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
82921–82944 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 08, 2000
OMEGA II MODULAR TOTAL HIP SYSTEM
K000817 · JDI
Osteoimplant Technology, Inc.
Orthopedic · 87d
Cleared Jun 08, 2000
BIOSORBPDX BIOABSORBABLE FIXATION SYSTEM
K000836 · JEY
Bionx Implants, Inc.
Dental · 86d
Cleared Jun 08, 2000
CADD-PRIZM PCS II MODEL 6101 AMBULATORY INFUSION SYSTEM
K000842 · FRN
Sims Deltec, Inc.
General Hospital · 85d
Cleared Jun 08, 2000
PENADAPT 10
K000904 · FYD
Buffalo Filter Co., Inc.
General Hospital · 79d
Cleared Jun 08, 2000
AU5 ULTRASOUND IMAGING SYSTEM
K000931 · IYN
Biosound Esaote, Inc.
Radiology · 78d
Cleared Jun 08, 2000
SPERM WASH MEDIUM, CAT# 2003/2005
K000989 · MQL
Invitrocare, Inc.
Obstetrics & Gynecology · 72d
Cleared Jun 08, 2000
BIOPRO GLENOID COMPONENT W/ KEEL & W/ POSTS
K001046 · KWS
Biopro, Inc.
Orthopedic · 69d
Cleared Jun 08, 2000
L720 EXAMINATION CHAIR
K001261 · KNC
Luneau Gynecologie SA
Obstetrics & Gynecology · 50d
Cleared Jun 08, 2000
AIRDENT II CS
K001313 · KOJ
Air Technologies, Inc.
Dental · 43d
Cleared Jun 08, 2000
SPERMICIDAL LUBRICATED MALE LATEX CONDOM
K001377 · LTZ
Pleasure Latex Products Sdn. Bhd.
Obstetrics & Gynecology · 38d
Cleared Jun 08, 2000
ALLON 2001
K001546 · DWJ
Mtre Advanced Technology , Ltd.
Cardiovascular · 21d
Cleared Jun 08, 2000
DIDECO LILLIPUT 1 TWIN RESERVOIR WITH PHOSPHORILCHOLINE INSERT SURFACE IN...
K001602 · DTN
Dideco S.P.A.
Cardiovascular · 15d
Cleared Jun 08, 2000
ENGUARD PHX CARDIOPLEGIA HEAT EXCHANGER
K991137 · DTR
Minntech Corp.
Cardiovascular · 430d
Cleared Jun 08, 2000
ENGAGE JAW INSERTS
K992980 · DXC
Novare Surgical Systems, Inc.
Cardiovascular · 279d
Cleared Jun 08, 2000
TRI-BALL
K994074 · BWF
Leventon, S.A.
Anesthesiology · 189d
Cleared Jun 07, 2000
MDA D-DIMER
K000492 · DAP
Organon Teknika Corp.
Hematology · 113d
Cleared Jun 07, 2000
QUANTA LITE LKM-1 ELISA
K000535 · NBS
Inova Diagnostics, Inc.
Immunology · 111d
Cleared Jun 07, 2000
BORLA TRANSDUCER PROTECTOR & HAEMOTRONIC TRANSDUCER PROTECTOR
K000702 · FIB
Fresenius Medical Care North America
Gastroenterology & Urology · 98d
Cleared Jun 07, 2000
HYFRECATOR 2000 REUSABLE HAND-SWITCHING ACCESSORY HANDPIECE/FOOT-SWITCHING...
K001159 · GEI
Conmedcorp
General & Plastic Surgery · 58d
Cleared Jun 07, 2000
ULTRAPEN REUSABLE PENCIL, MODEL 130350 THROUGH 130353, REUSABLE ACCESSORY...
K001161 · GEI
Conmedcorp
General & Plastic Surgery · 58d
Cleared Jun 07, 2000
SELF ADHERING NAVIGUS GUIDE
K001192 · HAW
Image-Guided Neurologics, Inc.
Neurology · 56d
Cleared Jun 07, 2000
THE APTUS, AUTOMATED APPLICATION OF THE GLIADIN IGA ELISA TEST SYSTEM. AN...
K001393 · MST
Zeus Scientific, Inc.
Immunology · 35d
Cleared Jun 07, 2000
AGILENT M2636A TELEMON MONITOR
K001436 · DSI
Agilent Technologies, Inc.
Cardiovascular · 30d
Cleared Jun 07, 2000
ENSITE 3000 SYSTEM, MODEL EE3000
K001437 · DQK
Endocardial Solutions, Inc.
Cardiovascular · 30d