Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
72793–72816 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared May 02, 2003
HIVOX DREAMATE DM-800
K021952 · GZJ
Hivox Biotek, Inc.
Neurology · 323d
Cleared May 02, 2003
CARECOMPANION PATIENT STATION/CARECOMPANION PATIENT STATION
K023286 · DXN
Neptec Design Group, Ltd.
Cardiovascular · 212d
Cleared May 02, 2003
GLYCA-DIRECT FRUCTOSAMINE
K023654 · LCP
Polymedco, Inc.
Chemistry · 184d
Cleared May 02, 2003
AIRLIFE DEMAND NASAL CANNULA
K023673 · NFB
Allegiance Healthcare Corp.
Anesthesiology · 182d
Cleared May 02, 2003
BOSTON BL-1000-SIM08 MULTI-ACTION SOLUTION
K024289 · MRC
Bausch & Lomb, Incorporated
Ophthalmic · 130d
Cleared May 02, 2003
REPROCESSED ELECTROPHYSIOLOGY CATHETER
K030026 · NLH
Alliance Medical Corp.
Cardiovascular · 119d
Cleared May 02, 2003
NITRILE POWDER-FREE EXAMINATION GLOVES, PROBLUE, #7235 7 #7735
K030207 · LZA
Shanghai Motex Healthcare Co., Ltd.
General Hospital · 101d