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
71665–71688 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared May 06, 2003
EK-PRO ARRHYTHMIA DETECTION ALGORITHM
K031320 · MHX
Ge Medical Systems Information...
Cardiovascular · 11d
Cleared May 05, 2003
BIOMET CRANIOFACIAL ACRYLIC CEMENT
K011399 · GXP
Biomet, Inc.
Neurology · 728d
Cleared May 05, 2003
ECHOPULSE MUSCLE STIMULATOR SYSTEM, MODEL 800
K023230 · IPF
Western Clinical Technology Systems,...
Physical Medicine · 220d
Cleared May 05, 2003
ADHOC CLAW
K023963 · MBI
Future Medical Systems, Inc.
Orthopedic · 157d
Cleared May 05, 2003
PRIMA III TOTALSENSE TORSO COIL
K030371 · MOS
Usa Instruments, Inc.
Radiology · 90d
Cleared May 05, 2003
SOFT-TOUCH TENS ELECTRODE
K030375 · GXY
Pain Management Technologies
Neurology · 90d
Cleared May 05, 2003
POLY PER-Q-CATH PICC CATHETERS
K031129 · LJS
C.R. Bard, Inc.
General Hospital · 26d
Cleared May 05, 2003
SYNTHES (USA) 3.5 MM BROAD LCP & 4.5 MM LCP DISTAL HUMERUS PLATES
K031178 · HRS
Synthes (Usa)
Orthopedic · 21d
Cleared May 05, 2003
CDR PANX, MODEL 4792
K031291 · MUH
Schick Technologies, Inc.
Radiology · 12d