
General Hospital · 71d
Cleared May 06, 2003
BELLEGLASS POINT 4
K030646 · EBD
Kerr Dental Materials Center
Dental · 67d
Cleared May 06, 2003
MONO-SWIFT
K030786 · NEW
Cp Medical
General & Plastic Surgery · 55d
Cleared May 06, 2003
DISPOSABLE POWDER FREE VINYL EXAM GLOVES WITH VITAMIN E
K031072 · LYZ
Shanghai Palomar Mountain Industries,...
General Hospital · 32d
Cleared May 06, 2003
LUMINEXX ENDOSCOPIC BILIARY STENT
K031186 · FGE
C.R. Bard, Inc.
Gastroenterology & Urology · 21d
Cleared May 06, 2003
CARD EP
K031261 · JAK
GE Medical Systems
Radiology · 15d
Cleared May 06, 2003
ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS
K031270 · DHX
Beckman Coulter, Inc.
Immunology · 15d
Cleared May 06, 2003
RTA MODEL D RETINAL THICKNESS ANALYZER
K031312 · HLI
Talia Technology , Ltd.
Ophthalmic · 12d