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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
71641–71664 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 09, 2003
SPSMEDICAL GAS PLASMA CHEMICAL INDICATOR
K030680 · JOJ
Spsmedical Supply Corp.
General Hospital · 65d
Cleared May 09, 2003
ETCHANT 40%
K030743 · KLE
Confi-Dental Products Co.
Dental · 60d
Cleared May 09, 2003
MEGA BITE REGISTRATION - DENTAL BITE REGISTRATION MATERIAL
K030776 · ELW
Discus Dental, Inc.
Dental · 59d
Cleared May 09, 2003
STACKED ABR FOR NAVIGATOR PRO
K030907 · GWJ
Bio-Logic Systems Corp.
Neurology · 46d
Cleared May 09, 2003
C3 PATIENT MONITOR
K030931 · MHX
Analogic Corp.
Cardiovascular · 45d
Cleared May 09, 2003
AESCULAP NEURO PATTIES, NEUROSORB 4, 6, AND 75 (GREEN & WHITE)
K031008 · HBA
Aesculap
Neurology · 39d
Cleared May 09, 2003
NAVITRACK SYSTEM-FLUOROSPINE, MODEL 900.005
K031156 · HAW
Orthosoft, Inc.
Neurology · 28d
Cleared May 09, 2003
SMARTXIDE
K031224 · GEX
Cynosure, Inc.
General & Plastic Surgery · 22d
Cleared May 09, 2003
QUICKIE FREESTYLE POWER WHEELCHAIR, MODEL G-424
K031289 · ITI
Sunrise Medical, Inc.
Physical Medicine · 16d
Cleared May 09, 2003
SYNTHETIC (WHITE) VINYL PATIENT EXAMINATION GLOVES-POWDER FREE
K031293 · LYZ
Shijiazhuang Eversharp Plastic...
General Hospital · 16d
Cleared May 09, 2003
ULTRASONIC GASTROVIDEOSCOPE, TYPE UC160P-AT8 AND UCT160-AT8
K031347 · ODG
Olympus Optical Co., Ltd.
Radiology · 10d
Cleared May 09, 2003
TRANSVAGINAL DOPPLER PROBE
K031358 · ITX
Vascular Control Systems, Inc.
Radiology · 9d
Cleared May 08, 2003
HEADFIX
K030439 · IYE
Medical Intelligence Medizintechnik GmbH
Radiology · 86d
Cleared May 08, 2003
BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET, MODELS 367338, 367344,...
K030573 · JKA
Bd Vacutainer Systems Preanalyical...
Chemistry · 73d
Cleared May 08, 2003
MODIFICATION TO PREMIER III PHASED ARRAY CTL SPINE COIL
K031056 · MOS
Usa Instruments, Inc.
Radiology · 35d
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